Clinical Chemistry Analyzers, Automated

October 2002
Clinical Chemistry Analyzers, Automated,

Discrete
sample-to-sample interaction and contamination that
Scope of this Product Comparison can occur with continuous-flow instruments. (In con-
This Product Comparison covers automated, dis- tinuous-flow instruments, the chemical reaction takes
crete clinical chemistry analyzers used in clinical place in a continuously flowing stream of liquid, and
or commercial laboratories; it does not include air bubbles and water flush the flow lines between
chemistry analyzers that are designed for bed- specimens to prevent carryover — contamination of
side use (see the Product Comparison titled the sample with residual specimens and reagents.)
POINT-OF-CARE ANALYZERS, CLINICAL LABORA-
Most discrete analyzers are random access — that is,
TORY for more information). For information on sample testing can occur in or out of sequence, in any
other types of clinical chemistry analyzers, see order desired by the user. This sequence-interrupt
the Product Comparison titled CLINICAL CHEM- feature permits stat testing. Some analyzers can per-
ISTRY ANALYZERS, MANUAL.
form analyses such as enzyme immunoassays and
drug assays using other manufacturers’ reagent sys-
tems in addition to their own.
UMDNS information
This Product Comparison covers the following
device term and product code as listed in ECRI’s
Universal Medical Device Nomenclature System™
(UMDNS™):
• Analyzers, Laboratory, Clinical Chemistry,
Automated, Discrete [16-299]
Purpose
Clinical chemistry analyzers determine the concen-
tration of certain metabolites, electrolytes, proteins,
and/or drugs in samples of serum, plasma, urine,
cerebrospinal fluid, and/or other body fluids. Auto-
mated chemistry analyzers provide the laboratory
with walkaway operation and a standardized method
of obtaining accurate and reproducible chemical con-
centration values.
By using separate reaction vessels for each test,
discrete clinical chemistry analyzers reduce the
179894 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

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Healthcare Product Comparison System
Principles of operation a tungsten-halogen quartz lamp; each cuvette is read

Discrete clinical chemistry analyzers use specimens at eight wavelengths every six seconds, and the com-
placed in separate cuvettes, capsules, test tubes, test puter interprets only the specific wavelength for a
packs, or slides. The specimen containers are trans- requested test.
ported on a conveyor or in a carousel past stations
Two methods used by discrete analyzers for chemi-
where specimens are sampled and diluents and re-
cal measurement are end point and kinetic. The end-
agents are dispensed and mixed automatically. Fol-
point method incubates the reaction mixture for a
lowing incubation and color development, a filter
predetermined amount of time to reach the end point,
photometer or spectrophotometer measures the light
or equilibrium, of the reaction. In the kinetic method,
absorbance of the specimen and results are calculated,
the reaction is monitored as the reagents and the
reported, and, where applicable, transferred to a labo-
sample are mixed; the rate of change in absorbance is
ratory information system (LIS). Some analyzers per-
then determined and related to analyte concentration.
form only one test at a time (single channel), while
others perform several simultaneously (multichan- Ion-selective electrodes (ISEs), used in many ana-
nel). lyzers, potentiometrically measure the activity of ions
Filter photometers and spectrophotometers meas- in solution, such as sodium (Na+), potassium (K+), and
ure the absorbance of specific wavelengths as light is chloride (Cl-). The ISE (which contains an electrolyte
passed through the specimen. Filter photometers use solution) and an external reference electrode are ex-
filter systems to isolate these wavelengths from the posed to the unknown sample solution, and the poten-
scanner beam; spectrophotometers use prisms or grat- tial of the sample solution is measured relative to that
ings. Both types of photometers use readers that have of the external reference electrode. As the specific ions
optional components such as computer control mod- under analysis are selectively bound to the ISE, the
ules and automated sample handlers to expedite sam- internal reference electrode detects the potential dif-
ple measurement and data analysis. ference between an internal filling solution and the
sample solution. The potential difference between the
Many of the reactions used in discrete analysis are external reference electrode and the ISE, which is a
colorimetric: a chemical reaction that is specific to an function of the specific ion’s activity (concentration), is
analyte results in a product (a chromagen) whose color amplified and displayed in millimoles per liter.
intensity, measured using a photometric device, is
proportional to the analyte’s concentration in the sam- Most discrete analyzers operate in essentially the
ple. The general procedure of a colorimetric assay same way. The sample tray is loaded with the speci-
involves transferring a measured volume of sample to mens to be analyzed. A probe aspirates a precisely
a cuvette, diluting the sample with a buffer, separating measured aliquot of sample and discharges it into the
protein (in some cases), adding a measured volume of reaction vessel; a measured volume of diluent then
reagent, incubating for color development, and meas- rinses the probe. Reagents are dispensed at precisely
uring the absorbance of color. measured volumes into the reaction vessel. After the
Many analyzers use the principle of bichromatics, a solution is mixed (and incubated, if necessary), it is
technique that eliminates cuvette interferences (e.g., either passed through a colorimeter, which measures
scratches, other light-scattering effects) and can com- its absorbance while it is still in its reaction vessel, or
pensate for some sample interferences (e.g., hemoglo- aspirated into a flow cell, where its absorbance is
bin, lipids). The difference in absorbance at two measured by a flow-through colorimeter. The analyzer
selected wavelengths is determined as a measure of then calculates the analyte’s chemical concentrations.
analyte concentrations. The first reading is taken at or
Some analyzers use special techniques. For exam-
close to the wavelength of maximum absorbance of the
ple, some use dry-tablet reagents in ultraviolet/visible
specific chromagen. The second reading is taken at the
photometric assays. The reagent carousel holds 48
point of minimum absorbance (the absorbances of the
tablet dispensers, each containing a maximum of 300
reagent and sample are very similar), and then the
tablets. Samples, in their original containers, are
second reading is subtracted from the first. Some units
placed directly on the instrument for analysis. Bar
use a polychromatic technique, which uses more than
codes, applied to the collection containers, provide all
two selected wavelengths.
the testing information required for each sample. The
One analyzer uses a spectral isolation optical sys- unit reads the bar code, dispenses one tablet per test
tem, in which a cuvette assembly containing eight into a disposable cuvette, adds diluent to the cuvette,
filters — each with its own detector — rotates around and uses an ultrasonic mixer to dissolve the tablet. The
2 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Clinical Chemistry Analyzers, Automated, Discrete
sample is aspirated from the stoppered tube and added

Pack Header Stopper Test Name Binary Code
to each cuvette, where it is mixed with reagent.
With these systems, light from a single source (e.g.,
a quartz-halogen lamp) is broken into eight beams.
C433UN3A
Each beam is transmitted through light guides to one
of eight photometer stations, where it is directed at the
moving cuvette track. Readings are taken at the ap-
propriate wavelengths at each station. The light that
passes through the cuvette is measured by photomul- Cuvette Area
tiplier tubes; the measurements are sent to a micro-
processor for analysis. If a sample’s analyte
concentration exceeds the procedure’s range of linear-
ity, the system notifies the operator, who can retrieve
the sample and rerun it in the dilute mode: the ana- Reagent Compartments Temporary Seals
lyzer withdraws one-fourth of the original sample vol- Permanent Seal
ume, adds more buffer, and repeats the test.
Figure 1. Reagent pack used with the Dade analyzers
These analyzers also have ISEs to measure concen-
trations of Na+, K+, Cl-, and lithium (Li+); four liquid
reagent channels are available for user-defined tests. form a 1 cm pathlength cuvette. Absorbance is meas-
ured, the concentration value for each test is calcu-
Another type of discrete clinical chemistry analyzer lated, and the results are printed; the used test packs
uses a special plastic test pack containing the reagents are automatically discarded into a waste container.
for one test and a double-walled reaction chamber that
This system uses ISEs to measure Na+, K+, and Li+
forms the cuvette for photometric analysis (see Fig. 1).
concentrations. For example, Li+ concentrations in a
On the top of each test pack is a rigid header, a plastic
sample are determined using the interaction of Li+
block used to move the pack through its processing
with an ionophore (a molecule that increases cell mem-
steps by means of a transport chain. The header may
brane permeability to specific ions) contained in a
incorporate a chromatographic column for removing
polyvinyl chloride membrane. The sample is aspirated
interfering substances or a gel-filtration matrix for
and delivered directly into the electrode measuring
retarding small molecules. Temporary seals surround
chamber, and the results are printed on a report form.
the compartments containing the tablet or liquid re-
agents; the reaction chamber itself is surrounded by a One analyzer uses fluorescence polarization (FP) for
permanent seal. the measurement of therapeutic drug levels and for
thyroid-function tests. With FP, the patient sample, the
The sample is introduced into the unit, followed by
FP sample dilution reagent, and the assay-specific an-
the reagent packs in the order in which the tests are
tibody are mixed together. Assay-specific tracer, a
to be performed. The sample is automatically aspi-
drug-fluorescein conjugate, is then added to the mix-
rated and delivered into each test pack, filtering
ture and binds to the assay-specific antibody. When
through the column to remove interfering substances
exposed to polarized light of the appropriate wave-
and proteins. The built-in computer reads an identifi-
length, a fluorescent molecule — a fluorophore — will
cation code on the pack header, which indicates the
absorb some of the light to emit it at a subsequently
test to be performed, its sample size, diluent type and
longer wavelength. Smaller molecules, such as free
volume, incubation time, and required photometric
analyte-tracer, can rotate rapidly, leading to a greater
wavelengths. The individual packets move on a trans-
depolarization of emitted light. Larger molecules, such
port chain through the temperature-controlled proc-
as the analyte-tracer bound to an antibody, rotate more
essing chamber, and applied pressure breaks the
slowly and emit light of lesser depolarization. Thus, as
temporary seals on the reagent compartments to add
the concentration of analyte increases, more unbound
the necessary reagents to the reaction vessel. The
analyte-tracer will be present, resulting in greater de-
packet contents are mixed by vibration and trans-
polarization at increasing analyte concentrations.
ported through delay stations, where the reaction
takes place. Once incubation is complete, the last re- In addition to performing FP analyses, this system
agent compartments are broken, the contents are re- also uses photometric and ISE methods to measure
mixed, and the packet is moved to the filter concentrations of enzymes, drugs of abuse, electro-
photometer, where it is mechanically compressed to lytes, and various other compounds.
©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 3
On other analyzer systems, once patient samples

are pipetted into sample cups or once sample drawing
tubes are directly loaded into sample trays, automated
analysis begins. Colorimetric assays by reflectance
photometry use a dry, multilayered, thin-film slide
(see Fig. 2). The top layer is microscopically porous and
distributes the serum evenly over the film, acting as a
filter to reduce or eliminate interferences before the
serum penetrates the reagent layer. The indicator
layer produces a dye with an intensity proportional to
the concentration of the particular analyte in the sam-
ple. A support layer acts as an optical diffuser against
which the dye intensity is measured by reflectance
photometry.
Potentiometric analyses for Na+, K+, Cl-, and carbon

dioxide (CO2) are performed on a single-use ISE slide
containing two thin-film ISEs joined by a paper bridge
(see Fig. 3). The sample is dispensed onto one section
of the slide, while a reference liquid is dispensed onto
the other. This process creates a half-cell, which is
connected to an identical half-cell formed from the
reference solution. The junction forms within 20 to 30
seconds, and a measurable analytical potential is
reached in about 3 minutes. The potential difference
between the two half-cells is measured by a voltmeter
and is directly proportional to the activity (and there- Figure 3. Ortho-Clinical Diagnostics Vitros clinical
fore the concentration) of electrolytes in the sample. chemistry slide for potentiometry
Reported problems
Although less of a problem than in continuous-flow
systems, carryover can occur on a sample probe or
reagent probes, in reusable cuvettes, or — in systems
using disposable cuvettes — as a result of residual
specimen in the pipetting system.
Because of the small sample volume, any interfer-

ence (such as lipemia or hemolysis in colorimetric
assays) can cause an inaccurate measurement. Many
discrete analyzers compensate by running a sample
blank (a test tube containing only sample) at the same
time and under the same conditions as the actual test.
Subtracting the blank’s absorbance from the sample’s
absorbance gives the correct absorbance for calculat-
ing the result.
The waste generated by discrete chemistry analyz-

ers contains blood or body fluids; therefore, operators
must determine the appropriate waste disposal meth-
ods according to federal, state, and local medical waste
regulations. Some labs may be permitted to discard
untreated waste through the sewer system, while oth-
ers may be required to disinfect wastes with household
Figure 2. Ortho-Clinical Diagnostics Vitros clinical bleach, formalin, formaldehyde, or glutaraldehyde (in
chemistry slide appropriate dilution ratios) before disposal. Users of
slide reagents and test packs should also determine • Requiring relatively little time and training to learn
appropriate waste disposal requirements. to operate, based on the degree of sophistication of
the equipment and the level of experience, compe-
Analyzers that require a water reagent hookup may
tence, and training of the laboratory personnel who
sometimes have water contamination problems — the
will operate it
presence of ions such as Na+ and Cl-, for instance —
that can affect test results. Special water treatment In addition to these basic requirements, other ana-
systems that feed directly into the analyzer may be lyzer features that should be considered are walkaway
necessary. capability, preferred report format, bar-code reading
capability, the ability to use different sample tube sizes
Some reagents/reagent slides must be stored at low
and run different types of samples, automated sample
temperatures (i.e., frozen or refrigerated). Prepara-
dilution, onboard reagent stability, and closed-tube
tion time must include thawing or warming before
sampling (which reduces risk of operator exposure to
use. Many analyzers have onboard refrigeration for
biohazardous materials). ECRI recommends that all
reagents.
instruments have alarms that can alert users to any
Problems occur with some analyzers’ software pack- system failure (e.g., insufficient reagents, out-of-range
ages; however, these are generally corrected by en- errors) that can produce false results.
hancements released by the manufacturer.
Buyers should be aware that an analyzer’s through-
Problems with mislabeled reagent containers, pack- put depends on the number and type of tests performed
age inserts, standards, and/or calibrators are fre- by the instrument during a particular time. Very high
quently reported. Labeling misinformation can cause throughput claims by a manufacturer may be based on
inaccurate or false chemistry results, which can lead tests that react rapidly to the addition of chromagenic
to misdiagnoses and inappropriate patient care. Users reagent (i.e., have short incubation times) and quickly
are advised to be alert for any recalls involving misla- show measurable results. Manufacturers should reveal
beled reagents. the test profile — the number and kinds of tests —
used to determine analyzer throughput claims.
Purchase considerations Final regulations of the Clinical Laboratory Im-

provement Amendments of 1988 (CLIA) were publish-
A clinical chemistry analyzer, like any other ana-
ed in February 1992 by the U.S. Department of Health
lytical instrument, must provide consistently accurate
and Human Services (DHHS). Under the CLIA regu-
and timely test data to be cost-effective. An inexpen-
lations, all clinical laboratories are required to obtain
sive analyzer with low-cost reagents that breaks down
federally issued certificates. To acquire a certificate, a
frequently, requires a high percentage of repeat tests,
lab must meet all relevant standards, which are deter-
and is labor-intensive to use may cost more over time
mined by the complexity of the tests being performed.
than a more expensive analyzer that is durable, ana-
The standards set forth in CLIA apply to areas such as
lyzes samples accurately and reliably, and is relatively
patient test management, quality control (QC), profi-
easy to operate. But before considering instrument
ciency testing, personnel qualifications, and quality
quality, a laboratory must determine whether its own
assurance (QA) programs. Certification fees vary ac-
chemistry needs and requirements correspond with
cording to complexity level and test volume. There are
the capabilities of the analyzer.
three different levels of complexity outlined in the
Purchasers should consider a discrete analyzer that CLIA regulations — waived, moderate complexity,
can fulfill laboratory requirements such as the following: and high complexity.
• Performing the kinds of tests and test profiles (i.e., Waived tests require little or no training or experi-
combinations of tests) requested by the physicians ence to perform, do not require elaborate QC, and
in the facility therefore are less likely to produce inaccurate results.
Nonautomated dipstick urinalysis is one of several
• Processing the specimen workload; stat test counts
waived tests.
should be considered separately from nonemer-
gency tests in calculating the needed throughput The moderate-complexity category encompasses
most clinical laboratory tests, including automated
• Handling the workflow (i.e., the varying numbers of
urine, blood, and chemistry analyses. Tests and ana-
specimens submitted to the laboratory throughout
lyzers in this group require a limited amount of sample
the day)
and reagent preparation, as well as limited operator
• Fitting in available laboratory space intervention during the analytical process.
The high-complexity classification covers more spe- use a water reagent supply. Analyzer water costs can
cific testing, which requires extensive education and range from a relatively small amount to a significant
training in the specialty. Procedures that necessitate portion of an instrument’s overall operating costs,
a high degree of operator preparation, calibration, depending on water use and local water prices.
intervention, and analysis, such as clinical cytogenics
and histopathology applications, are placed in the An effective QC system is an important cost-con-
highly complex category. tainment consideration. An inappropriate system can
result in unnecessary test runs, delayed patient re-
Before purchasing new equipment or upgrading ex- sults, and failed proficiency tests, all of which waste
isting equipment, laboratories should thoroughly in- time and money. If the correct QC system is used, a
vestigate the CLIA regulations that apply to their large percentage of such waste can be eliminated. The
facility and to the devices being considered. In certain cost and expiration date of QC material and the fre-
situations, purchasing or upgrading a device may quency of test runs can significantly affect the overall
change the complexity category of the procedures. This reagent and analyzer costs.
could require additional staff training and certifica-
tion, as well as changes in QC, proficiency testing, QA State-of-the-art computer-driven instruments can
programs, and other laboratory procedures. become obsolete in a very short time if they cannot be
adapted for future advances in hardware development
With clinical chemistry analyzers, an important or accept software upgrades. Analyzers that have the
consideration is the system’s computer interface capa- flexibility to accept these kinds of improvements have
bilities. The effectiveness of the interface with the a long-term advantage over those that do not. By the
existing LIS or the hospital’s central computer system same token, analyzers that have open channels can be
is crucial to inputting test data, verifying testing accu- programmed to perform new analytical tests as they
racy, and maintaining QC, calibration, proficiency are developed by the instrument manufacturer.
testing, and patient files according to CLIA guidelines.
Although CLIA does not mandate computerized re- Because chemistry analyzers entail ongoing main-
porting systems in hospital laboratories, it does re- tenance and operational costs, the initial acquisition
quire facilities to have a system in place to ensure cost does not accurately reflect the total cost of owner-
compliance with CLIA performance standards for QC ship. Therefore, a purchase decision should be based
and QA of patient testing instruments and procedures. on issues such as life-cycle cost (LCC), local service
An effective LIS interface is a fast and efficient way to support, discount rates and non-price-related benefits
manage the large volume of test data that a laboratory offered by the supplier, and standardization with ex-
generates each day, as well as a convenient method of isting equipment in the department or hospital (i.e.,
organizing and storing data needed to comply with purchasing all analyzers from one supplier).
CLIA and other inspection agencies’ requirements.
(See the Product Comparison titled INFORMATION SYS- An LCC analysis can be used to compare high-cost
TEMS, LABORATORY for more information.) alternatives and/or to determine the positive or nega-
tive economic value of a single alternative. For exam-
Cost containment ple, hospitals can use LCC analysis techniques to
examine the cost-effectiveness of leasing or renting
Hospitals should perform a cost assessment of the
equipment versus purchasing the equipment outright.
instrument’s operating features, such as its testing
Because it examines the cash-flow impact of initial
reliability and accuracy, cost per reportable result, stat
acquisition costs and operating costs over a period of
time, average downtime, QC and calibration methods
time, LCC analysis is most useful for comparing alter-
and frequency, start-up procedures and time, labor,
natives with different cash flows and for revealing the
consumables, maintenance, and service costs. Also in-
total costs of equipment ownership. One LCC tech-
cluded in this assessment should be nonoperational
nique — present value (PV) analysis — is especially
but essential expenses such as those for instrument
useful because it accounts for inflation and for the time
installation (e.g., some analyzers require special
value of money (i.e., money received today is worth
plumbing and/or water filters), the disposal costs for
more than money received at a later date). Conducting
solid and liquid waste generated by the unit, and costs
a PV/LCC analysis often demonstrates that the cost of
for reagent preparation and storage.
ownership includes more than just the initial acquisi-
In addition to reagents and disposables such as tion cost and that a small increase in initial acquisition
cuvettes, reaction cups, and ISEs, the cost of consu- cost may produce significant savings in long-term op-
mables should also include an estimate of the amount erating costs. The PV is calculated using the annual
of water used over a specified time by analyzers that cash outflow, the dollar discount factor (the cost of
capital), and the lifetime of the equipment (in years) in Alternative 1 — Outright Purchase
a mathematical equation.
Capital Costs
The following analyses are based on approximately • System = $164,000
40,000 tests per month on one analyzer with one full-
time employee (FTE). Suppliers frequently offer vari- Total Capital Costs = $164,000
ous purchase/lease options on their equipment. Three Operating Costs
common options on chemistry analyzers are outright
purchase, monthly lease, and reagent contracts. Pur- • Service contract, years 2 through 5 = $16,400/year
chase usually requires initial capital for acquisition of • Salary and expenses for 1 FTE = $40,000/year
the equipment, ongoing costs for reagents and consu-
mables, and purchase of a service contract, which is • Reagents = $100,000/year
typically 8% to 12% of the list price for the system. A • Consumables = $15,000/year
lease can involve monthly payments that include a
service contract and additional ongoing costs for re- Total Operating Costs = $155,000 for year 1;
agents and consumables. A reagent contract usually $171,400/year for years 2 through 5
does not entail an initial acquisition fee or a separate
service contract fee but does require an agreement to PV = ($947,844)
purchase all reagents from the supplier on a cost-per-
Alternative 2 — Reagent Contract
test (CPT) or cost-per-reportable-test(CPRT) basis; the
cost generally depends on the number and type of tests Capital Costs
that will be performed per year. Equipment and serv- • System = No charge
ice costs are usually included in the CPT/CPRT calcu-
lation. Prices for the various arrangements may vary Total Capital Costs = $0
greatly depending on facility size, number of units Operating Costs
being purchased, and previous experience with the
supplier. Prices for reagents and consumables may be • Salary and expenses for 1 FTE = $40,000/year
fixed for a certain number of years (e.g., two years) and
• Reagents and consumables = $250,000/year for
then increase up to 4% annually. Individual suppliers
years 1 and 2
should be contacted to find out what options are avail-
able for a specific facility. • Reagents and consumables = $257,500 for year 3
Disposables are a significant part of the operating • Reagents and consumables = $265,225 for year 4
cost, and that cost can vary greatly depending on • Reagents and consumables = $273,182 for year 5
supplier discounts and incentives. ECRI’s
PriceGuide™ service benchmarks the price you pay for Total Operating Costs = $290,000/year for years 1
single-use medical products. PriceGuide compares and 2, $297,500 for year 3, $305,225 for year 4, and
your hospital’s current pricing data with the national $313,182 for year 5
or regional average and lowest recorded prices paid.
For more information, contact ECRI. PV = ($1,387,038)
The following represent sample five-year PV/LCC Alternative 3 — Straight Lease

analyses for an automated, discrete clinical chemistry Capital Costs
analyzer.
• System = $33,000/year
Present Value/Life-Cycle Cost Analysis Total Capital Costs = $33,000/year
Operating Costs
Assumptions
• Salary and expenses for 1 FTE = $40,000/year
• Operating costs are considered for years 1 through 5 • Reagents = $100,000/year
• Dollar discount factor is 5.75% • Consumables = $15,000/year

Total Operating Costs = $155,000/year
• Inflation rate is 4% for support costs and 3% for
disposables PV = ($1,166,193)
Other costs not included in the above analyses that Buyers should also negotiate for a nonobsolescence
should be considered for budgetary planning include clause stating that the supplier agrees not to introduce
the following: a replacement system within the next one or two years
and that if a replacement system is introduced during
• Software upgrades not included under warranty or
this time period, 100% of the purchase price can be
in service contract
applied to the purchase of the new system.
• Utilities (e.g., water, installation)
In addition, given the current highly competitive
As illustrated by the above sample PV/LCC analy- market for clinical chemistry equipment, hospitals
ses, the initial acquisition cost is only a fraction of the should negotiate for a significant discount — some
total cost of operation over five years. Therefore, rather suppliers may discount up to 20% or 30%. The actual
than making a purchase decision based solely on the discount received will depend on the hospital’s negoti-
acquisition cost of a clinical chemistry system, buyers ating skills, the system configuration and model to be
should consider operating costs over the lifetime of the purchased, the number of units being purchased, pre-
equipment. vious experience with the supplier, and the extent of
Also, it can be concluded that the best option for this concessions granted by the supplier, such as extended
sample situation is outright purchase. However, dif- warranties, fixed prices for annual service contracts,
ferent options may be more economical in other situ- and guaranteed on-site service response. Buyers
ations, depending on a hospital’s needs and budget. should make sure that applications training is in-
Each facility must have a specific analysis done based cluded in the purchase price of the system. Some
on its own situation to determine its most effective suppliers offer more extensive on-site or off-site train-
choice. ing programs for an additional cost.
ECRI recommends that buyers consider the number
For further information on PV/LCC analysis, cus-
and types of tests performed before deciding on a
tomized analyses, and purchase decision support,
specific system configuration. Also, if multiple analyz-
readers should contact ECRI’s SELECT™ Group.
ers are being purchased, hospitals should consider the
Purchasers should carefully evaluate the manufac- types of systems and capabilities that need to be pur-
turer’s service, which should include 24-hour hotline chased to avoid paying for unnecessary analysis pack-
access. They should also inquire about the terms of the ages. For instance, a hospital may want to purchase
warranty (e.g., some warranties may not include pre- two analyzers: one dedicated to routine general chem-
ventive maintenance visits), as well as what service istry profiles and one used for stat testing. In this case,
contracts are available, what they include, and what purchasing both analyzers from one supplier could
discounts are available if the contracts are purchased result in a significant discount. Standardization of
at the same time as the instrument. Hospitals can equipment can make staff training easier, simplify
purchase service contracts or service on a time-and- servicing and parts acquisition, and provide greater
materials basis from the supplier. Service may also be bargaining leverage when negotiating new equipment
available from a third-party organization. purchases and/or service contract costs.
Most suppliers provide routine software updates, Current analyzer users are also valuable sources of
which enhance the system’s performance, at no charge information on the quality, reliability, and overall ef-
to service contract customers. Furthermore, software ficiency of the instruments. When considering an in-
updates are often cumulative; that is, previous soft- strument, buyers should ask analyzer manufacturers
ware revisions may be required in order to install and to supply an unedited list of their customers.
operate a new performance feature. Also, many suppli-
ers do not extend system performance and uptime Stage of development
guarantees beyond the length of the warranty unless
New models of discrete clinical chemistry analyzers
the system is covered by a service contract.
are continually being introduced that offer more varie-
ECRI recommends that, to maximize bargaining ties of tests, greater stat testing capabilities, higher
leverage, hospitals negotiate pricing for service con- throughput, and step-saving features, such as direct
tracts before the system is purchased. Additional serv- sampling from the primary tube. Discrete clinical
ice contract discounts may be negotiable for chemistry analyzers continue to offer greater automat-
multiple-year agreements purchased up front at the ion (largely through software enhancements), require
time of acquisition or for service contracts that are less direct specimen handling, and involve fewer steps
bundled with contracts on other analyzers in the de- for operation and maintenance. Most analyzers fea-
partment or hospital. ture bar codes for sample and/or reagent identification.
Additional enhancements to components such as sam- Griffiths J. Automation and other recent develop-
ple trays include separate quadrant pieces that allow ments in clinical chemistry. Am J Clin Pathol 1992
continuous addition of samples, as well as adapters Oct;98(4 Suppl 1):S31-4.
that conform to cups, sample tubes, and dilution tubes.
Liu-Allison LY, Hui RA, Schwenzer KS. Analysis of
Data management systems play an important role lidocaine on the Cobas™ Integra. Ann Clin Lab Sci
in chemistry analyzers and many other kinds of auto- 1997;27(2):105-15.
mated analytical devices in the clinical laboratory.
These systems provide a bidirectional interface be- Ng RH. More on CK-MB [tips on technology]. MLO
tween the instrument and the LIS or hospital informa- Med Lab Obs 1991 Nov;23(11):11-2.
tion system and often link two or more kinds of
Palmer SM, Kaufman RA, Salamone SJ, et al. Cobas™
equipment to these computer systems, helping to coor-
Integra: clinical laboratory instrument with con-
dinate the ordering of tests to various instruments in
tinuous and random-access capabilities. Clin Chem
the laboratory and the reporting of test results to
1995;41(12):1751-60.
several locations in the facility.
A significant new development is complete clinical Plaut D, Schaefer L. A timesaving QC planning and
laboratory automation using robotics technology. A design tool that uses QAP data. Am Clin Lab 1996
wide range of systems is available; some automate the Jan-Feb:6-8.
entire laboratory, while others merely automate cer-
Solsky RL. Ion-selective electrodes. Anal Chem 1990
tain procedures. Systems can be configured to meet the
Jun 15;62(12):21R-33R.
needs and testing volumes of individual laboratories.
Labs may purchase devices for just front-end sample U.S. Department of Health and Human Services. Clini-
handling or conveyor-belt systems with mobile robots cal Laboratory Improvement Amendments of 1988
to completely automate almost all the laboratory pro- (CLIA). Fed Regist 1992 Feb 28;57(40):7002-288.
cedures. Many analyzer manufacturers provide adap-
tations on their units to accommodate laboratory Standards and guidelines
robotics.
Note: Although every effort is made to ensure that the
Automation can be used for a variety of reasons; following list is comprehensive, please note that other
some labs may want to increase test volume and applicable standards may exist.
throughput without adding staff. Others may use ro-
botics to reduce staffing costs. Each facility’s situation American Association for Clinical Chemistry, Inc.
will determine the type of system (if any) that is most Guidelines for providing quality stat laboratory
appropriate. Automation can be very expensive in- services. Laboratory Quality Assurance Committee.
itially but may contribute to cost savings in the long 1987.
run. There is little information currently available on American Board of Clinical Chemistry. Standards,
the cost versus savings of total laboratory automation. requirements, and procedures for certification.
More information is continually being gathered and 1996.
published; facilities should carefully investigate the American National Standards Institute. Preparation
benefits and drawbacks of the available systems and of manuals for installation, operation, and repair of
configurations before making a decision. laboratory instruments [standard]. ANSI/NCCLS
ASI-1-1981. 1981.
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quirements for safety. Amendment 2 [standard]. Preparation and testing of reagent water in the
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quirements for safety. Section 1. Collateral standard: Procedures for the handling and processing of blood
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IEC 60601-1-1 (1992-06). 1992. 1999).
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11). 1995.
Medical electrical equipment — part 1: general re- U.S. Department of Health and Human Services. Food
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(1990-09). 1990.
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Supplier information Alfa Wassermann SpA [255224]

via Ragazzi del 99 5
Abbott Bologna BO I-40133
Italy
Abbott GmbH [152996] Phone: 39 (051) 6489511
Postfach 2103 Fax: 39 (051) 3889993
Max-Planck-Ring 2-4 E-mail: info@alfawassermann.it
D-65007 Wiesbaden/Delkenheim Internet: http://www.alfawassermann.it
Germany
Phone: 49 (6122) 580
Fax: 49 (6122) 581220 Audit
E-mail: klaus.schatton@abbott.de Audit Diagnostics [312423]
Internet: http://www.abbott.de 2 Westlink Park
Abbott Laboratories [102166] Doughcloyne
100 Abbott Park Rd County Cork
Abbott Park IL 60064 Ireland
Phone: (847) 937-6100, (800) 323-9100 Phone: 353 (21) 4341455
Internet: http://www.abbott.com Fax: 353 (21) 4341604
E-mail: info@auditdiagnostics.ie
Abbott Laboratories Ltd [361920]
Internet: http://www.auditdiagnostics.ie
Station Centre-ville
PO Box 6150
Montreal PQ H3C 3K6 Bayer
Canada
Bayer AG [140715]
Phone: (514) 832-7000, (800) 361-7852
Bayerwerk
Fax: (514) 832-7333
D-51368 Leverkusen 1
Internet: http://www.abbott.ca
Germany
Abbott Laboratories (S) Pte Ltd Phone: 49 (214) 301
Diagnostics Div [306942] Fax: 49 (214) 3066328
1 Maritime Square #11-19 Lobby C Internet: http://www.bayer.com
World Trade Centre
Bayer Corp
Singapore 099253
Diagnostics Div [223454]
Republic of Singapore
511 Benedict Ave
Phone: 65 2788343
Tarrytown NY 10591-5097
Fax: 65 2708873
Phone: (914) 631-8000, (800) 255-3232
Internet: http://www.abbott.com.sg
Fax: (914) 524-2132
Internet: http://www.bayerdiag.com
Alfa Wassermann
Bayer (Singapore) Pte Ltd [307276]
Alfa Wassermann bv [392249]
9 Benoi Sector
Pompmolenlaan 24
Singapore 629844
Postbus 497
NL-3440 GK Woerden
Phone: 65 2613389
The Netherlands
Fax: 65 2663376
Phone: 31 (348) 487300
Internet: http://www.bayerdiag.com
Fax: 31 (348) 433000
E-mail: office@sbs.nl
Internet: http://www.sbiosys.com Beckman Coulter
Alfa Wassermann Inc [392250] Beckman Coulter Inc [340083]
4 Henderson Dr 4300 N Harbor Blvd
West Caldwell NJ 07006 Fullerton CA 92834-3100
Phone: (973) 882-8630, (800) 220-4488 Phone: (714) 871-4848, (800) 526-7694
Fax: (973) 276-0383 Fax: (714) 773-8283
E-mail: info@alfawassermannus.com E-mail: twarren@beckman.com
Internet: http://www.alfawassermannus.com Internet: http://www.beckmancoulter.com
Beckman Coulter Instruments France SA Dade Behring GmbH [329465]

[175263] Postfach 1140
Paris Nord II 33 rue des Vanesses D-35001 Marburg
boite postale 50359 Villepinte Germany
F-95942 Roissy CDG Cedex Phone: 49 (6421) 393
France Fax: 49 (6421) 394941
Phone: 33 (1) 49909000
Fax: 33 (1) 49909010 Dade Behring Inc [329458]
E-mail: beckman_france@beckman.com 1717 Deerfield Rd
Internet: http://www.beckman.com PO Box 778
Deerfield IL 60015-0778
Beckman Coulter Instruments GmbH [175266] Phone: (847) 267-5300, (800) 241-0420
Frankfurter Ring 115 Fax: (847) 267-1066
D-80807 Muenchen Internet: http://www.dadebehring.com
Germany
Phone: 49 (89) 359700
Fax: 49 (89) 35870490 Elan Diagnostics
Internet: http://www.beckman.com
Elan Diagnostics [362152]
Beckman Coulter Instruments (S) Pte Ltd 2 Thurber Blvd
[306950] Smithfield RI 02917
116 Changi Road #03-01 Phone: (401) 233-3526, (800) 733-4424
Singapore 419718 Fax: (401) 233-6480
Republic of Singapore E-mail: sismktg@elandiagnostics.com
Phone: 65 3393633 Internet: http://www.elandiagnostics.com
Fax: 65 3366303
Biotecnica Hycel
Biotecnica Instruments SpA [175052] Hycel Diagnostics [175047]
via Licenza 18 4 rue Galvani
I-00156 Roma F-91745 Massy Cedex
Italy France
Phone: 39 (06) 4112316 Phone: 33 (1) 64531515
Fax: 39 (06) 4103079 Fax: 33 (1) 64531520
E-mail: bt@biotecnica.it E-mail: hycel.com@wanadoo.fr
Internet: http://www.biotecnica.it Internet: http://www.hycel-diagnostics.com
CGA
Instrumentation
CGA Strumenti Scientifici SpA [336997]
via Luca Giordano 7/B Instrumentation Laboratory Co [101922]
I-50132 Firenze FL 101 Hartwell Ave
Italy Lexington MA 02421-3125
Phone: 39 (055) 571476 Phone: (781) 861-0710, (800) 955-9525
Fax: 39 (055) 5000889 Fax: (781) 861-1908
E-mail: support@ilww.com
Dade Behring Internet: http://www.ilus.com
Dade Behring Asia Ptd Ltd [329466] Instrumentation Laboratory GmbH [283451]
15 McCallum Street Klausnerring 4
#04-01 Natwest Centre D-85551 Kichheim bei Muenchen
Singapore 069045 Germany
Republic of Singapore Phone: 49 (89) 907070
Phone: 65 2967787 Fax: 49 (89) 90907116
Fax: 65 2966478 E-mail: support@ilww.com
Internet: http://www.dadebehring.com Internet: http://www.ilww.com
Instrumentation Laboratory SpA [156052] Metrolab

viale Monza 338
Metrolab [171714]
I-20128 Milano MI
Misiones 1156
Italy
1876 Bernal
Phone: 39 (02) 25221
Pcia de Buenos Aires
Fax: 39 (02) 2575250
Argentina
E-mail: support@ilww.com
Phone: 54 (11) 42592607
Internet: http://www.ilww.com
Fax: 54 (11) 42592321
C H Werten and Instrumentation Laboratory E-mail: metrolab@giga.com.ar
[273752] Internet: http://www.metrolab.com.ar
Aragon 90
Apartado de Correos 35027 Olympus
E-08015 Barcelona Olympus America Inc
Spain Scientific Equipment Group [185157]
Phone: 34 (93) 4010101 Two Corporate Center Dr
Fax: 34 (93) 4513745 Melville NY 11747-3157
E-mail: info@chwerten.com Phone: (631) 844-5000, (800) 446-5967
Internet: http://www.ilww.com Fax: (631) 844-5111
E-mail: micro@olympus.com
Internet: http://www.olympus.com
JEOL
Olympus Beijing [276351]
JEOL Ltd [140223] Room No 3406 Beijing Jing Guang Center
3-1-2 Myashino 3 Hu Jia Lou Chao Yang Qu
Akishima City Beijing
Tokyo 196-8558 People’s Republic of China
Japan Phone: 86 (10) 65012084
Phone: 81 (4) 25422187
Olympus Optical Co (Europa) GmbH [155981]
Fax: 81 (4) 25465757 Wendenstrasse 14-18
E-mail: jeoltky@jeol.co.jp Postfach 104908
Internet: http://www.jeol.com
D-20097 Hamburg
Germany
Phone: 49 (40) 237730
KDK
Fax: 49 (40) 23773655
ARKRAY Inc [377486] E-mail: endointer@olympus-europa.com
57 Nishi Aketa-cho Higashi Kujo Internet: http://www.olympus-europa.com
Minami-ku Olympus Singapore Pte Ltd [276169]
Kyoto 601-8045 491B River Valley Rd
Japan #12-01/04 Valley Point Office Tower
Phone: 81 (75) 6628967 Singapore 248373
Fax: 81 (75) 6628973 Republic of Singapore
E-mail: terashima@arkray.co.jp Phone: 65 8340010
Internet: http://www.arkray.co.jp Fax: 65 834 243816
E-mail: pr_dept@olympus.co.jp
Internet: http://www.olympus.co.jp
LSI
Ortho-Clinical Diagnostics
Landmark Scientific Inc [155084]
101-B Creek Ridge Rd Ortho-Clinical Diagnostics
Greensboro NC 27406 A Johnson & Johnson Co [105249]
Phone: (336) 373-0274, (800) 247-5117 1001 US Hwy 202
Fax: (336) 373-1326 Raritan NJ 08869
E-mail: sales@landmarkscientific.com Phone: (908) 218-8000, (800) 292-0152
Internet: http://www.landmarkscientific.com Internet: http://www.orthoclinical.com
Ortho-Clinical Diagnostics (England) Roche Diagnostics

A Johnson & Johnson Co [172107]
PO Box 690 Roche Diagnostics Asia Pacific Pte Ltd [391901]
Mandeville House 62 The Broadway 298 Tiong Bahru Road
Amersham, Buckinghamshire HP10 9VF #16-01/06 Tiong Bahru Plaza
England Singapore 168730
Phone: 44 (1494) 431717 Republic of Singapore
Fax: 44 (1494) 431165 Phone: 65 2727500
Internet: http://www.orthoclinical.com Fax: 65 3716600
Internet: http://www.roche.com/diagnostics
Ortho-Clinical Diagnostics GmbH
Roche Diagnostics (Austria) GmbH [391902]
A Johnson & Johnson Co [284789]
Engelhorngasse 3
Karl-Landsteiner-Strasse 1
A-1211 Wien
Postfach 1340
Austria
D-69141 Neckargemuend
Phone: 43 (1) 277870
Germany
Fax: 43 (1) 2778712
Phone: 49 (6223) 77242
Fax: 49 (6223) 77278
Internet: http://www.orthoclinical.com Roche Diagnostics (Canada) [351509]
201 Blvd Armand-Frappier
Ortho-Clinical Diagnostics (Singapore) Laval PQ H7V 4A2
A Johnson & Johnson Co [307310] Canada
1 Maritime Square Phone: (450) 686-7050, (800) 361-2070
#10-22A Lobby B World Trade Centre Fax: (450) 686-7011
Singapore 099253 Internet: http://www.roche.com/diagnostics
Phone: 65 2760398 Roche Diagnostics Corp [391899]
Fax: 65 2760389 9115 Hague Rd
Internet: http://www.orthoclinical.com Indianapolis IN 46256
Phone: (317) 845-2000, (800) 428-5074
Fax: (317) 845-2221
Precision Systems
Precision Systems Inc [101934] Thermo LabSystems

16 Tech Circle
Natick MA 01760-1029 Thermo LabSystems [397706]
Phone: (508) 655-7010 St Georges Court
Fax: (508) 653-6999 Hanover Business Park
E-mail: precisionsystems@msn.com Altrincham, Cheshire WA14 5TP
Internet: England
http://www.nbizz.com/precisionsystemsinc Phone: 44 (161) 9423000
Fax: 44 (161) 9423001
E-mail: info@thermolabsystems.com
Internet: http://www.thermolabsystems.com
RAL
Thermo LabSystems GmbH
RAL A Thermo Electron Co [392050]
Technica para el Laboratorio SA [290005] Berner Strasse 53
Avenida Virgen de Montserrat 51 D-60437 Frankfurt am Main
E-08970 Sant Juan Despi (Barcelona) Germany
Spain Phone: 49 (69) 50919680
Phone: 34 (93) 4808047 Fax: 49 (69) 50919698
Fax: 34 (93) 3730092 E-mail: labsystems.de@thermobio.com
E-mail: ral@globainet.es Internet: http://www.labsystems.fi
Thermo LabSystems Inc [385361] Vital Scientific NV

100 Cummings Center Suite 407J A Novitron International Co [162920]
Beverly MA 01915 van Rensselaerweg 4
Phone: (978) 524-1400, (888) 888-8173 NL-6956 AV Spankeren/Dieren
Fax: (978) 524-1100 The Netherlands
E-mail: info-us@thermolabsystems.com Phone: 31 (313) 430500
Internet: http://www.thermolabsystems.com Fax: 31 (313) 427807
E-mail: info@vitalscientific.com
Thermo LabSystems Oy
Internet: http://www.vitalscientific.com
A Thermo Electron Co [384476]
Sorvaajankatu 15
Posti Loaero 208 About the chart specifications
FIN-00881 Helsinki The following terms are used in the chart:
Finland Programmed tests: The number of test methods perma-
Phone: 358 (9) 329100 nently programmed into the instrument.
Fax: 358 (9) 32910312
E-mail: hilkka.sarapisto@lifesciences.com Open test modes: Modes available for programming
Internet: http://www.labsystems.fi operator-selected tests.
Basic chemistries, special chemistries, drug assays: Tests
Transasia listed for each analyzer are specified by the manu-
facturer. Depending on where the device is mar-
Erba Diagnostics Mannheim GmbH [408735] keted, some units may provide more tests than are
Freidrichsring 4 listed; ECRI recommends contacting the supplier
D-68161 Mannheim for a complete test menu. Tests in development are
Germany based on the manufacturer’s best estimates of that
Phone: 49 (621) 1780960 procedure’s availability.
Fax: 49 (621) 1780969
European sales office Reagent substitution: Availability of reagents from
other manufacturers.
Transasia Biomedicals Ltd [332076]
Transasia House Direct sampling: A blood-drawing tube can be placed
8 Chandivali Studio Road Anderi (E) directly on the analyzer, and bar codes are used to
Mumbia 400 072 identify the sample.
India Levey-Jennings: A QC chart allowing device users to
Phone: 91 (22) 8575050 qualify statistical deviations as random or systematic.
Fax: 91 (22) 8573030 Abbreviations:
E-mail: webmaster@tbm.net
Internet: http://tbm.net AAG — α-1-acid glycoprotein
AAT — α-1-antitrypsin
UDI
ALP — Alkaline phosphatase
United Diagnostics Industry (UDI) [363522]
PO Box 26793 ALT — Alanine transaminase (also called ALAT or
Riyadh 11496 SGPT — serum glutamate pyruvate transami-
Saudi Arabia nase)
Phone: 966 (1) 4730833
E-mail: usdisal@soil.net.sa ASO — Antistreptolysin O
AST — Aspartate transaminase (also called ASAT
Vital or SGOT — serum glutamate oxaloacetate tran-
Novitron International Inc [296825] saminase)
One Gateway Center Suite 411 BUN — Blood urea nitrogen
Newton MA 02458
Phone: (617) 527-9933 C3, C4 — Complement proteins
Fax: (617) 527-8230 Ca
++
— Calcium
E-mail: info@novitronintl.com
Internet: http://www.novitronintl.com CE mark — Conformite Europeene mark
CK — Creatine kinase (also known as CPK) LDL, LD-P — Low-density lipoprotein

CK-MB — Creatine kinase MB isoenzyme LH — Luteinizing hormone
CK-NAC — Creatinine N-acetylcysteine Li — Lithium
-
Cl — Chloride LSD — Lysergic acid diethylamide
CLIA — Clinical Laboratory Improvement Amend- MDD — Medical Devices Directive
ments of 1988
Mg — Magnesium
CO2 — Carbon dioxide
+
Na — Sodium
CRP — C-reactive protein
NAPA — N-acetyl procainamide
CRT — Cathode ray tube
P-5-P — Pyridoxal-5-phosphate
CSA — Canadian Standards Association
PAP — Prostatic acid phosphatase
CSF — Cerebrospinal fluid
PCP — Pentachlorophenol
DAUs — Drugs of abuse, urine
PCR — Polymerase chain reaction
EIA — Enzyme immunoassay
PSA — Prostate-specific antigen
ELISA — Enzyme-linked immunosorbent assay
QC — Quality control
FDA — U.S. Food and Drug Administration
RF — Rheumatoid factor
FP — Fluorescence polarization
FSH — Follicle-stimulating hormone SVGA — Super Video Graphics Array
FT4 — Free (unbound) thyroxine T3 — Triiodothyronine
GGT — Gamma-glutamyltransferase T4 — Thyroxine
GLDH — Gamma-lactate dehydrogenase TCA — Tetracyclic antidepressant
HbA1c — Hemoglobin A1c TDM — Therapeutic drug monitoring
HBDH — Alpha-hydroxybutyrate dehydrogenase THC — Tetrahydrocannabinol
HBS-Ag — Hepatitis B surface antigen TIBC — Total iron binding capacity
HCG — Human chorionic gonadotropin TSH — Thyroid-stimulating hormone
HDL — High-density lipoprotein TU — Thyroid uptake
IEC — International Electrotechnical Commission UIBC — Unbound iron binding capacity

IgA — Immunoglobulin A UL — Underwriters Laboratories
IgG — Immunoglobulin G UPS — Uninterruptible power supply
IgM — Immunoglobulin M VGA — Video Graphics Array
ISE — Ion-specific electrode Note: The data in the charts derive from suppli-
+ ers’ specifications and have not been verified through
K — Potassium
independent testing by ECRI or any other agency.
LAP — Leucine aminopeptidase Because test methods vary, different products’ specifi-
cations are not always comparable. Moreover, prod-
LCD — Liquid crystal display ucts and specifications are subject to frequent changes.
LDH — Lactate dehydrogenase ECRI is not responsible for the quality or validity of
the information presented or for any adverse conse-
LDH-1, LD-1 — Lactate dehydrogenase isoenzyme quences of acting on such information.
When reading the charts, keep in mind that, unless comparison among models. However, keep in mind
otherwise noted, the list price does not reflect supplier that exchange rates change often.
discounts. And although we try to indicate which
features and characteristics are standard and which Need to know more?
are not, some may be optional, at additional cost.
For further information about the contents of this
For those models whose prices were supplied to us Product Comparison, contact the HPCS Hotline at +1
in currencies other than U.S. dollars, we have also (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or
listed the conversion to U.S. dollars to facilitate hpcs@ecri.org (e-mail).
About ECRI . . .
ECRI is a nonprofit health services research agency and a Collaborating Center of the World Health
Organization, providing information and technical assistance to the healthcare community to support
safe and cost-effective patient care for more than 25 years. The results of ECRI’s research and
experience are available through its publications, information systems, databases, technical assis-
tance program, laboratory services, seminars, and fellowships.
Our full-time staff includes a wide range of specialists in healthcare technology, hospital admini-
stration, financial analysis, risk management, and information and computer science, as well as
hospital planners, attorneys, physicists; biomedical, electrical, electronic, chemical, mechanical, and
registered engineers; physicians; basic medical scientists; epidemiologists and biostatisticians; and
writers, editors, and communications specialists.
Underlying ECRI’s knowledge base in healthcare technology are its integrity and objectivity. ECRI
accepts no financial support from medical product manufacturers, and no employee may own stock
in or consult for a medical equipment or pharmaceutical company.
The scope of ECRI’s resources extends far beyond technology. ECRI keeps healthcare professionals,
manufacturers, legal professionals, information specialists, and others aware of the changing trends
in healthcare, healthcare standards and regulations, and the best ways to handle environmental and
occupational health and safety issues. ECRI also advises on management issues related to healthcare
cost containment, accreditation, risk management, human resources, quality of care, and other
complex topics.
ECRI has more than 35 publications, databases, software, and services to fulfill the growing need
for healthcare information and decision support. They focus on three primary areas: healthcare
technology, healthcare risk and quality management, and healthcare environmental management.
Product Comparison Chart

MODEL ABBOTT ALFA WASSERMANN ALFA WASSERMANN AUDIT
Aeroset * ACE NExCT Sapphire
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes No
CE MARK (MDD) Not specified Yes Yes Yes
CONFIGURATION Floor Benchtop Benchtop Benchtop
PROGRAMMED TESTS 100 200 200 100

USER-DEFINABLE TESTS Yes (up to 100) All All Yes
OPTICAL SYSTEM Photometric Spectrophotometric, Spectrophotometric, Photometric,
bichromatic, bichromatic, bichromatic
turbidimetric turbidimetric
ASSAY METHODS End point, ISE, End point, kinetic, End point, kinetic, End point, ISE,
rate, turbidometric delta, potentiome- delta kinetic
tric (direct ISE)
BASIC/TIME, min
Albumin Yes Yes Yes Yes
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
Amylase Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
Ca++ Yes Yes Yes Yes
Cholesterol Yes Yes Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes No Yes
CO2 Yes Yes Yes Yes
Creatinine Yes Yes Yes Yes
Direct and total
bilirubin Yes Yes Yes Yes
Glucose Yes Yes Yes Yes
Inorgan phosphorus Yes Yes Yes Yes
Iron Yes Yes Yes Yes
K+ Yes Yes No Yes
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ Yes Yes No Yes
Total protein Yes Yes Yes Yes
Triglycerides Yes Yes Yes Yes
Urea Yes Yes Yes Yes
Uric acid Yes Yes Yes Yes
Others TIBC Direct LDL, direct Direct LDL, direct Ammonia, TIBC, LDL
HDL HDL
SPECIAL/TIME, min
Acid phosphatase Yes No No Yes
Ethanol No Yes Yes Yes
Aldolase No No No No
C3 Yes No No No
C4 Yes No No No
Cholinesterase Yes No No Yes
CK-MB Yes Yes Yes Yes
CSF protein Yes User defined User defined Yes
GGT Yes Yes Yes Yes
HDL cholesterol Yes Yes Yes Yes
IgA Yes Yes Yes Yes
Colons separate data on similar models of a device. This is the first of

* Model listed currently marketed; specifications current as of August 2001. three pages covering
the above model(s).
These specifications
continue onto the
next two pages.

IgG Yes Yes Yes Yes

IgM Yes Yes Yes Yes
P-5-P No No No No
T4 No Yes Yes No
TU No Yes Yes No
Urine protein Yes User defined User defined Yes
Others Lipase, neonatal Cortisol, special Cortisol, special HBDH, lipase,
bilirubin proteins, fructosa- proteins, fructosa- neonatal bilirubin
mine, transferrin, mine, transferrin,
B12, folate, lipase B12, folate, lipase
DRUG ASSAY/TIME, min

Amphetamine No Yes Yes Yes
Barbiturate No Yes Yes Yes
Benzodiazepine No Yes Yes Yes
Cannabinoid No Yes Yes Yes
Cocaine metabolite No Yes Yes Yes
Digoxin No Yes Yes Yes
Gentamicin No No No Yes
Lidocaine No No No Yes
Methadone No No No Yes
Methaqualone No ** No No Yes
Opiate No Yes Yes Yes
Phenobarbitol Yes Yes Yes Yes
Phenytoin No Yes Yes Yes
Salicylate No Yes Yes Yes
Theophylline Yes Yes Yes Yes
Others Carbamazepine Acetaminophen, val- Acetaminophen, val- Acetaminophen,
proic acid, proic acid, tobramycin
carbamazepine, carbamazepine,
phencyclidine phencyclidine
SAMPLE TYPE
Serum and plasma Yes Yes Yes Yes
Urine Yes Yes Yes Yes
CSF Yes Yes Yes Yes
SAMPLE TRAY CAPACITY 231 150 150 78
SAMPLE SIZE/RANGE µL 2-35, 0.1 increments 3-500 3-500 3-75

MAXIMUM RESULTS/hr 2,000 160, excluding ISE 160 500
THROUGHPUT,
20 test profiles/hr Up to 100 Profile dependent Profile dependent 280
REAGENT TYPE Liquid, ready to use Liquid Liquid Liquid
REAGENT DELIVERY Automatic Automatic with level Automatic with level Automatic
sensing sensing
REAGENT SUBSTITUTION Yes No No Yes
REAGENT PREPARATION On 2 assays No No No
AUTO DILUTION Yes Yes Yes Yes
AUTO QUALITY CONTROL Yes Yes Yes Yes
Colons separate data on similar models of a device. This is the second of

** In development. the above model(s).
continue onto the
next page.

AUTO VERIFICATION Not specified Not specified Not specified Not specified
AUTO CALIBRATION Yes Yes Yes Yes
CALIBRATION FREQ Varies Test dependent, up Test dependent, up 2 weeks
to 30 days to 30 days
POWER FAILURE
CALIBRATION MEMORY Yes Yes Yes Yes
ABNORMAL VALUES FLAG Yes Yes Yes Yes
DIRECT SAMPLING Yes Closed tube Closed tube Yes
WATER REQUIREMENTS,
L/min Up to 0.75 None None 0.03
Onboard supply Yes NA NA Yes
DISPLAY CRT, printer Color CRT, 8.5 x 11" CRT, 8.5 x 11" CRT, printer
report printer report printer
LIGHT SOURCE Tungsten-halogen Xenon flash tube Xenon flash tube Tungsten-halogen
COMPUTER INTERFACE RS232C Bidirectional RS232C Bidirectional RS232C RS232C
PREVENTIVE MAINT
FREQUENCY 3/year 1/year 1/year 4/year
H x W x D, cm (in) 111 x 189 x 112 40 x 69 x 57 61 x 69 x 65.5 42 x 65 x 100
(43.7 x 74.4 x 44.1) (15.8 x 27.2 x 22.5) (24 x 27.2 x 25.8) (16.5 x 25.6 x 39.4)
WEIGHT, kg (lb) 679.8 (1,499) 68 (150) 54 (119) 65 (143.3)
LINE POWER, VAC 220 115/220 115/220 220/110

POWER CONSUMPTION 3 kVA 120 W/hr 350 W maximum 300 W
PURCHASE INFORMATION
List price,
std configuration $345,000 $64,900 $37,400 Not specified
Warranty 1 year 1 year 1 year 1 year

Delivery time, ARO 2-4 weeks 30 days 30 days 4 weeks
Year first sold 1998 1993 1998 1994
Number sold >200 in USA Not specified Not specified Not specified
OTHER SPECIFICATIONS Carousel sampler; Closed primary tube Closed primary tube Windows 95 operating
ICT-ISE methodology sampling; STAT in- sampling; STAT in- software; onboard
good for 15,000 sam- terrupt; onboard re- terrupt; multipoint refrigeration,
ples or 45,000 agent refrigeration; calibration; laundry/washing of
tests; no ISE main- multipoint calibra- reagent/sample cuvettes.
tenance. tion; reagent/sample level sense; random
level sense; random access; multilevel
access; multilevel passwords; online
passwords; online help; multitasking
help; multitasking computer; self-diag-
computer; self-diagnostics; up to 4 re-
nostics; up to 4 reagent additions per
agent additions per test; no water/drain
test; no water/drain hookup; offline data
hookup; offline data storage; onboard
storage; onboard data management with
data management with QC stats; Levey-
QC stats; Levey- Jennings charts and
Jennings charts and Westgard rules. **
Westgard rules. **
Colons separate data on similar models of a device.

* Model listed currently marketed; specifications current as of August 2001.
** CLIA compliance software; ISE module and bar-code reader optional. Meets requirements of CSA.

MODEL AUDIT AUDIT BAYER BECKMAN COULTER
Sapphire 240 Sapphire 400 ADVIA 1650 * Synchron CX3 Delta *

FDA CLEARANCE No No Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Benchtop Benchtop Random access, Floor
benchtop
USER-DEFINABLE TESTS Yes Yes 62 No
OPTICAL SYSTEM Photometric Photometric Photometric, Photometric,
solid-state ISE bichromatic
ASSAY METHODS End point, kinetic End point, ISE, End point, kinetic, End point, rate,
kinetic rate indirect ISE
BASIC/TIME, min
Albumin Yes Yes Yes No
ALP Yes Yes Yes No
ALT Yes Yes Yes No
Amylase Yes Yes Yes No
AST Yes Yes Yes No
BUN Yes Yes Yes Yes
Ca++ Yes Yes Yes ISE
Cholesterol Yes Yes Yes No
CK Yes Yes Yes No
Cl- Yes Yes Yes Yes
CO2 Yes Yes Yes Yes
Direct and total
bilirubin Yes Yes Yes No
Inorgan phosphorus Yes Yes Yes No
Iron Yes Yes Yes No
K+ Yes Yes Yes Yes
LDH Yes Yes Yes No
Mg Yes Yes Yes No
Na+ Yes Yes Yes Yes
Triglycerides Yes Yes Yes No
Urea Yes Yes Yes No
Uric acid Yes Yes Yes No
Others Ammonia, TIBC, LDL Ammonia, TIBC, LDL See footnote ** None specified
SPECIAL/TIME, min
Acid phosphatase Yes Yes Yes No
Ethanol Yes Yes Yes No
Aldolase Yes Yes Yes No
Amylase Yes Yes Yes No
C3 Yes Yes Yes No
C4 Yes Yes Yes No
Cholinesterase Yes Yes Yes No
CK-MB Yes Yes No No
CSF protein Yes Yes No Yes
GGT Yes Yes Yes No
HDL cholesterol Yes Yes Yes No
IgA Yes Yes Yes No

** UIBC; convenience applications available for other tests but may not be supported by tech assistance center. the above model(s).
continue onto the
next two pages.

IgG Yes Yes Yes No

IgM Yes Yes Yes No
P-5-P Yes Yes No No
T4 Yes Yes Yes No
TU Yes Yes Yes No
Urine protein Yes Yes Yes No
Others HBDH, lipase, HBDH, lipase, Apolipoprotein A-1 None
neonatal bilirubin, neonatal bilirubin, and B, HBDH (avail-
HbA1c, RF, LD-1 HbA1c, RF, LD-1 able outside USA),
Mg; microgenics
applications for
thyroid tests

Amphetamine Yes Yes Yes No
Barbiturate Yes Yes Yes No
Benzodiazepine Yes Yes Yes No
Cannabinoid Yes Yes Yes No
Cocaine metabolite Yes Yes Yes No
Digoxin Yes Yes Yes No
Gentamicin Yes Yes Yes No
Lidocaine Yes Yes Yes No
Methadone Yes Yes Yes No
Methaqualone Yes Yes Yes No
Opiate Yes Yes Yes No
Phenobarbitol Yes Yes Yes No
Phenytoin Yes Yes Yes No
Salicylate Yes Yes Yes No
Theophylline Yes Yes Yes No
Others Acetaminophen, Acetaminophen, Syva applications None specified
tobramycin tobramycin for TDM and DAUs;
microgenics for
digoxin
SAMPLE TYPE
CSF Yes Yes Yes Yes
SAMPLE TRAY CAPACITY 55 55 84 42 (uses centrifug-
able sectors)
SAMPLE SIZE/RANGE µL 2-30 2-30 2-30 10-30; 62 for ISE

MAXIMUM RESULTS/hr 240 400 1,200 photometric, 675
450 ISE
THROUGHPUT,
20 test profiles/hr Not specified Not specified 3 sec/sample Not specified
REAGENT TYPE Liquid Liquid Liquid Liquid
REAGENT DELIVERY Automatic Automatic Automatic Automatic
REAGENT SUBSTITUTION Yes Yes Yes Yes

REAGENT PREPARATION No No Yes No
AUTO DILUTION Yes Yes Yes ORDAC **
AUTO QUALITY CONTROL Yes Yes Yes No

** ORDAC is an automatic overrange detection and correction system. the above model(s).
continue onto the
next page.

AUTO VERIFICATION Not specified Not specified Not specified Yes, with DataLink
AUTO CALIBRATION Yes Yes Yes No
CALIBRATION FREQ 2-4 weeks 2-4 weeks Test dependent 24 hr, 7 days
(total protein)
POWER FAILURE
CALIBRATION MEMORY Yes Yes Calibration, patient Yes
DIRECT SAMPLING Yes Yes Yes Yes
WATER REQUIREMENTS,
L/min 0.05 0.05 25 L/hr Not specified
Onboard supply Yes Yes Yes No
DISPLAY PC PC CRT, Epson printer CRT, printer
LIGHT SOURCE Halogen Halogen Tungsten-halogen Source lamp
COMPUTER INTERFACE RS232C RS232C Bidirectional RS232C Bidirectional

RS232C, host query
PREVENTIVE MAINT
H x W x D, cm (in) 65.7 x 53 x 48.5 80 x 64 x 52 148 x 86.7 x 112.9 176 x 69 x 77
(25.9 x 20.9 x 19.1) (31.5 x 25.2 x 20.5) (58.3 x 34.1 x 44.4) (69.3 x 27 x 30.3)
WEIGHT, kg (lb) 60 (132.3) 80 (176.6) 240 (530) 159 (350)
LINE POWER, VAC 100/240 100/240 110/220 120/240

POWER CONSUMPTION Not specified Not specified Not specified Not specified
List price,
std configuration Not specified Not specified $289,000 $66,900
Warranty Not specified Not specified 1 year 1 year

Delivery time, ARO 2 weeks 2 weeks Not specified Not specified
Year first sold 1999 2001 2000 1994
Number sold Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS Automation onboard; Automation onboard; Primary tube Host query and on-
cuvette cleaning; cuvette cleaning; sampling; 50 x 2- board primary tube
reagent cooling at reagent cooling at position reagent sampling and posi-
10°C; 2 reagent 10°C; 2 reagent tray with bar-coded tive sample ID (bar-
probes; 1 sample probes; 1 sample reagent vials; code labeling); con-
probe; air mixing; probe; air mixing; 17,000 results tinuous-loading cap-
bar-coded system bar-coded system stored; stat mode; ability; stat and
reagents; primary reagents; primary collated patient self-check diagnos-
tubes; Windows 98; tubes; Windows 98; reports; online QC tics; sample
12 wavelengths 12 wavelengths with Levey-Jennings size/range for CSF
(340-800 nm). (340-800 nm). charts. protein is 80 µL;
Cl- analysis on
sweat samples;
extended glucose and
BUN range through
ORDAC. **

** ORDAC is an automatic overrange detection and correction system.

MODEL BECKMAN COULTER BECKMAN COULTER BECKMAN COULTER BIOTECNICA
Synchron CX4 PRO : Synchron CX9 PRO * Synchron LX20 : ARCO-PC

CX5 PRO * Synchron LX20 PRO *
FDA CLEARANCE Yes Yes Yes No
CONFIGURATION Floor Floor Floor Benchtop
PROGRAMMED TESTS 96 : 100 Beckman ** 100 Beckman ** 100 Beckman ** 48

USER-DEFINABLE TESTS Yes Yes Yes Yes
OPTICAL SYSTEM Spectrophotometric, Spectrophotometric, Spectrophotometric, Photometric,
turbidimetric, polychromatic, polychromatic, colorimetric
polychromatic turbidimetric turbidimetric
ASSAY METHODS End point, rate, End point, rate, End point, rate, End point, kinetic,
indirect ISE indirect ISE indirect ISE rate, fixed time
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
Ca++ Yes Yes ISE Yes
CK Yes Yes Yes Yes
Cl- No : Yes Yes Yes Yes
CO2 No : Yes Yes Yes No
Direct and total
K+ No : Yes Yes Yes No
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ No : Yes Yes Yes No
Others IBCT, direct HDL, IBCT, direct HDL, IBCT, direct HDL, Copper, lipase
lipase lipase lipase
SPECIAL/TIME, min
Acid phosphatase No No No Yes
Ethanol Yes Yes Yes Yes
C3 No No No Yes
C4 No No No Yes
Cholinesterase Yes Yes Yes Yes
CSF protein Yes Yes Yes Yes
GGT Yes Yes Yes Yes
IgA Yes Yes Yes Yes

** Can store parameters for up to 100 Beckman-supported tests and 100 user-defined assays simultaneously. the above model(s).
continue onto the
next two pages.


IgG Yes Yes Yes Yes
IgM Yes Yes Yes Yes
P-5-P No No No No
T4 Yes Yes Yes No
TU Yes Yes Yes No
Others Ammonia, ASO, CRP, Ammonia, ASO, CRP, Ammonia, ASO, CRP, None specified
lactate, LAP, Mg, lactate, LAP, Mg, lactate, LAP, Mg,
transferrin, RF, transferrin, RF, transferrin, RF,
HbA1c, MA, PAB HbA1c, MA, PAB HbA1c, MA, PAB,
APOA, APOB

Lidocaine No No No No
Others Phencyclidine, pro- Phencyclidine, pro- Phencyclidine, pro- None
poxyphene, tobra- poxyphene, tobra- poxyphene, tobra-
mycin, valproic mycin, valproic mycin, valproic
acid, acetaminophen, acid, acetaminophen, acid, acetaminophen,
carbamazepine, carbamazepine, carbamazepine,
vancomycin vancomycin vancomycin
SAMPLE TYPE
CSF Yes Yes Yes No
SAMPLE TRAY CAPACITY 63 continuous load- 63 continuous load- 140 continuous load- 45
ing using centri- ing using centri- ing using centri-
fugable sectors fugable sectors fugable sectors
SAMPLE SIZE/RANGE µL 3-25; 62 for ISE 3-25; 62 for ISE 2-25; 62 for ISE 3-100
MAXIMUM RESULTS/hr 225 : 600 900 1,440 120
THROUGHPUT,
20 test profiles/hr Not specified Not specified Not specified 75

REAGENT PREPARATION No No No Yes
AUTO DILUTION ORDAC ** ORDAC ** Yes : ORDAC ** Yes
AUTO QUALITY CONTROL No No No Yes

** ORDAC is an automatic overrange detection and correction system. the above model(s).
continue onto the
next page.


AUTO VERIFICATION Yes, with DataLink Yes, with DataLink Yes, with DataLink Not specified
AUTO CALIBRATION No No No Yes
CALIBRATION FREQ See footnote ** See footnote ** See footnote ** Test dependent
POWER FAILURE
WATER REQUIREMENTS,
L/min Not specified Not specified 0.6 0.01
Onboard supply Not specified Not specified Not specified Yes
DISPLAY Flat-panel LCD Flat-panel LCD Flat-panel LCD CRT, printer
monitor, printer monitor, printer monitor, printer
LIGHT SOURCE Pulsed xenon lamp Pulsed xenon lamp Pulsed xenon lamp Tungsten-halogen
COMPUTER INTERFACE Bidirectional Bidirectional Bidirectional Bidirectional RS232C

RS232C, host query RS232C, host query RS232C, host query
PREVENTIVE MAINT
FREQUENCY 1/year : 2/year 2/year 3/year 2/year
H x W x D, cm (in) 175 x 119 x 76 175 x 188 x 76 152 x 177 x 104 56 x 83 x 50
(68.9 x 47 x 30) (68.9 x 74 x 30) (59.8 x 69.7 x 40.9) (22 x 32.7 x 19.7)
WEIGHT, kg (lb) 356 (785) 515 (1,135) 735 (1,620) 30 (66.1)
LINE POWER, VAC 200-240 200-240 200-240 200-240, 110

POWER CONSUMPTION Not specified Not specified Not specified 200 W
List price,
std configuration $139,000 : $159,700 $190,600 $274,500 $25,000

Delivery time, ARO Not specified Not specified Not specified 30 days
Year first sold 2001 2001 1997 : 2001 1992
Number sold Not specified Not specified Not specified 300
OTHER SPECIFICATIONS Onboard reagent See CX3 Delta and Clot detection; Automated profile
refrigeration; CX4 PRO (CX9 PRO closed-tube and workload;
reagent bar coding; combines the sampling; serum automated curve
stat load; liquid- features of these indices; automation storage; self-
level sensing probes models); DL 2000 ready; fiberoptics; diagnostics;
for reagents and data manager smart modules; integrated IBM-
samples; 80 connectivity. multiple wavelength compatible computer
nondisposable glass blanking; DL 2000 for data management.
cuvettes with data manager con- Meets
2-year warranty; nectivity; requirements of
onboard cuvette Synchron LX20 PRO IEC 601-1.
washer; primary tube has near infrared
sampling; positive particle immunoassay
patient ID with (NIPIA) detection
bar-code label; system.
DL 2000 data manager
connectivity;
ORDAC on selected
chemistries. ***

** Generally, the calibration frequency is up to every 2 weeks (variable upon chemistry test) with up to a 90-day within-lot
calibration frequency; electrolytes are every 24 hr.
*** ORDAC is an automatic overrange detection and correction system.

MODEL BIOTECNICA BIOTECNICA BIOTECNICA BIOTECNICA
BT 2245 TARGA BT 2000 TARGA BT 3000 TARGA PLUS

FDA CLEARANCE Yes No Yes No
CONFIGURATION Benchtop Benchtop Benchtop Benchtop
PROGRAMMED TESTS 48 180, programmable 160, programmable 500

OPTICAL SYSTEM Photometric, Photometric, Photometric, Photometric,
colorimetric bichromatic, bichromatic, bichromatic,
turbidimetric turbidimetric turbidimetric
ASSAY METHODS End point, kinetic, End point, kinetic, End point, kinetic, End point, kinetic,
rate, fixed time rate, fixed time rate, fixed time, rate, fixed time,
ISE ISE
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes Yes Yes
CO2 No No Yes Yes
Direct and total
K+ No No Yes Yes
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ No No Yes Yes
Others Copper, lipase Copper, lipase, Copper, lipase, Copper, lipase,
fructosamine, ASO, fructosamine, ASO, fructosamine, ASO,
PCR PCR PCR
SPECIAL/TIME, min
Acid phosphatase Yes Yes Yes Yes
Aldolase No Yes Yes Yes
C3 Yes Yes Yes Yes
C4 Yes Yes Yes Yes
CSF protein No Yes Yes Yes
GGT Yes Yes Yes Yes
IgA Yes Yes Yes Yes

three pages covering
the above model(s).
continue onto the
next two pages.

IgG Yes Yes Yes Yes

IgM Yes Yes Yes Yes
P-5-P No No No Yes
T4 No No No Yes
TU No No No Yes
Urine protein No Yes Yes Yes
Others HBDH RF RF RF

Amphetamine No No Yes Yes
Barbiturate No No Yes Yes
Benzodiazepine No No Yes Yes
Cannabinoid No No Yes Yes
Cocaine metabolite No No Yes Yes
Digoxin No No No Yes
Ethanol No No Yes Yes
Gentamicin No No No No
Methadone No No Yes Yes
Methaqualone No No Yes Yes
Opiate No No Yes Yes
Phenobarbitol No No Yes Yes
Phenytoin No No Yes Yes
Salicylate No No No Yes
Theophylline No No Yes Yes
Others None None Phencyclidine (PCP), Phencyclidine (PCP),
propoxyphene propoxyphene
SAMPLE TYPE
CSF No No No No
SAMPLE SIZE/RANGE µL 3-100 3-300 3-300 1-100

MAXIMUM RESULTS/hr 110 250 480 with ISE 500 with ISE
THROUGHPUT,
20 test profiles/hr 70 250 480 with ISE 500 with ISE

REAGENT PREPARATION Yes No No Yes
AUTO DILUTION No Yes Yes Yes

the above model(s).
continue onto the
next page.

AUTO VERIFICATION Not specified Not specified Not specified Yes

CALIBRATION FREQ Test dependent Test dependent Test dependent Test dependent
POWER FAILURE
WATER REQUIREMENTS,
L/min 0.01 0.05 0.05 0.05
Onboard supply Yes Yes Yes Yes
DISPLAY CRT, forms printer CRT, forms printer Color CRT, forms LCD color STF,
printer 12.1" VGA
LIGHT SOURCE Tungsten-halogen Dichroic lamp Dichroic lamp Dichroic lamp
COMPUTER INTERFACE Bidirectional RS232C Bidirectional RS232C Bidirectional RS232C Bidirectional RS232C
PREVENTIVE MAINT
(18.5 x 22.8 x 20.9) (17.7 x 39.4 x 19.7) (17.7 x 39.4 x 19.7) (26.8 x 39.4 x 22.4)
WEIGHT, kg (lb) 34 (75) 70 (154.3) 70 (154.3) 75 (163.3)
LINE POWER, VAC 200-240, 110 200-240, 110 200-240, 110 200-240, 110
POWER CONSUMPTION 200 W 350 W 450 W 450 W
List price,
std configuration $22,000 $45,000 $65,000 $75,000

Delivery time, ARO 30 days 30 days 30 days 180 days
Year first sold 1990 1994 1994 1999
Number sold 600 800 300 Not specified
OTHER SPECIFICATIONS Automated profile Data management; Integrated ISE and Integrated ISE and
and workload; 850 MB hard disk; data management; 850 data management; 2
automated curve stat load; liquid- MB hard disk; cooled GB hard disk; cooled
storage. Meets level sensing probes reagents; positive reagents; positive
requirements of for reagent and sam- sample ID and re- sample ID and re-
IEC 601-1. ples; primary tube agent bar coding; agent bar coding;
samples; nondispo- stat load; liquid- stat load; liquid-
sable glass cuvette; level sensing probes level sensing probes
onboard cuvette for reagent and sam- for reagent and sam-
washer; chartable ples; primary tube ples; primary tube
report; online QC; samples; nondispo- samples; nondispo-
automated profile, sable glass cuvette; sable glass cuvette;
random access, in- onboard cuvette onboard cuvette
telligent rerun washer; chartable washer; chartable
dilution; self-diag- report; online QC; report; online QC;
nostics; battery automated profile, automated profile,
backup. Meets random access, in- random access, in-
requirements of IEC telligent rerun di- telligent rerun di-
601-1. lution; self-diag- lution; self-diag-
nostics; battery nostics; battery
backup. * backup; Windows 98
software. *

* Meets requirements of IEC 601-1.

MODEL CGA DADE BEHRING DADE BEHRING DADE BEHRING
EOS 890 Plus aca Star * Dimension AR * Dimension RxL *

FDA CLEARANCE Yes Yes Yes Yes
CONFIGURATION Benchtop Floor Floor Floor
USER-DEFINABLE TESTS Yes No Yes Yes
OPTICAL SYSTEM Photometric Photometric, Photometric, Photometric,
bichromatic, bi/polychromatic, bi/polychromatic,
turbidimetric turbidimetric turbidimetric
ASSAY METHODS End point, kinetic End point, rate End point, ISE, End point, ISE,
kinetic, rate kinetic, rate, het-
erogeneous immuno
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes Yes Yes
CO2 Yes Yes Yes Yes
Direct and total
K+ Yes Yes Yes Yes
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ Yes Yes Yes Yes
Urea Yes No No Yes
Others Ammonia, TIBC, LDL, TIBC, ammonia TIBC BUN, TIBC, NPT-HDL
turbidimetric meth-
ods
SPECIAL/TIME, min
Aldolase Yes No No No
C3 Yes No No No
C4 Yes No No No
Cholinesterase Yes No No No
GGT Yes Yes Yes Yes
IgA Yes Yes No No

the above model(s).
continue onto the
next two pages.

IgG Yes Yes No No

IgM Yes Yes No No
P-5-P Yes No No No
T4 Yes Yes Yes Yes
TU Yes Yes Yes Yes
Urine protein Yes Yes Yes Yes
Others HBDH, lipase, LD-1, neonatal Alcohol, ammonia, Alcohol, ammonia,
neonatal bilirubin, bilirubin, liver CRP, lipase, lac- CRP, lipase, lac-
RF, LD-1 lactic dehydrogen- tate, pseudocholin- tate, pseudocholin-
ase, glutamyltrans- esterase esterase, prealbumin
ferase, pseudochol-
inesterase, CRP,
ferritin, FSH, LH **
Amphetamine No Urine Urine Urine
Barbiturate No Urine, serum Urine Urine
Benzodiazepine No Urine, serum Urine Urine
Cannabinoid No Urine Urine Urine
Cocaine metabolite No Urine Urine Urine
Digoxin No Urine Yes Yes
Gentamicin No Yes Yes Yes
Lidocaine No Yes No No
Methadone No Urine Urine Urine
Methaqualone No No No No
Opiate No Urine Yes Urine
Phenobarbitol No Yes Yes Yes
Theophylline No Yes Yes Yes
Others None Amikacin, carbamaze- Carbamazepine, phen- Carbamazepine, phen-
pine, digitoxin, cyclidine (urine), cyclidine (urine),
ethosuximide, metho- tobramycin, valproic tobramycin, valproic
trexate, NAPA, prim- acid, vancomycin acid, vancomycin,
idone, procainamide *** acetaminophen
SAMPLE TYPE
CSF Yes Yes Yes Yes

MAXIMUM RESULTS/hr 120 100 540, photometric and 500 photometric,
ISE 288 electrolyte
THROUGHPUT,
20 test profiles/hr 75 95 19 500, 260
REAGENT TYPE Liquid Liquid, tablet Liquid, tablet Liquid, tablet
REAGENT DELIVERY Automatic Test pack Automatic, FLEX Automatic, FLEX

cartridge cartridge
REAGENT SUBSTITUTION Yes No Yes Yes
REAGENT PREPARATION Yes No No No
AUTO QUALITY CONTROL Yes Onboard QC Onboard QC Onboard QC

** Also lipase, TSH, ATIII, heparin, B2M, and digoxin. the above model(s).
*** Also quinidine, tobramycin, valproic acid, vancomycin, acetaminophen, serum tricyclic antidepressants, and urine PCP. These specifications
continue onto the
next page.

AUTO VERIFICATION Yes Not specified Not specified Not specified

AUTO CALIBRATION Yes No Yes Yes
CALIBRATION FREQ 2 weeks 2-4/year 4/year 4/year
POWER FAILURE
CALIBRATION MEMORY Yes Yes UPS UPS
DIRECT SAMPLING No Yes Yes Yes
WATER REQUIREMENTS,
L/min Not specified Not specified 0.03-0.07 0.03-0.07
DISPLAY Printer Thermal printer, Thermal printer, Thermal printer,
color CRT ** color CRT ** color CRT
LIGHT SOURCE Tungsten-halogen Tungsten-halogen Tungsten-halogen Tungsten-halogen
COMPUTER INTERFACE RS232C Bidirectional RS232C, data RS232C, data

RS232C, data manager manager manager
PREVENTIVE MAINT
H x W x D, cm (in) 91.4 x 170.2 x 216 127 x 140 x 82.5 127 x 112 x 77 112 x 158.7 x 77
(36 x 67 x 85) (50 x 55 x 32.5) (50 x 44 x 30.5) (44 x 62.5 x 30.5)
WEIGHT, kg (lb) 47 (103.6) 323 (710) 272 (600) 340 (750)
LINE POWER, VAC 110/220 115/230, 50/60 Hz 115/230, 50/60 Hz 115/230, 50/60 Hz
POWER CONSUMPTION 500 W Not specified Not specified Not specified
List price,
std configuration $10,500 Not specified Not specified Not specified

Delivery time, ARO 6 weeks 60 days 30 days 60 days
Year first sold 1995 1995 1992 1995
Number sold 480 Not specified 1,000 375
OTHER SPECIFICATIONS Meets requirements Direct tube User-defined, Same as Dimension AR
of ISO 9002. sampling; query method-specific plus auto
capability; onboard autodilution; auto reagent loading/un-
QC; random-access rerun w/o technolo- loading; onboard
drug, specialty, and gist intervention; urine dilution; mod-
stat system; no onboard QC; contin- ular design; reflex-
reagent preparation; uous inventory moni- ive testing; track
minimum maintenance; tor; 1-button daily interface; auto-
walkaway operation; maintenance; 2 dif- serum; autoflagging
bar-code sample ID; ferent reagent lots of out-of-range QC
sealed pack with can be stored on- values; with HM
reagent and patient board at once; re- module additional
sample disposed of agent can be added basic chemistries
automatically in a while processing; available: HCG, TSH,
biowaste receptacle. stores 44 different FT4, PSA, CTnI,
FLEX cartridges MCK-MB, myoglobin,
simultaneously; ran- and ferritin.
dom-access profile
and stat system auto
reagent prep; walk-
away operation;
query capability.

** An optional 8.5 x 11" report printer is available.

MODEL ELAN DIAGNOSTICS ELAN DIAGNOSTICS HYCEL HYCEL
ATAC 6000 ATAC 8000 Lisa 300 Plus Lisa 500 Plus
WHERE MARKETED USA USA Worldwide Worldwide

FDA CLEARANCE Yes Yes Not specified Not specified
CONFIGURATION Benchtop Benchtop Filter photometer Filter photometer

OPTICAL SYSTEM Photometric, Photometric, Colorimetric, ISE Colorimetric, ISE
bichromatic bichromatic
ASSAY METHODS EIA, end point, EIA, end point, ISE, End point, kinetic, End point, kinetic
kinetic, rate, fixed kinetic, rate, fixed ISE optional direct potentio-
time, sample BLK time, sample BLK metric, ISE
BASIC/TIME, min
Albumin Yes Yes 3 3
ALP Yes Yes 5 5
ALT Yes Yes 5 5
Amylase Yes Yes 7 7
AST Yes Yes 5 5
BUN Yes Yes 3 3
Ca++ Yes Yes 5 5
Cholesterol Yes Yes 12 12
CK Yes Yes 7 7
Cl- Yes Yes 1 1
CO2 Yes Yes 5 5
Creatinine Yes Yes 5 5
Direct and total
bilirubin Yes Yes 7 7
Glucose Yes Yes 10 10
Inorgan phosphorus Yes Yes 5 5
Iron Yes Yes 7 7
K+ Yes Yes 1 1
LDH Yes Yes 5 5
Mg Yes Yes 5 5
Na+ Yes Yes 1 1
Total protein Yes Yes 3 3
Triglycerides Yes Yes 10 10
Urea Yes Yes 3 3
Uric acid Yes Yes 5 5
Others TIBC TIBC, microalbumin, TIBC TIBC
albumin, micropro-
tein
SPECIAL/TIME, min
Acid phosphatase Yes Yes 7 7
Ethanol No No 7 7
Aldolase No No 10 10
Amylase Yes Yes 10 10
C3 No No 5 5
C4 No No 5 5
Cholinesterase No No 10 10
CK-MB Yes Yes 5 5
CSF protein No No 7 7
GGT Yes Yes 7 7
HDL cholesterol Yes Yes 10 10
IgA No No 7 7

the above model(s).
continue onto the
next two pages.

IgG No No Yes Yes

IgM No No Yes Yes
P-5-P No No Not specified Not specified
T4 No No No No
TU No No No No
Others Apolipoprotein A-1 Apolipoprotein A-1 None specified None specified
and B, fructosamine, and B, fructosamine,
glycohemoglobin, LD-1, D-HDL, D-LDL
PAP, PSA, TSH, LD-1

Amphetamine No No 10 10
Barbiturate No No 10 10
Benzodiazepine No No 10 10
Cannabinoid No No 10 10
Cocaine metabolite No No 10 10
Digoxin No No 10 10
Ethanol No No 10 10
Gentamicin No No 10 10
Lidocaine No No 10 10
Methadone No No 10 10
Methaqualone No No 10 10
Opiate No No 10 10
Phenobarbitol No No 10 10
Phenytoin No No 10 10
Salicylate No No 10 10
Theophylline No No 10 10
Others None specified None specified None specified None specified
SAMPLE TYPE
CSF No Yes Yes Yes

MAXIMUM RESULTS/hr 110 475 150 + ISE 180 + ISE
THROUGHPUT,
20 test profiles/hr Not specified 18 8.3 10

REAGENT PREPARATION Yes No With exceptions With exceptions
AUTO QUALITY CONTROL Yes Yes Online Online

the above model(s).
continue onto the
next page.

AUTO VERIFICATION Not specified Yes Not specified Not specified

CALIBRATION FREQ Test dependent Test dependent Reagent dependent Reagent dependent
POWER FAILURE
DIRECT SAMPLING No Yes Yes Yes
WATER REQUIREMENTS,
L/min Not specified 0.02 0.006 L/min 0.007 L/min
Onboard supply Yes Yes ~21-day supply 20-day supply
DISPLAY CRT, printer CRT, printer Color screen, Color screen,
printer printer
LIGHT SOURCE Halogen Halogen Halogen Halogen
COMPUTER INTERFACE Bidirectional RS232 Bidirectional RS232 Bidirectional RS232C Bidirectional RS232C
PREVENTIVE MAINT
FREQUENCY 4/year Cycle dependent 1/year 1/year
H x W x D, cm (in) 47 x 58 x 53 47 x 99.1 x 52.1 190 x 307 x 183 190 x 307 x 183
(18.5 x 23 x 21) (18.5 x 39 x 20.5) (74.8 x 120.8 x 72) (74.8 x 120.8 x 72)
WEIGHT, kg (lb) 34 (75) 70.3 (155) 86 (189.6) 86 (189.6)
LINE POWER, VAC 110 110 110/220, 50/60 Hz 110/220, 50/60 Hz

POWER CONSUMPTION Not specified Not specified 500 VA 500 VA
List price,
std configuration Not specified Not specified Not specified Not specified

Delivery time, ARO 1 week 1 week Not specified Not specified
Year first sold 1991 1995 1996 1996
OTHER SPECIFICATIONS Automated profile Random-access and None specified. None specified.
and workload stat testing; posi-
analyzer with stat- tive sample ID; 4-
interrupt ability; parameter integrated
automated curve ISEs; Westgard
storage and data rules; ability to
reduction for interface with other
EIA testing; lab instruments;
GHbA1c program; lab- laboratory informa-
oratory information tion system
system included. included.

MODEL INSTRUMENTATION INSTRUMENTATION INSTRUMENTATION JEOL
ILAB 600 * ILAB 900 * ILAB 1800 * BM1250 *
WHERE MARKETED Worldwide Worldwide Worldwide Japanese market

FDA CLEARANCE Submitted Yes Yes Not specified
CONFIGURATION Floor Floor Floor Floor

OPTICAL SYSTEM Spectrophotometric, Spectrophotometric, Spectrophotometric, Photometric, ISE
mono/bi/trichromatic mono/bi/trichromatic mono/bi/trichromatic
ASSAY METHODS End point, ISE, End point, End point, ISE, End point, reaction
kinetic kinetic, rate kinetic, rate rate
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes Yes Yes
CO2 Yes Yes Yes No
Direct and total
K+ Yes Yes Yes Yes
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ Yes Yes Yes Yes
Urea Urea nitrogen Urea nitrogen Urea nitrogen Yes
Others Acid phosphatase, Acid phosphatase, Acid phosphatase, Ammonia, UIBC, LDL
CK-MB, lipase, TIBC CK-MB, lipase, TIBC CK-MB, lipase, TIBC
SPECIAL/TIME, min
Aldolase No No No Yes
C3 Yes Yes Yes Yes
C4 Yes Yes Yes Yes
CSF protein Yes Yes Yes No
GGT Yes Yes Yes Yes
IgA Yes Yes Yes Yes

the above model(s).
continue onto the
next two pages.

ILAB 600 * ILAB 900 * ILAB 1800 * BM1250 *
IgG Yes Yes Yes Yes

IgM Yes Yes Yes Yes
P-5-P Yes Yes Yes No
T4 Yes Yes Yes Yes
TU Yes Yes Yes No
Others ASO, CRP, RF ASO, CRP, RF ASO, CRP, RF HbA1c, lipase,
C-reactive protein,
HBS-Ag, rheumatoid
factor, apolipo-
protein A-1 and B

Digoxin Yes Yes Yes Yes
Phenytoin Yes Yes Yes Yes
Others Carbamazepine, Carbamazepine, Carbamazepine, Carbamazepine,
phencyclidine phencyclidine phencyclidine valproic acid
SAMPLE TYPE
CSF Yes Yes Yes Not specified

MAXIMUM RESULTS/hr 400 photometric, 600 photometric, 1,200 photometric, Not specified
400 ISE plus 450 with ISE plus 450 with ISE
THROUGHPUT,
20 test profiles/hr 24 35 65 1,250
REAGENT DELIVERY Direct pickup Direct pickup Direct pickup Automatic

REAGENT PREPARATION Limited Limited Limited Yes
AUTO DILUTION Yes Yes Yes Into dilution tray

the above model(s).
continue onto the
next page.

ILAB 600 * ILAB 900 * ILAB 1800 * BM1250 *
CALIBRATION FREQ Test dependent Test dependent Test dependent Not specified
POWER FAILURE
WATER REQUIREMENTS,
L/min 0.3 0.3 0.5 0.41
DISPLAY Color CRT, printer Color CRT, printer Color CRT, printer CRT, printer
LIGHT SOURCE Tungsten-halogen Tungsten-halogen Tungsten-halogen Halogen
COMPUTER INTERFACE Bidirectional RS232 Bidirectional RS232C Bidirectional RS232C RS232C
PREVENTIVE MAINT
H x W x D, cm (in) 118 x 98 x 76 118 x 152 x 101.5 118 x 223 x 101.5 116 x 148 x 93
(46.5 x 38.6 x 29.9) (46.5 x 59.8 x 40) (46.5 x 87.8 x 40) (45.7 x 58.3 x 36.6)
WEIGHT, kg (lb) 300 (661.5) 550 (1,212.5) 850 (1,873.9) 600 (1,322.8)
LINE POWER, VAC 110/230 117/220 117/220 100-230

POWER CONSUMPTION 2 kVA Not specified Not specified 3 kVA
List price,
std configuration Not specified $185,000 $280,000 Not specified

Delivery time, ARO 45 days 1 month 1 month Not specified
Year first sold Not specified 1993 1993 1997
Number sold Not specified Not specified Not specified 100
OTHER SPECIFICATIONS Primary tube Primary tube Primary tube Predilution micro
sampling; random- sampling; random- sampling; random- volume technology;
access profile and access profile and access profile and 2, 3, 4.5 sec cycle
stat system; sample/ stat system; sample/ stat system; sample/ time. Meets
reagent bar-code ID; reagent bar-code ID; reagent bar-code ID; requirements of
onboard reagent onboard reagent onboard reagent CSA and UL.
refrigeration; non- refrigeration; non- refrigeration; non-
linear data re- linear data re- linear data re-
duction; online duction; online duction; online
real-time QC; auto real-time QC; auto real-time QC; auto
start-up and start-up and start-up and
shutdown; automatic shutdown; automatic shutdown; automatic
daily maintenance; daily maintenance; daily maintenance;
rerun and reflexive rerun and reflexive rerun and reflexive
testing program. testing program; testing program.
upgradable to ILAB
1800.


MODEL JEOL JEOL KDK LSI
BM1650 * BM2250 * Spotchem, SP-4430 AGII Chemistry

Analyzer
WHERE MARKETED Japanese market Japanese market Worldwide ** Worldwide
FDA CLEARANCE Not specified Not specified Not specified Yes
CE MARK (MDD) Yes Yes Yes Submitted
CONFIGURATION Floor Floor Benchtop Benchtop
PROGRAMMED TESTS 103 103 22 65+

USER-DEFINABLE TESTS Yes Yes No Yes
OPTICAL SYSTEM Photometric, ISE Photometric, ISE Photometric Autofilter photo-
meter, interference
filters, bichromatic
ASSAY METHODS End point, reaction End point, reaction End point, reaction End point, kinetic,
rate rate rate initial rate,
bichromatic
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes No Yes
CO2 No No No Yes
Direct and total
bilirubin Yes Yes Total Yes
Iron Yes Yes No Yes
K+ Yes Yes No No
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ Yes Yes No No
Others Ammonia, UIBC, LDL Ammonia, UIBC, LDL Hemoglobin LDL
SPECIAL/TIME, min
Acid phosphatase Yes Yes No Yes
Ethanol No No No No
Aldolase Yes Yes No No
C3 Yes Yes No No
C4 Yes Yes No No
Cholinesterase Yes Yes No No
CK-MB Yes Yes No CK, yes; MB, no
CSF protein No No No No
GGT Yes Yes Yes Yes
HDL cholesterol Yes Yes Direct method Yes
IgA Yes Yes No No

** Except Canada and USA. the above model(s).
continue onto the
next two pages.


Analyzer
IgG Yes Yes No No
IgM Yes Yes No No
P-5-P No No No No
T4 Yes Yes No No
TU No No No No
Urine protein Yes Yes No No
Others HbA1c, lipase, HbA1c, lipase, Fructosamine Lipase
C-reactive protein, C-reactive protein,
HBS-Ag, rheumatoid HBcAg, rheumatoid
factor, apolipo- factor, apolipo-
protein A-1 and B protein A-1 and B

Amphetamine No No No No
Barbiturate No No No No
Benzodiazepine No No No No
Cannabinoid No No No No
Cocaine metabolite No No No No
Digoxin Yes Yes No No
Ethanol No No No No
Gentamicin No No No No
Methadone No No No No
Methaqualone No No No No
Opiate No No No No
Phenobarbitol Yes Yes No No
Phenytoin Yes Yes No No
Salicylate No No No No
Theophylline Yes Yes No No
Others Carbamazepine, Carbamazepine, None specified None specified
valproic acid valproic acid
SAMPLE TYPE
Serum and plasma Yes Yes Yes Serum
Urine Yes Yes No No
CSF Not specified Not specified No No
SAMPLE SIZE/RANGE µL 2-30 2-30 ~5 2-25

MAXIMUM RESULTS/hr Not specified Not specified 63 220-260
THROUGHPUT,
20 test profiles/hr 1,650 2,250 63 12-13
REAGENT TYPE Liquid Liquid Dry Liquid, powder
REAGENT DELIVERY Automatic Automatic Manual Automatic

REAGENT PREPARATION Yes Yes No Yes
AUTO DILUTION Into dilution tray Into dilution tray No No
AUTO QUALITY CONTROL Yes Yes No Yes

the above model(s).
continue onto the
next page.


Analyzer
AUTO VERIFICATION Not specified Not specified Yes Not specified
CALIBRATION FREQ Not specified Not specified Every new lot Automatic daily
POWER FAILURE
DIRECT SAMPLING Yes Yes Yes No
WATER REQUIREMENTS,
L/min 0.41 0.5 None 0.0007
Onboard supply Yes Yes NA Yes
DISPLAY CRT, printer CRT, printer LCD PC monitor, printer
LIGHT SOURCE Halogen Halogen LED Quartz-halogen
COMPUTER INTERFACE RS232C RS232C RS232C RS232C
PREVENTIVE MAINT
FREQUENCY 2/year 2/year 1/year Not specified
H x W x D, cm (in) 116 x 148 x 93 116 x 170 x 93 16 x 20 x 33 61 x 61 x 35.6
(45.7 x 58.3 x 36.6) (45.7 x 66.9 x 36.6) (6.3 x 7.9 x 13) (24 x 24 x 14)
WEIGHT, kg (lb) 600 (1,322.8) 650 (1,433) <5 (<11) 29.5 (65)
LINE POWER, VAC 100-230 100-230 100-240 90-264

POWER CONSUMPTION 3 kVA 3 kVA 50 W 625 W
List price,
std configuration Not specified Not specified Not specified $28,000; $31,527
with ISE unit
Warranty 1 year 1 year Not specified 1 year
Delivery time, ARO Not specified Not specified Not specified 4-6 weeks
Year first sold 1997 1999 2000 1997
Number sold 150 10 Not specified 320
OTHER SPECIFICATIONS Predilution micro- Predilution micro- Centrifuge installed Reusable cuvettes;
volume technology; volume technology; on-site; organ- random access;
2, 3, 4.5 sec cycle 2, 3, 4.5 sec cycle specific reagents. batch; stats;
time. Meets time. Meets ISE interface
requirements of requirements of included.
CSA and UL. CSA and UL.


MODEL METROLAB OLYMPUS OLYMPUS OLYMPUS
2300 : 2300 Plus AU400e AU640e AU2700

CONFIGURATION Benchtop Floor Floor Floor
PROGRAMMED TESTS Unlimited 99 99 99

bichromatic bichromatic bichromatic bichromatic
immunoassay, coagu- ISE ISE ISE
lation time, ISE *
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
Amylase Yes Urine Urine Urine
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
Ca++ Yes Urine Urine Urine
CK Yes Yes Yes Yes
Cl- Yes Urine Urine Urine
CO2 Yes Yes Yes Yes
Creatinine Yes Urine Urine Urine
Direct and total
Glucose Yes Urine Urine Urine
Inorgan phosphorus Yes Urine Urine Urine
K+ Yes Urine Urine Urine
LDH Yes Yes Yes Yes
Mg Yes Urine Urine Urine
Na+ No Urine Urine Urine
Total protein Yes Urine Urine Urine
Urea Yes Urine Urine Urine
Uric acid Yes Urine Urine Yes
Others None specified Lipase, UIBC, Lipase, UIBC, Lipase, UIBC,
ammonia, lactate, ammonia, lactate, ammonia, lactate,
direct HDL, direct direct HDL, direct direct HDL, direct
LDL LDL LDL
SPECIAL/TIME, min
Aldolase Yes No No No
C3 Yes Yes Yes Yes
C4 Yes Yes Yes Yes
Cholinesterase Yes No No No
GGT Yes Yes Yes Yes
IgA Yes Yes Yes Yes

* Also turbidimetric. three pages covering
the above model(s).
continue onto the
next two pages.

2300 : 2300 Plus AU400e AU640e AU2700
IgG Yes Yes Yes Yes

IgM Yes Yes Yes Yes
P-5-P Yes No No No
T4 Yes Yes Yes Yes
TU Yes Yes Yes Yes
Others None specified AAG, AAT ASO, AAG, AAT ASO, AAG, AAT ASO,
apolipoprotein, A-1 apolipoprotein, A-1 apolipoprotein, A-1
and B, beta-2-micro- and B, beta-2-micro- and B, beta-2-micro-
globulin, CRP, globulin, CRP, globulin, CRP,
ceruloplasmin, ceruloplasmin, ceruloplasmin,
ferritin, hapto- ferritin, hapto- ferritin, hapto-
globin, microalbumin * globin, microalbumin * globin, microalbumin *
Amphetamine No Yes Yes Yes
Barbiturate No Yes Yes Yes
Benzodiazepine No Yes Yes Yes
Cannabinoid No Yes Yes Yes
Cocaine metabolite No Yes Yes Yes
Digoxin No Yes Yes Yes
Gentamicin No Yes Yes Yes
Lidocaine No Yes Yes Yes
Methadone No Yes Yes Yes
Methaqualone No Yes Yes Yes
Opiate No Yes Yes Yes
Phenobarbitol No Yes Yes Yes
Theophylline No Yes Yes Yes
Others None specified THC, LSD, PCP, TCA, THC, LSD, PCP, TCA, THC, LSD, PCP, TCA,
acetaminophen, NAPA, acetaminophen, NAPA, acetaminophen, NAPA,
propoxyphene, propoxyphene, propoxyphene,
caffeine, amikacin, caffeine, amikacin, caffeine, amikacin,
carbamazepine ** carbamazepine ** carbamazepine **
SAMPLE TYPE
CSF Yes Yes Yes Yes

MAXIMUM RESULTS/hr 250 800 1,200 2,133
THROUGHPUT,
20 test profiles/hr Not specified 20 samples 45 samples 89 samples
REAGENT DELIVERY Automatic, level Automatic pipetting Automatic pipetting Automatic pipetting
detection
REAGENT PREPARATION No No No No

* Also prealbumin, RF, transferrin, HbA1c, and high-sensitivity CRP. three pages covering
** Also disopyramide, ethosuximide, methotrexate, primidone, procainamide, quinidine, tobramycin, valproic acid, and vancomycin. the above model(s).
continue onto the
next page.

2300 : 2300 Plus AU400e AU640e AU2700
AUTO VERIFICATION Yes Not specified Not specified Not specified

CALIBRATION FREQ Test dependent Test dependent Test dependent Test dependent
POWER FAILURE
WATER REQUIREMENTS,
L/min 0.002 : 1.5/500 test 0.43 0.67 1.1
DISPLAY Video, SVGA, color CRT, printer CRT, printer CRT, printer
printer
COMPUTER INTERFACE Bidirectional RS232C RS232C RS232C RS232C
PREVENTIVE MAINT
H x W x D, cm (in) 40 x 81 x 54 121.9 x 144.8 x 76.2 127 x 188 x 81 126 x 200 x 114
(15.7 x 31.9 x 21.3) (48 x 57 x 30) (50 x 74 x 31.9) (49.6 x 78.7 x 44.9)
WEIGHT, kg (lb) 40 (88.2) 419 (924) 530 (1,168.4) 700 (1,543.2)
LINE POWER, VAC 115/220 220 220 220

POWER CONSUMPTION 300 W 3,500 VA 4,000 VA 6,000 VA
List price,
std configuration $20,000 : $25,000 $130,000 $185,000 $320,000

Delivery time, ARO 4 weeks Immediately Immediately Not specified
Year first sold 1999 1998 1999 2000
Number sold 600 Not specified Not specified Not specified
OTHER SPECIFICATIONS Westgard rules; Automatic Automatic Automatic
language selection; repeat, dilution, repeat, dilution, repeat, dilution,
multitasking; reflex testing; CLIA reflex testing; CLIA reflex testing; CLIA
Windows; washing software package; software package; software package;
cuvette station; Windows NT software; Windows NT software; Windows NT software;
cooled reagents; online help program online help program online help program
optional ISE, sample & maintenance video; & maintenance video; and maintenance
bar code, ELISA. 122-test menu; 122-test menu; video; 122-test
liquid, ready-to-use liquid, ready-to-use menu; liquid,
bar-coded reagent bar-coded reagent ready-to-use bar-
cartridges; 6-month cartridges; 6-month coded reagent
ISE guarantee; cont ISE guarantee; cartridges; 6-month
sample rack feed & continuous sample ISE guarantee;
STAT compartment; rack feed and STAT continuous sample
probe crash protec- compartment; probe rack feed and STAT
tion and clot crash protection and compartment; probe
detection; modem clot detection; crash protection and
support. * modem support. * clot detection;
modem support. *

* Compatible with OLA 1500 lab automation sorter, decapper, and sample archiving system; additional assay including pH,
nitrates, and specific gravity.

MODEL OLYMPUS OLYMPUS ORTHO-CLINICAL ORTHO-CLINICAL
DIAGNOSTICS DIAGNOSTICS
AU5421 with Dual ISE AU5431 with Dual ISE VITROS 250 VITROS 950

FDA CLEARANCE Submitted Submittted Yes Yes
PROGRAMMED TESTS 99 99 48+ 49+

USER-DEFINABLE TESTS Yes Yes No No
bichromatic bichromatic colorimetric, colorimetric,
potentiometric potentiometric
ISE ISE rate, 2-point rate, rate, 2-point rate,
immuno rate immuno rate
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
Amylase Urine Urine Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
Ca++ Urine Urine Yes Yes
CK Yes Yes Yes Yes
Cl- Urine Urine Yes Yes
CO2 Yes Yes Yes Yes
Creatinine Urine Urine Yes Yes
Direct and total
bilirubin Yes Yes Yes (also indirect) Yes (also indirect)
Glucose Urine Urine Yes Yes
Inorgan phosphorus Urine Urine Yes Yes
K+ Urine Urine Yes Yes
LDH Yes Yes Yes Yes
Mg Urine Urine Yes Yes
Na+ Urine Urine Yes Yes
Total protein Urine Urine Yes Yes
Urea Urine Urine Yes Yes
Others Lipase, UIBC, Lipase, UIBC, TIBC TIBC
ammonia, lactate, ammonia, lactate,
direct HDL, direct direct HDL, direct
LDL LDL
SPECIAL/TIME, min
Acid phosphatase Yes Yes No Yes
C3 Yes Yes No No
C4 Yes Yes No No
Cholinesterase No No Yes Yes
GGT Yes Yes Yes Yes
IgA Yes Yes No No

the above model(s).
continue onto the
next two pages.

IgG Yes Yes No No

IgM Yes Yes No No
P-5-P No No No No
T4 Yes Yes No No
TU Yes Yes No No
Others AAG, AAT, ASO, AAG, AAT, ASO, Ammonia, lactate, Ammonia, CRP,
apolipoprotein, A-1 apolipoprotein, A-1 lipase, Mg, CRP lactate, lipase, Mg
and B, beta-2-micro- and B, beta-2-micro-
globulin, CRP, globulin, CRP,
ceruloplasmin, ceruloplasmin,
ferritin, hapto- ferritin, hapto-
globin, microalbumin * globin, microalbumin *
Amphetamine Yes Yes No No
Barbiturate Yes Yes No No
Benzodiazepine Yes Yes No No
Cannabinoid Yes Yes No No
Cocaine metabolite Yes Yes No No
Gentamicin Yes Yes No No
Lidocaine Yes Yes No No
Methadone Yes Yes No No
Methaqualone Yes Yes No No
Opiate Yes Yes No No
Salicylate Yes Yes Yes Yes
Others THC, LSD, PCP, TCA, THC, LSD, PCP, TCA, Acetaminophen, Acetaminophen, Li
acetaminophen, NAPA, acetaminophen, NAPA, Li
propoxyphene, propoxyphene,
caffeine, amikacin, caffeine, amikacin,
carbamazepine ** carbamazepine **
SAMPLE TYPE
CSF Yes Yes Yes Yes

MAXIMUM RESULTS/hr 5,000 6,600 250 900
THROUGHPUT,
20 test profiles/hr 178 samples 267 samples Not specified Not specified
REAGENT TYPE Liquid Liquid MicroSlide Dry chemistry slides
REAGENT DELIVERY Automatic pipetting Automatic pipetting Automatic MicroSlide
REAGENT SUBSTITUTION Yes Yes No No

REAGENT PREPARATION No No None required None required
AUTO DILUTION Yes Yes Yes No

* Also prealbumin, RF, transferrin, HbA1c, and high-sensitivity CRP. three pages covering
** Also disopyramide, ethosuximide, methotrexate, primidone, procainamide, quinidine, tobramycin, valproic acid, and vancomycin. the above model(s).
continue onto the
next page.

AUTO CALIBRATION Yes Yes No No
CALIBRATION FREQ Test dependent Test dependent 6 months 6 months
POWER FAILURE
WATER REQUIREMENTS,
L/min 2.0 3.0 None None
Onboard supply Yes Yes NA NA
DISPLAY CRT, printer CRT, printer CRT, forms printer CRT, forms printer
COMPUTER INTERFACE RS232C RS232C Bidirectional RS232C Bidirectional RS232C
PREVENTIVE MAINT
H x W x D, cm (in) 126 x 377 x 114 126 x 507 x 114 119 x 114 x 71 140 x 173 x 96.5
(49.6 x 148 x 44.9) (49.6 x 200 x 44.9) (47 x 44.9 x 28) (55 x 68 x 38)
WEIGHT, kg (lb) 1,370 (3,021) 1,780 (3,916) 272 (600) 681 (1,500)
LINE POWER, VAC 220 220 115/120 196-220

POWER CONSUMPTION 10,000 VA 12,000 VA Not specified Not specified
List price,

Delivery time, ARO Not specified Not specified Not specified Not specified
Year first sold 2001 2001 Not specified Not specified
OTHER SPECIFICATIONS Compatible with Compatible with Automatic cartridge QC package; zero-
Olympus OLA 1500 lab Olympus OLA 1500 lab loading; inventory maintenance ISEs;
automation sorter/ automation sorter/ management; STAT unlimited derived
decapper/sample decapper/sample interrupt; HELP tests; periodic
archiving system; archiving system; text; can dilute any electronic mainten-
automatic repeat run automatic repeat run sample from a 1:20 ance logs;
option; automatic option; automatic ratio; accepts all full menu available
dilution and reflex dilution and reflex tube sizes; full onboard simultan-
testing; CLIA soft- testing; CLIA soft- menu available eously; disposable
ware package; ware package; onboard simultan- probe tip; sample/
Windows NT software; Windows NT software; eously; disposable reagent level
online help program online help program probe tip; sample/ sensing; clot
and maintenance and maintenance reagent level detection.
videos; 122-test videos; 122-test sensing; clot
menu; liquid ready- menu; liquid ready- detection.
to-use reagent to-use reagent
cartridges; 6-month cartridges; 6-month
ISE guarantee. * ISE guarantee. *

* Probe crash protection and clot detection; single- and dual-flowcell ISE modules; refrigerated QC loader; multilot advanced
calibration; reagent inventory; dry-bath incubation; nondisposable cuvettes; automatic start-up, secondary printer.

MODEL PRECISION SYSTEMS RAL RAL ROCHE DIAGNOSTICS
FAILED TO RESPOND *
Analette Clima MC-15 Medicheck QC-18 912

FDA CLEARANCE Yes No No Yes
CE MARK (MDD) No Yes Yes Not specified
CONFIGURATION Benchtop Benchtop Benchtop Floor

OPTICAL SYSTEM Photometric, Photometric, mono Photometric, mono Photometric,
bichromatic and bichromatic and bichromatic colorimetric
ASSAY METHODS End point, ISE, End point, kinetic, End point, kinetic, End point, kinetic,
kinetic rate FxT ratio, FxT ratio, double kinetic,
differential, MSTD differential, MSTD turbidimetric, ISE
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes Yes Yes
CO2 Yes Yes Yes Yes
Direct and total
K+ Yes Yes Yes Yes
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ Yes Yes Yes Yes
Others Ammonia, TIBC, LDL Yes Yes Direct HDL, direct
LDL, lactate,
lipase, UIBC
SPECIAL/TIME, min
Acid phosphatase Yes Yes Yes No
C3 Yes Yes Yes Yes
C4 Yes Yes Yes Yes
GGT Yes Yes Yes Yes
IgA Yes Yes Yes Yes

* Specifications current as of August 2001. three pages covering
the above model(s).
continue onto the
next two pages.

FAILED TO RESPOND *
IgG Yes Yes Yes Yes

IgM Yes Yes Yes Yes
T4 Yes Yes Yes Yes
TU Yes Yes Yes Yes
Others HBDH, lipase, None specified None specified Alpha-1-antitrypsin,
neonatal bilirubin, ammonia, B12, CRP,
HbA1c, RF, LD-1 fructosamine, hapto-
globin, microalbu-
min, myoglobin,
rheumatoid factor,
transferrin **
Amphetamine Yes Yes Yes Yes
Barbiturate Yes Yes Yes Yes
Benzodiazepine Yes Yes Yes Yes
Cannabinoid Yes Yes Yes Yes
Cocaine metabolite Yes Yes Yes Yes
Gentamicin Yes Yes Yes Yes
Methadone Yes Yes Yes Yes
Opiate Yes Yes Yes Yes
Others Acetaminophen, None specified None specified PCP, NAPA, PROC,
tobramycin carbamazepine, val-
proic acid, LSD,
propoxyphene,
tobramycin, folic
acid
SAMPLE TYPE
CSF Yes Yes Yes Yes
SAMPLE TRAY CAPACITY 42-72 15 64 70

MAXIMUM RESULTS/hr 300 900 end point, 120 720
225 kinetics
THROUGHPUT,
20 test profiles/hr 7/8 Not specified Not specified 21
REAGENT TYPE Liquid Liquid Liquid Primarily liquid
REAGENT DELIVERY Automatic Manual Automatic Automatic
REAGENT SUBSTITUTION Not specified No On request Yes

REAGENT PREPARATION No No Yes Minimal
AUTO DILUTION No No Yes Yes

** Also p-amylase, ASLO, B2-microglobulin, ceruloplasim, ferritin, halc, ISE, RF. the above model(s).
continue onto the
next page.

FAILED TO RESPOND *
AUTO VERIFICATION No Yes Not specified Not specified

AUTO CALIBRATION No No No res
CALIBRATION FREQ Not specified 1 month 1 week 4 weeks
POWER FAILURE
DIRECT SAMPLING Yes No Yes Yes
WATER REQUIREMENTS,
L/min 0.005 No No 0.0083
Onboard supply No NA NA No
DISPLAY CRT, printer LCD 4 x 40 dots External CRT, printer
LIGHT SOURCE Tungsten-halogen Halogen Halogen Tungsten-halogen
COMPUTER INTERFACE RS232C RS232C RS232C Bidirectional RS232,

batch processing
PREVENTIVE MAINT
(12.2 x 27.6 x 24) (22.8 x 22.4 x 7.9) (28 x 24.4 x 14.2) (39 x 29.1 x 44.1)
WEIGHT, kg (lb) 36.3 (80) 20 (44.1) 38 (83.8) 410 (904.1)
LINE POWER, VAC 115/120 or 230 110-220 110-220 110

POWER CONSUMPTION 500 W 900 W 300 VA Not specified
List price,
std configuration $34,000 Not specified Not specified $170,000

Delivery time, ARO 4-6 weeks 60 days 60 days 4 weeks
Year first sold 1997/1998 2000 2000 1997
Number sold Not specified 153 107 Not specified
OTHER SPECIFICATIONS None specified. None specified. None specified. UL approved.

* Specifications current as of August 2001.

MODEL ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS
FAILED TO RESPOND * FAILED TO RESPOND * FAILED TO RESPOND * FAILED TO RESPOND *
Cobas Integra 400 Cobas Integra 700 Cobas Integra 800 Cobas Mira Plus CC

CE MARK (MDD) Not specified Not specified Not specified Not specified
CONFIGURATION Benchtop Floor Floor Benchtop

USER-DEFINABLE TESTS No No No Yes
OPTICAL SYSTEM FP, photometric FP, photometric FP, photometric Photometric,
colorimetric
ASSAY METHODS End point, FP, End point, FP, End point, FP, End point, kinetic,
kinetic, turbidi- kinetic, turbidi- kinetic, turbidi- turbidimetric, ISE
metric, ISE metric, ISE metric, ISE
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes Yes Yes
CO2 Yes Yes Yes Yes
Direct and total
K+ Yes Yes Yes Yes
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ Yes Yes Yes Yes
Others Direct HDL, direct Direct HDL, direct UIBC, direct HDL, Direct HDL, direct
LDL, lactate, LDL, lactate, direct LDL, lipase, LDL
lipase, micro- lipase, micro- lactate
albumin, UIBC albumin, UIBC
SPECIAL/TIME, min
C3 Yes Yes Yes Yes
C4 Yes Yes Yes Yes
Cholinesterase Yes Yes Yes No
CK-MB Yes Yes Yes No
CSF protein Yes Yes Yes No
GGT Yes Yes Yes Yes
HDL cholesterol Yes Yes Yes Direct
IgA Yes Yes Yes Yes

the above model(s).
continue onto the
next two pages.

IgG Yes Yes Yes Yes

IgM Yes Yes Yes Yes
P-5-P Yes Yes Yes Yes
T4 Yes Yes Yes Yes
TU Yes Yes Yes Yes
Others Fructosamine, anti- Fructosamine, anti- Ceruloplasmin, STfR, Apolipoprotein A-1
trypsin, antistrep- trypsin, antistrep- D-dimer, ammonia, and B, fructosamine,
tolysin O, acid tolysin O, acid fructosamine, anti- LDH-1, T3, vitamin
glycoprotein, apo- glycoprotein, apo- trypsin, antistrep- B-12, folate, HbA1c,
lipoprotein A-1 and lipoprotein A-1 and tolysin O, acid digoxin
B, CRP, haptoglobin, B, CRP, haptoglobin, glycoprotein, apoli-
transferrin, RF transferrin, RF ** poprotein, A1, B ***
Gentamicin Yes Yes Yes Yes
Methaqualone Yes Yes Yes Yes
Others See Other See Other Acetaminophen, ami- See Other
Specifications Specifications kacin, carbamaze- Specifications
pine, free pheny-
toin, valproic acid,
vancomycin, free
valproic acid, NAPA †
SAMPLE TYPE
CSF Yes Yes Yes Yes
SAMPLE TRAY CAPACITY 6 trays, 15 samples 5 trays, 30 samples 180 Up to 90 sample
per tray per tray cups, up to 32
primary tubes
MAXIMUM RESULTS/hr 460 860 855 144; 204 with ISE
THROUGHPUT,
20 test profiles/hr Not specified 35 Not specified Not specified
REAGENT TYPE Liquid Liquid Liquid Liquid/dry
reconstitute
REAGENT SUBSTITUTION No No No Yes

REAGENT PREPARATION No No No Varies
AUTO QUALITY CONTROL Yes Yes Not specified Yes

** Also cyclosporine, ceruloplasmin, D-dimer, p-amylase, STfR. the above model(s).
*** Also CRP, haptoglobin, transferrin, RF, antithrombin III, ferritin, HbA1c, HbA1c(WB), lactate, myoglobin, microalbumin, These specifications
p-Amylase, halc. continue onto the
†
Also ISE, LSD, phenycyclidine, primidone, procainamide, propoxyphene, quinidine, and tobramycin. next page.

CALIBRATION FREQ 4/year, test 4/year, test 4/year, test Test dependent;
dependent dependent dependent 30 days, minimum
POWER FAILURE
CALIBRATION MEMORY Yes Yes Yes Not specified
WATER REQUIREMENTS,
L/min 0.03 0.07 0.07 0.004
Onboard supply 1L Not specified Not specified 2.5 L
DISPLAY Color LCD, laser Color CRT, laser Color CRT, laser CRT, thermal
printer printer printer dot-matrix printer
LIGHT SOURCE Tungsten-halogen Tungsten-halogen LED Xenon flash tube
COMPUTER INTERFACE Bidirectional RS232C Bidirectional RS232C Bidirectional RS232C Bidirectional RS232
PREVENTIVE MAINT
(29.5 x 53.1 x 26) (58 x 47.2 x 33.5) (47.3 x 74.8 x 35.4) (26 x 29 x 23)
WEIGHT, kg (lb) 230 (507) 420 (925) 512 (1,126) 100 (221)
LINE POWER, VAC 115 220 220 115

POWER CONSUMPTION 1,200 VA 1,400 VA 1,700 VA Not specified
List price,
std configuration Not specified Not specified Not specified $57,286

Delivery time, ARO 4 weeks 4 weeks 4 weeks Immediately
Year first sold 1999 1995 2001 1992
Number sold >90 >330 Not specified >10,000 both Mira
OTHER SPECIFICATIONS Bar-coded reagent Bar-coded reagent Sample pipetting in- Closed primary tube
tracking; 56 tests tracking; 72 tests cludes clot and sampling; auto self-
and up to 90 appli- and up to 90 appli- level detection; diagnostics; on-
cations onboard; cations onboard; sample racks board data analysis
auto maintenance; auto maintenance; compatible with with 6 different
remote diagnostics; remote diagnostics; other Roche chemis- math models; on-
onboard refrigera- onboard refrigera- try and immunology board refrigeration;
tion; forecasting tion; forecasting systems; stat sample auto cuvette loader;
module; additional module; additional prioritization; bar- 26 customized
drug assays for ace- drug assays for ace- coded reagent track- panels; bar-code
taminophen, amika- taminophen, amika- ing; 72 tests and up reading available;
cin, carbamazepine, cin, carbamazepine, to 90 applications additional drug
free phenytoin, val- free phenytoin, val- onboard; auto main- assays for aceta-
proic acid, vanco- proic acid, vanco- tenance; remote minophen, carbamaze-
mycin, free valproic mycin, free valproic diagnostics; onboard pine, NAPA, PCP,
acid, NAPA, primi- acid, NAPA, primi- refrigeration; fore- procainamide, pro-
done, phenycycli- done, phenycycli- casting module. poxyphene, quini-
dine, procainamide, dine, procainamide, dine, and tobra-
propoxyphene, quini- propoxyphene, quini- mycin. Meets
dine, lithium (ISE), dine, lithium (ISE), requirements of CSA
tobramycin, LSD, tobramycin, LSD, and UL.
barbiturates. barbiturates.


MODEL ROCHE DIAGNOSTICS THERMO LABSYSTEMS THERMO LABSYSTEMS THERMO LABSYSTEMS
FAILED TO RESPOND *
Modular Konelab 20 : Konelab 30 : Konelab 60 :
Konelab 20i Konelab 30i Konelab 60i
FDA CLEARANCE Yes No No No
CE MARK (MDD) Not specified Yes Yes Yes
PROGRAMMED TESTS 47-149 200 200 200

colorimetric bichromatic bichromatic bichromatic
double kinetic, 2-point, direct ISE 2-point, direct ISE 2-point, direct ISE
turbidimetric, ISE
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
Ca++ Yes No Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes Yes Yes
CO2 Yes Yes Yes Yes
Direct and total
K+ Yes Yes Yes Yes
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ Yes Yes Yes Yes
Others Direct HDL, direct Li, HBDH Li, HBDH Li, HBDH
LDL, LD1, UIBC
SPECIAL/TIME, min
Acid phosphatase No Yes Yes Yes
C3 Yes Yes Yes Yes
C4 Yes Yes Yes Yes
GGT Yes Yes Yes Yes
IgA Yes Yes Yes Yes

the above model(s).
continue onto the
next two pages.

FAILED TO RESPOND *
IgG Yes Yes Yes Yes
IgM Yes Yes Yes Yes
P-5-P Yes No No No
T4 Yes No No No
TU Yes No No No
Others Alpha-1-antitrypsin, Alpha-1-antitrypsin, Alpha-1-antitrypsin, Alpha-1-antitrypsin,
ammonia, CRP, apolipoprotein A-1 apolipoprotein A-1 apolipoprotein A-1
fructosamine, hapto- and B, ASO, CRP, and B, ASO, CRP, and B, ASO, CRP,
globin, microalbu- haptoglobin, oroso- haptoglobin, oroso- haptoglobin, oroso-
min, myoglobin, mucoid, RF, trans- mucoid, RF, trans- mucoid, RF, trans-
rheumatoid factor, ferrin, microalbumin ferrin, microalbumin ferrin, microalbumin
transferrin, HbA1c in urine ** in urine ** in urine **
Digoxin Yes No No No
Gentamicin Yes No No No
Methaqualone No Yes Yes Yes
Others PCP, NAPA, PROC, Carbamazepine, pri- Carbamazepine, pri- Carbamazepine, pri-
carbamazepine, val- midone, valproic midone, valproic midone, valproic
proic acid, LSD, acid, acetaminophen, acid, acetaminophen, acid, acetaminophen,
propoxyphene cotinine, phencycli- cotinine, phencycli- cotinine, phencycli-
dine, propoxyphene, dine, propoxyphene, dine, propoxyphene,
tricyclics tricyclics tricyclics
SAMPLE TYPE
CSF Yes Yes Yes Yes
SAMPLE TRAY CAPACITY 300 90, continuous- 130, continuous- 130, continuous-
loading sample loading sample loading sample
segment segment segment
MAXIMUM RESULTS/hr 10,400 200 300; 480 with ISE 600; 780 with ISE
THROUGHPUT,
20 test profiles/hr 520 200 300 600
REAGENT TYPE Primarily liquid Liquid Liquid Liquid
REAGENT DELIVERY Automatic Automatic, bar-coded Automatic, bar-coded Automatic, bar-coded

reagents reagents reagents
REAGENT PREPARATION Minimal Method dependent Method dependent Method dependent

** Also LDL cholesterol and HbA1c. the above model(s).
continue onto the
next page.

FAILED TO RESPOND *
AUTO VERIFICATION Not specified Yes Yes Yes
CALIBRATION FREQ 4 weeks, Test dependent Test dependent Test dependent
test dependent
POWER FAILURE
CALIBRATION MEMORY Yes No Battery backup Battery backup
WATER REQUIREMENTS,
L/min Varies 0.01 0.02 0.04
DISPLAY Color CRT with True-color CRT, True-color CRT, gra- True-color CRT, gra-
touchscreen graphics printer phics printer phics printer
LIGHT SOURCE Tungsten-halogen Halogen Halogen Halogen
COMPUTER INTERFACE Bidirectional RS232 Bidirectional RS232C Bidirectional RS232C Bidirectional RS232C
PREVENTIVE MAINT
H x W x D, cm (in) Varies 130 x 85 x 79 115 x 120 x 79 115 x 150 x 79
(51.2 x 33.5 x 31.1) (45.3 x 47.2 x 31.1) (45.3 x 59 x 31.1)
WEIGHT, kg (lb) Varies 130 (287) 200 (441) 250 (551.3)
LINE POWER, VAC 220 100-240 100-230 100-240

POWER CONSUMPTION Not specified 300 : 350 W 700 VA 1,200 VA
List price,
std configuration Not specified $60,000 $85,000 $150,000

Delivery time, ARO 4 weeks 6 weeks 6 weeks 6 weeks
Year first sold 1998 1999 1998 1997
Number sold Not specified 463 475 296
OTHER SPECIFICATIONS Expandable; can 38 tests onboard; 48 tests onboard; 48 tests onboard;
integrate with pre- up to 4 reagent up to 4 reagent up to 4 reagent
analytical auto- additions/test; additions/test; additions/test;
mation and with cooled reagents and cooled reagents; cooled reagents;
immunology module in samples; real-time real-time reagent real-time reagent
future; can be reagent status status checking; status checking;
configured with 1-4 checking; external integrated bar-code integrated bar-code
modules. Additional bar-code reader for reader for samples reader for samples
special assays reagents; integrated and reagents; online and reagents; online
include ASLO, bar-code reader dilution; graphical dilution; graphical
B2-microglobulin, for samples; online user interface; op- user interface; op-
ceruloplasmin, IgE, dilution; graphical tional interface for tional interface for
lactate, p-Amylase, user interface. direct sample direct sample
prealbumin. UL dispensing from the dispensing from the
approved. conveyor. conveyor.


MODEL TRANSASIA TRANSASIA TRANSASIA UDI
ERBA SMARTLAB ERBA XL-300 ERBA XL-600 Udichem ELITE

FDA CLEARANCE Not specified Not specified Not specified Not specified
CONFIGURATION Benchtop Floor Floor Benchtop
OPTICAL SYSTEM Filter photometric, Diffraction grating Diffraction grating Photometric,
bichromatic of 12 wavelengths of 12 wavelengths bichromatic
(340-750 mm) (340-750 mm)
ASSAY METHODS End point, kinetic Rate A, rate B, 1- Rate A, rate B, 1- End point, initial
point, 2-point, point, 2-point, rate, kinetic
multipoint multipoint differential
BASIC/TIME, min
ALP Yes Yes Yes Yes
ALT Yes Yes Yes Yes
AST Yes Yes Yes Yes
BUN Yes Yes Yes Yes
CK Yes Yes Yes Yes
Cl- Yes Yes Yes Yes
CO2 Yes Yes Yes No
Direct and total
K+ Yes Yes Yes Yes
LDH Yes Yes Yes Yes
Mg Yes Yes Yes Yes
Na+ Yes Yes Yes Yes
Others Hemoglobin, UIBC, ammonia, LDL UIBC, ammonia, LDL None specified
ammonia, TIBC, LDL microalbumin, CRP microalbumin, CRP
SPECIAL/TIME, min
C3 Yes Yes Yes No
C4 Yes Yes Yes No
GGT Yes Yes Yes Yes
IgA Yes Yes Yes Yes

the above model(s).
continue onto the
next two pages.

IgG Yes Yes Yes Yes

IgM Yes Yes Yes Yes
T4 Yes Yes Yes No
TU Yes Yes Yes No
Others HBDH, lipase RF, Mg, apolipopro- RF, Mg, apolipopro- HBDH, lipase,
tein A, apolipoprotein A, apolipopro- neonatal bilirubin
tein B tein B

Others None specified None specified None specified None
SAMPLE TYPE
CSF Yes Yes Yes Yes
SAMPLE TRAY CAPACITY 45 50 x 10 trays, 25 50 x 10 trays, 25 40
stat, 8 controls stat, 8 controls

MAXIMUM RESULTS/hr 120 300 600 (360 biochemist- 200
ry and 240 ISE)
THROUGHPUT,
20 test profiles/hr Not specified Not specified Not specified 8

REAGENT PREPARATION Yes Yes No Yes

the above model(s).
continue onto the
next page.

AUTO VERIFICATION Not specified Yes Yes Not specified

AUTO CALIBRATION Yes Yes Yes No
CALIBRATION FREQ User definable User definable User definable 1 week
POWER FAILURE
WATER REQUIREMENTS,
L/min 0.03 0.1 0.1 0.001
Onboard supply No Yes Yes Yes
DISPLAY CRT, printer CRT CRT with optional CRT, printer
touchscreen
COMPUTER INTERFACE Unidirectional Bidirectional RS232C Bidirectional RS232C RS232C

RS232C
PREVENTIVE MAINT
(15 x 30.3 x 18.1) (43 x 33.1 x 24) (43 x 33.1 x 24) (29.1 x 22 x 15.7)
WEIGHT, kg (lb) 34 (75) 150 (331) max, main 150 (331) max, main 60 (132.3)
unit with monitor unit with monitor
LINE POWER, VAC 110/220 110/220 110/220 110/220 ±10%
POWER CONSUMPTION 100 W 1 kVA 1 kVA 400 W
List price,

Delivery time, ARO 4-6 weeks 4-6 weeks 4-6 weeks 4 weeks
Year first sold 1992 2001 2000 1996
Number sold >500 >20 >50 Not specified
OTHER SPECIFICATIONS Automated profile 5-stage laundry With integral ISE 50/60 ±10% Hz.
and workload; auto- system; reagent module; 5-stage
mated curve storage. refrigeration on laundry system;
board; primary tube/ reagent refriger-
sample cups ation onboard;
sampling; permanent sample and reagent
hard-glass cuvettes; bar-code facility;
LLS; VOD probe primary tube/sample
sensor; 10,000 cups sampling;
results storage; permanent hard-glass
50 positions; cuvettes; LLS; VOD
refrigerated probe sensor;
reagent carousel; 10,000 results
optional sample and storage; 50
reagent bar-code positions; refrig-
facility. erated reagent
carousel.

MODEL VITAL VITAL
Vitalab Flexor E : Vitalab Selectra XL

Vitalab Selectra E
WHERE MARKETED Worldwide Worldwide
FDA CLEARANCE Yes Yes
CE MARK (MDD) Yes Yes
CONFIGURATION Benchtop Standalone
PROGRAMMED TESTS 100 115

USER-DEFINABLE TESTS Yes Yes
OPTICAL SYSTEM Photometric, Photometric,
bichromatic bichromatic
ASSAY METHODS End point, kinetic, End point, kinetic,

2-point, ISE 2-point, ISE
BASIC/TIME, min
Albumin Yes Yes
ALP Yes Yes
ALT Yes Yes
Amylase Yes Yes
AST Yes Yes
BUN Yes Yes
Ca++ Yes Yes
Cholesterol Yes Yes
CK Yes Yes
Cl- Yes Yes
CO2 Yes Yes
Creatinine Yes Yes
Direct and total
bilirubin Yes Yes
Glucose Yes Yes
Inorgan phosphorus Yes Yes
Iron Yes Yes
K+ Yes Yes
LDH Yes Yes
Mg Yes Yes
Na+ Yes Yes
Total protein Yes Yes
Triglycerides Yes Yes
Urea Yes Yes
Uric acid Yes Yes
Others Bicarbonate, CK-NAC, Bicarbonate, CK-NAC,
lactate, LAP, lactate, LAP,
LDH(Tris), lipase, LDH(Tris), lipase,
LDL cholesterol LDL cholesterol
SPECIAL/TIME, min
Acid phosphatase Yes Yes
Ethanol Yes Yes
Aldolase Yes Yes
Amylase Yes Yes
C3 Yes Yes
C4 Yes Yes
Cholinesterase Yes Yes
CK-MB Yes Yes
CSF protein Yes Yes
GGT Yes Yes
HDL cholesterol Yes Yes
IgA Yes Yes

the above model(s).
continue onto the
next two pages.

MODEL VITAL VITAL

Vitalab Selectra E
IgG Yes Yes
IgM Yes Yes
P-5-P Yes Yes
T4 Yes Yes
TU Yes Yes
Urine protein Yes Yes
Others GLDH, HBDH, GLDH, HBDH,
prostate-specific prostate-specific
acid phosphatase, acid phosphatase,
CRP, elastase, RF CRP, elastase, RF

Amphetamine Yes Yes
Barbiturate Yes Yes
Benzodiazepine Yes Yes
Cannabinoid Yes Yes
Cocaine metabolite Yes Yes
Digoxin Yes Yes
Ethanol Yes Yes
Gentamicin Yes Yes
Lidocaine Yes Yes
Methadone Yes Yes
Methaqualone Yes Yes
Opiate Yes Yes
Phenobarbitol Yes Yes
Phenytoin Yes Yes
Salicylate Yes Yes
Theophylline Yes Yes
Others Carbamazepine, etho- Carbamazepine, etho-
suximide, phencycli- suximide, phencycli-
dine, primidone, dine, primidone,
valproic acid valproic acid
SAMPLE TYPE
Serum and plasma Yes Yes
Urine Yes Yes
CSF Yes Yes
SAMPLE TRAY CAPACITY 51 80
SAMPLE SIZE/RANGE µL 1-30 1-30

MAXIMUM RESULTS/hr 180 + ISE 460 + ISE, 360
THROUGHPUT,
20 test profiles/hr 180 + ISE 460 + ISE, 360
REAGENT TYPE Liquid Liquid
REAGENT DELIVERY Automatic Automatic
REAGENT SUBSTITUTION Yes Yes

REAGENT PREPARATION Yes Yes
AUTO DILUTION Yes Yes
AUTO QUALITY CONTROL Yes Yes

the above model(s).
continue onto the
next page.

MODEL VITAL VITAL

Vitalab Selectra E
AUTO VERIFICATION Not specified Yes
AUTO CALIBRATION Yes Yes
CALIBRATION FREQ 2 weeks 2 weeks
POWER FAILURE
CALIBRATION MEMORY Yes Yes
ABNORMAL VALUES FLAG Yes Yes
DIRECT SAMPLING Yes Yes
WATER REQUIREMENTS,
L/min Variable Variable
Onboard supply Yes Yes
DISPLAY CRT, printer CRT, printer
LIGHT SOURCE Halogen Halogen
COMPUTER INTERFACE RS232 RS232, USB
PREVENTIVE MAINT
FREQUENCY 2/year 2/year
H x W x D, cm (in) 115 x 49 x 58 117 x 115 x 77
(45.3 x 19.3 x 22) (46.1 x 45.3 x 30.3)
WEIGHT, kg (lb) 100 (220.5) 180 (394)
LINE POWER, VAC 90-240 90-240

POWER CONSUMPTION 500 W 500 W
List price,
std configuration $45,000 $75,000
Warranty 1 year 1 year

Delivery time, ARO 4 weeks 4 weeks
Year first sold 1998 2002
Number sold 5,000 NA
OTHER SPECIFICATIONS Multiple languages. Multiple languages.
Meets requirements Meets requirements
of UL. of UL and CB.

Clinical Chemistry Analyzers, Automated

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Clinical Chemistry Analyzers, Automated

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October 2002

Clinical Chemistry Analyzers, Automated,

179894 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

Principles of operation a tungsten-halogen quartz lamp; each cuvette is read

sample is aspirated from the stoppered tube and added

On other analyzer systems, once patient samples

Potentiometric analyses for Na+, K+, Cl-, and carbon

Because of the small sample volume, any interfer-

The waste generated by discrete chemistry analyz-

Purchase considerations Final regulations of the Clinical Laboratory Im-

The following represent sample five-year PV/LCC Alternative 3 — Straight Lease

• Dollar discount factor is 5.75% • Consumables = $15,000/year

Supplier information Alfa Wassermann SpA [255224]

Beckman Coulter Instruments France SA Dade Behring GmbH [329465]

Instrumentation Laboratory SpA [156052] Metrolab

Ortho-Clinical Diagnostics (England) Roche Diagnostics

Precision Systems Inc [101934] Thermo LabSystems

Thermo LabSystems Inc [385361] Vital Scientific NV

CK — Creatine kinase (also known as CPK) LDL, LD-P — Low-density lipoprotein

FT4 — Free (unbound) thyroxine T3 — Triiodothyronine

GGT — Gamma-glutamyltransferase T4 — Thyroxine

GLDH — Gamma-lactate dehydrogenase TCA — Tetracyclic antidepressant

HbA1c — Hemoglobin A1c TDM — Therapeutic drug monitoring

HBDH — Alpha-hydroxybutyrate dehydrogenase THC — Tetrahydrocannabinol

HBS-Ag — Hepatitis B surface antigen TIBC — Total iron binding capacity

HCG — Human chorionic gonadotropin TSH — Thyroid-stimulating hormone

HDL — High-density lipoprotein TU — Thyroid uptake

IEC — International Electrotechnical Commission UIBC — Unbound iron binding capacity

Product Comparison Chart

Aeroset * ACE NExCT Sapphire

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

PROGRAMMED TESTS 100 200 200 100

Colons separate data on similar models of a device. This is the first of

Product Comparison Chart

Aeroset * ACE NExCT Sapphire

IgG Yes Yes Yes Yes

DRUG ASSAY/TIME, min

SAMPLE SIZE/RANGE µL 2-35, 0.1 increments 3-500 3-500 3-75

Colons separate data on similar models of a device. This is the second of

Product Comparison Chart

Aeroset * ACE NExCT Sapphire

COMPUTER INTERFACE RS232C Bidirectional RS232C Bidirectional RS232C RS232C

WEIGHT, kg (lb) 679.8 (1,499) 68 (150) 54 (119) 65 (143.3)

LINE POWER, VAC 220 115/220 115/220 220/110

Warranty 1 year 1 year 1 year 1 year

Colons separate data on similar models of a device.

Product Comparison Chart

Sapphire 240 Sapphire 400 ADVIA 1650 * Synchron CX3 Delta *

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

Colons separate data on similar models of a device. This is the first of

Product Comparison Chart

Sapphire 240 Sapphire 400 ADVIA 1650 * Synchron CX3 Delta *

IgG Yes Yes Yes No

DRUG ASSAY/TIME, min

SAMPLE SIZE/RANGE µL 2-30 2-30 2-30 10-30; 62 for ISE

REAGENT DELIVERY Automatic Automatic Automatic Automatic

REAGENT SUBSTITUTION Yes Yes Yes Yes

Colons separate data on similar models of a device. This is the second of

Product Comparison Chart

Sapphire 240 Sapphire 400 ADVIA 1650 * Synchron CX3 Delta *

LIGHT SOURCE Halogen Halogen Tungsten-halogen Source lamp

COMPUTER INTERFACE RS232C RS232C Bidirectional RS232C Bidirectional

WEIGHT, kg (lb) 60 (132.3) 80 (176.6) 240 (530) 159 (350)

LINE POWER, VAC 100/240 100/240 110/220 120/240

PROGRAMMED TESTS 96 : 100 Beckman 100 Beckman 100 Beckman ** 48