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Point-of-Care Testing: Millennium Technology For Critical Care
Point-of-Care Testing: Millennium Technology For Critical Care
Richard F. Louie
Zuping Tang, MD
David G. Shelby, MT
Gerald J. Kost, MD, PhD
Point-of-Care Testing:
Millennium Technology
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Table 1. Characteristics of Whole-Blood Analyzers
Sample Analysis Time
Instrument Manufacturer Type Volume (mmL) (seconds) Test Analytes (measured)
i-STAT* Abbott Diagnostics, Handheld 65 or 95 90-140 pO2, pCO2, pH, Na+, K+, Ca++,
Abbott Park, IL Cl-, Hct, urea nitrogen, glucose,
lactate, creatinine
AVL OMNI †‡ AVL Scientific, Transportable 40-161 60-90 pO2, pCO2, pH, Na+, K+,
Roswell, GA Ca++, Cl-, Hct, Hb, urea nitrogen,
glucose, lactate, creatinine
AVL OPTI AVL Scientific Portable 125 <120 pO2, pCO2, pH, Na+, K+, Ca++, Cl-, Hb
Rapid Lab 800 Bayer Diagnostics, Transportable 140-175 85 pO2, pCO2, pH, Na+, K+, Ca++, Cl-,
series †
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Springs, OH
Portable indicates easily carried, usually with a built-in handle; transportable, equipment usually carried on a cart; pO2, blood oxygen tension; pCO2,
blood carbon dioxide tension; SO2%, oxygen saturation; TCO2, total carbon dioxide in blood; Na+, sodium; K+, potassium; Ca++, ionized calcium; Mg++,
magnesium; Cl-, chloride; Hct, hematocrit; Hb, hemoglobin.
* i-STAT test cluster capability is cartridge dependent.
†Co-oximetry available as a modular add-on.
‡AVL OMNI test cluster is instrument-model dependent.
§3100 includes optimal modular prothrombin time (PT), activated partial thromboplastin time (aPTT), and activated clotting time (ACT) tests.
errors.1 Some common preanalytic and postanalytic Point-of-care testing is convenient for clinicians,
errors associated with traditional laboratory testing because it can be performed quickly, and results are
are listed in Table 4. Delays in specimen processing readily available. As point-of-care test menus
4
and testing may allow samples to degrade. The sub- expand, we will find that based on real-time clinical
Section
sequent testing may yield results that do not repre- need, POCT drives diagnostic testing. Current
sent the actual status of the patient. This is especially point-of-care instruments are user friendly, which
true when blood gases, pH, and glucose are tested. allows nontechnically oriented or nonlaboratory
Performing tests immediately at the bedside mini- professionals to operate instruments. Many point-
mizes both preanalytic and postanalytic errors, of-care devices are self-contained with on-screen
because bedside testing eliminates time delays due to instructions, which promote ease of use. Several
specimen transportation and multiple persons han- point-of-care devices are low maintenance because
dling a patient specimen. Postanalytic errors can be they are self-contained, use disposable test car-
minimized because results from bedside testing are tridges, and the test cartridges are readily replaced.
immediately available to the clinical team and can be Finally, POCT is advantageous because of the
printed out or stored in memory by the instrument. small sample volume required to perform a test.
Furthermore, the results are recorded directly onto Patients potentially lose 25 to 125 mL of blood each
the patient’s chart. day, or up to 944 mL of blood per hospital stay
through phlebotomy for traditional centralized lab-
oratory testing.8-10 Oftentimes, in the OR, ICU, and
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Table 2. Characteristics of Glucose Monitoring Devices
* Systems use handheld meters and glucose test strips, except the HemoCue B-Glucose, which is a portable analyzer that uses a
cuvette and photometric absorbance to measure glucose. The SureStepPro and One Touch Hospital test strips use photometric
reflectance. Test strips for the other systems incorporate electrochemical (amperometric) biosensors for glucose measurement.
GO indicates glucose oxidase; GD, glucose dehydrogenase. Test limitations are those provided by the manufacturers and list the
recommended test conditions to yield the optimal results.
ED, there is demand for frequent serial whole-blood pose a potential problem to whole-blood biosen-
testing. Serial testing of patients with respiratory fail- sors. Although studies13,14 have documented the
ure or distress, acid-base imbalance, or surgery pro- accuracy of point-of-care test results compared with
vides useful trend monitoring, which is helpful when that of laboratory test results, the accuracy of smaller-
determining whether current therapy is effective. Serial format devices remains controversial (eg, bedside
whole-blood testing may be as frequent as every 15 to glucose testing with handheld devices). Recent stud-
30 minutes during open heart surgery. Such frequent ies4,5,15,16 have documented the potential effects of
laboratory testing results in extensive blood loss, which high or low blood oxygen tension, hematocrit, and
could lead to unwarranted transfusions as well to pH levels, which could cause handheld glucose
unforeseen health complications (eg, transfusion- meters to report higher or lower glucose values.
acquired illness, infections, and iatrogenic anemia). In Because the responsibility of POCT in critical care
the treatment of critically ill patients, minimizing is usually assigned to nonlaboratory professionals,2,17
blood loss is of utmost importance.8,11,12 Point-of-care another concern with POCT is whether measure-
instruments are capable of providing a cluster of tests ments by nonlaboratory professionals (eg, nurses,
with minimal blood loss (as low as 40 µL), depending physicians) are accurate compared to measurements
on the instrument used and the test performed. Cur- by laboratory professionals. Studies have reported
rent point-of-care instruments can provide up to 14 that measurements obtained by nonlaboratory pro-
simultaneously measured test parameters (Table 2). fessionals with the proper training can be as accurate
This strategy conserves blood and minimizes health as those obtained by laboratory professionals.14,18
complications and unnecessary transfusions.12 Measurements generally are accurate if operators
have been properly trained in quality assurance and
Disadvantages of Point-of-Care Testing instruments are properly maintained.
Table 3 summarizes some of the disadvantages of There is additional concern that nonlaboratory
POCT. A concern that arises with POCT is the accu- professionals may not have adequate understanding
racy and performance of the instrument when used or appreciation of the significance of quality control
in critical care settings. One important question is and quality assurance for testing devices.2,17 Nonlab-
whether interfering substances in the specimen can oratory professionals may not take adequate respon-
affect instrument performance. This concern is sibility for quality management and performance
especially true in critical care, where changes in enhancement, thereby potentially affecting patient
blood gases, pH, glucose, and medication levels can results. Therefore, it is important that the hospital
team (ie, physicians, nurses, medical technologists,
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Test Limitations
Linearity (mg/dL) † Chemistry Hct (%) pO2 (mmHg)
0-400 GO None None
None
20-600 GO 20-70 None
20-600 GO 20-70 None
20-600 GO 20-70 None
0-600 GO 25-60, adults None
25-65, neonates
0-600 GO 25-60, adults < 45, [Glu] > 150 mg/dL
respiratory therapists, and pathologists) know the Table 3. Advantages and Disadvantages of Point-of-Care Testing
proper operating procedures and limitations of their Advantages
point-of-care testing instruments, whether they are Reduced therapeutic turnaround time of diagnostic testing
testing for glucose, electrolytes, blood gases, cardiac Rapid data availability
markers, coagulation indices, or other analytes. Hos- Reduced preanalytic and postanalytic testing errors
Scientific Communications
pital staff working with these instruments should be Self-contained and user-friendly instruments
Small sample volume for a large test menu
familiar with and responsible for quality manage-
Shorter patient length of stay
ment of their instruments, to ensure the reliability of Convenience for clinicians
the patient test results. Ability to test many types of samples (ie, capillary, saliva, urine)
Administrative staff (ie, nurse managers, coordi-
Disadvantages
nators of point-of-care testing programs, and man-
Concerns about inaccuracy, imprecision, and performance
agers of quality assurance programs) should keep (ie, potential interfering substances)
up-to-date with proficiency testing of operators of Bedside laboratory tests performed by poorly trained
point-of-care instruments at their facility as well as be nonlaboratorians
able to train new operators and assess operators’ Quality management/assurance issues and responsibilities
4
competence. Quality management deals with mea- not defined
Section
sures taken by operators of point-of-care instruments Cost of point-of-care testing compared with traditional
laboratory testing
to ensure that instruments are accurate and perform-
Quality of testing is operator-dependent
ing optimally. Compromising the accuracy and preci- Difficulty in integrating test results with hospital information
sion for expeditious testing is not recommended. system (HIS) or laboratory information system (LIS)—
Each medical institution should have its own quality lack of connectivity
assurance committee that is responsible for the com- Narrower measuring range for some analytes
petence of operators and for decisions about
expected performance standards of the entire testing Improvement Amendments of 1988 (CLIA ’88).
cycle. Additionally, operators must take necessary Compliance with the Joint Commission on Accredi-
measures to comply with regulations. tation of Healthcare Organizations (JCAHO, Oak-
To regulate the performance of laboratory testing brook Terrace, IL) or College of American
(including point-of-care testing), the federal govern- Pathologists (CAP, Northfield, IL) regulations is vol-
ment requires that each medical institution meet the untary. All medical institutions must comply with
standards established by the Clinical Laboratory state laws. These laboratory testing regulations help
to ensure the high-quality performance of the
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Table 4. Preanalytic and Postanalytic Errors
Preanalytic errors
Mishandling and/or mislabeling of patient specimen parathyroid hormone (PTH) testing for parathyroid surgery,
Contamination of specimen speed alone is crucial in saving operating room time and
Degradation of specimen due to delays in specimen reducing the length of hospitalization.23 Recent studies
processing/testing and/or arrival at central laboratory
Postanalytic errors
demonstrated that point-of-care testing can reduce the length
Misreporting patient test results of hospital stay24 and time in the emergency department,25 but
Recording wrong patient test results further study is needed to validate these results.
Lost data
Delayed reporting of critical results Technology of Whole-Blood Biosensors
Whole-blood analyzers currently use both electrochemical
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90
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Advanced quality management features also
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is, the internal and analyte circuits of the instru-
ment. However, EQC doesn’t validate the perfor-
Month/Year
mance of the test cartridges or of the operator. EQC
can help generate cost savings because it is conve- Quality control (QC) compliance rates. QC compliance rates are shown as a
nient, can be completed quickly, is reagentless, function of time for critical care settings and all hospital areas at the University of
requires only a reusable EQC card, and is a benefi- California, Davis, Health System from January 1998 through September 1999. The
line for all critical care units is based on 14 different critical care settings, including
cial feature that assesses the electronic measure-
intensive care units, the operating room, and the emergency department. The line
ment cycle of the instrument. It is important to for all hospital areas is based on 57 settings. The graph shows progressive
realize that manufacturers of instruments with the performance enhancement after instituting electronic mail broadcasting.
EQC feature do not recommend substituting EQC
for aqueous QC. Aqueous and electronic QC thus ensuring proper usage of the instrument. Some
should both be performed. instruments require that proper patient identification
A QC “lockout” feature, when enabled, does not be entered before testing can proceed. This action
allow the operator to perform any patient testing ensures proper documentation of test results.
unless quality control testing has been performed and
has satisfied the vendor-specified QC ranges. Other Future of Point-of-Care
lockout and security features include a password Instruments and Testing
option, which must be entered by a certified operator An important issue to address now about POCT is
before the instrument can be used for patient testing, the accuracy, performance, and reliability of these
Scientific Communications
Table 6. Methods for Analyte Measurements
Method
Ion-Selective Substrate-Specific Electrical Conductance Analyte-Specific Optical
Analyte Electrode (ISE) Electrode (SSE) Sensor (ECS) Sensor (ASOS)
Ca++ Yes No No No
Mg++ Yes No No No
K+ Yes No No No
Cl– Yes No No No
4
Na++ Yes No No No
Section
pH Yes No No Yes
PCO2 CO2-sensitive buffer, No No Yes
with pH electrode
pO2 No Amperometric No Yes
Glucose No Yes No No
Lactate No Yes No No
Urea Nitrogen No Yes No No
Creatinine No Yes No No
Hematocrit No No Yes No
Hemoglobin No No No Multiwavelength
reflectance
Total CO2 Acid displacement, No No No
CO2-sensitive buffer,
with pH electrode
O2 saturation No No No Optical reflectance
J U LY 2 0 0 0 VO L U M E 3 1 , N U M B E R 7 L A B O R ATO RY M E D I C I N E 407
instruments for patient testing in the critical care set- 5. Louie RF, Tang Z, Sutton DV, et al. Point-of-care testing:
ting. More study is needed to examine the limita- effects of critical care variables, influence of reference instru-
ments, and a modular glucose meter design. Arch Pathol Lab
tions of these instruments and to resolve any Med. 2000;124:257-266.
potential error sources (eg, interfering substances) 6. Kost GJ. Guidelines for point-of-care testing: improving
that may affect instrument performance. How- patient outcomes. Am J Clin Pathol. 1995;104(suppl 1):S111-
S127.
ever, in regard to short-term advances with point- 7. Kilgore ML, Steindel SJ, Smith JA. Evaluating stat testing
of-care technology, we will see continued options in an academic health center: turnaround time and
expansion of test menus, shorter analysis time, staff satisfaction. Clin Chem. 1998;44:1597-1603.
8. Chernow B, Salem M, Sacey J. Blood conservation: a criti-
and reduced sample volume. For example, several
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