Architect

Abott Architect I 1000 SR fully automated random access

immunoassay analyzer
Primary components of an ARCHITECT System
Each ARCHITECT System, regardless of type, consists of three primary
components:
• System control center- provides a common user interface
across all ARCHITECT System configurations.
• Processing modules, - performs all sample processing activities
from aspiration to final read. The type(s) and number(s) of processing
module(s) determines your system configuration.
• Sample handlers, - transports samples through an ARCHITECT
System. Each system has a single, primary sample handler regardless of
the number of processing modules and types.
ARCHITECT i1000SR System
The ARCHITECT i1000SR System is a fully-automated immunoassay system
allowing random and continuous access as well as priority and automated retest
processing
Legend:
1. i1000SR processing module: Diagnostic module with priority processing
capability that performs sample processing using the CMIA (chemiluminescent
microparticle immunoassay) method.
2. RSH - robotic sample handler (c4000/i1000SR/ci4100): Transport
module that presents samples to the processing module(s) for analysis and
retesting.
3. System control center: Computer system that provides user control of
the processing module(s) and related components through a centralized interface.

The SCC (system control center) is a computer system that provides the
software interface to the ARCHITECT System and can provide an interface to a
host computer. From the SCC you can:
• Configure the system
• Enter patient, control, and calibration orders
• Review patient results, control data, and calibration results
• Control the processing module(s) and the sample handler
• Perform system diagnostics and maintenance procedures
• Receive test orders and diagnostic data from a host computer
• Transfer test results to a host computer
Loading samples (RSH)
Calibrators, controls, and patient samples are loaded on the RSH (robotic
sample handler) for routine, priority, or batch processing.
ARCHITECT i System principles of operation provides an overview of the CMIA
(chemiluminescent microparticle immunoassay) technology, assay processing,
and optical system used for analyte measurement.

CMIA method
CMIA (chemiluminescent microparticle immunoassay) is a detection method
used by an i System to measure and quantify analyte concentration.
CMIA technology and reaction sequence
CMIA (chemiluminescent microparticle immunoassay) is a technology used to
determine the presence of antigens, antibodies, and analytes in samples.
The reactants necessary for CMIA technology include:
• Paramagnetic microparticles coated with a capture molecule (antigen,
antibody, or viral particle) specific for the analyte being measured
• Acridinium-labeled conjugate
• Pre-Trigger Solution and Trigger Solution
Operation
A CMIA reaction sequence is the order of interactions between the analyte
present in the sample and the reactants. A sequence is specific to the assay
protocol.
The following two-step reaction sequence illustrates the basic principles of a
reaction.
1. The pipettor dispenses microparticles (paramagnetic microparticles coated
with capture molecules) into the sample in the reaction vessel. The vortexer
mixes the reaction mixture.
2. The reaction mixture incubates and the analyte present in the sample binds
to the corresponding capture molecules on the microparticles forming the
immune complex.
3. A magnet attracts the paramagnetic microparticles (bound to the specific
analyte) to a wall of the reaction vessel. The wash zone manifold washes
the reaction mixture to remove unbound materials. Further processing can
now take place.
4. The pipettor dispenses a chemiluminescent acridinium-labeled conjugate.
The conjugate binds to the immune complex to complete the reaction
mixture.
5. The reaction mixture incubates.
6. The wash zone manifold washes the reaction mixture to remove unbound
materials.
7. The pre-trigger nozzle dispenses Pre-Trigger Solution (hydrogen peroxide)
and the CMIA optical system takes a background read. Pre-trigger performs
the following functions:
– Creates an acidic environment to prevent early release of energy (light
emission).
– Helps to keep microparticles from clumping.
– Splits acridinium dye off the conjugate bound to the microparticle
complex. This action prepares the acridinium dye for the next step.
8. The trigger nozzle dispenses Trigger Solution (sodium hydroxide) to the
reaction mixture. The acridinium undergoes an oxidative reaction when
exposed to peroxide and an alkaline solution. This reaction causes the
chemiluminescent reaction to occur. N-methylacridone forms and releases
energy (light emission) as it returns to its ground state.
9. The CMIA optical system measures the chemiluminescent emission
(activated read) over a predefined time period to quantitate the analyte
concentration or to determine qualitative interpretations for index (cutoff)
assays.
Optical measurements (i System)
Optical measurement is the process an i System uses to obtain RLU (relative
light unit) readings, and then convert them to assay-specific analyte
concentration units or qualitative interpretations for index (cutoff) assays.
Luminometer (sample cell, injection system, PMT)
Optical system and measurement sequence (i System)
The optical system on the processing module is a system that directs the
chemiluminescent emission from the reaction vessel to the CMIA
(chemiluminescent microparticle immunoassay) reader

Legend:
1. Photomultiplier tube (PMT)
2. CMIA reader
3. Light pipe
4. Trigger Solution delivery nozzle
5. Reaction vessel
6. Magnet
7. CMIA shutter assembly
Measurement occurs as the optical system performs the following:
1. Closes the shutter around the reaction vessel to seal off ambient light
2. Turns on the high voltage to the PMT (photomultiplier tube), takes a
background read (Pre-Trigger Solution has already been dispensed), and
transfers the data to the CPU (central processing unit)
3. Dispenses Trigger Solution into the reaction vessel
NOTE: This solution initiates the chemiluminescent reaction that results in
the emission of photons of light.
4. Uses the light pipe to collect the emitted light and directs it to the PMT,
which is in the CMIA (chemiluminescent microparticle immunoassay) reader
5. Takes the activated read by collecting the emitted photons of light
6. Transfers the count data to the CPU
NOTE: The chemiluminescent light produced during this reaction is directly
or indirectly proportional to the amount of analyte present in the sample,
depending on the type of assay.
7. Sums the signal over a defined time period to yield the RLU (relative light
unit)
8. Turns off the high voltage PMT
9. Opens the shutter
Data reduction calculation (i System)
Data reduction calculation is the method used to calculate the final read in RLUs
(relative light units). The calculation is:
Final Read (RLU) = Activated Read - Background
In performing the data reduction calculation the system:
1. Sums the signal measured by the CMIA optical system
2. Verifies that:
– Background counts fall within an acceptable range
– Activated read profile falls within an acceptable set of ranges
3. Subtracts the background counts from the activated read counts to
calculate the final read and converted it to concentration units
Assay processing (i1000SR)
Many kinds of assay processing activities take place between sample aspiration
and the final read. The movement of the process path, the timing of these
movements, and the position of the components allow each reaction activity to
occur at a specified time and location.
The following illustration shows the components surrounding the process path
that are used for assay measurement
 Figure
3.36: System assay processing components (i1000SR)
Legend:
1. RV Loader assembly (RVL)
2. Upper waste manifold (UWM)
3. Wash zone manifold (WM)
4. Wash zone outlet diverter (WZOD)
5. Pipettor wash (PW)
6. RV access door (RVA)
7. Vortexer 2 (VTX2)
8. Pipettor (P)
9. Pre-trigger/trigger manifold (PT/T)
10. CMIA reader (CMIA)
11. Vortexer 1 (VTX1)
12. Process path (PP)
13. Unload diverter (ULD)
14. Unloader (UL)
15. Process path motor (PPM)
16. Wash zone inlet diverter (WZID)
17. Pipettor syringe (PS)
i System technology, known as Chemiflex technology, provides you with a variety
of protocols or assay processing methods. Depending on the type of protocol,
assay processing steps occur at different positions on the process path.
The Intelli-flow feature of the i1000SR System provides a robust wash process
for the pipettor probe by using an enhanced wash cup design and wash
algorithm. This wash process is accomplished by increasing the wash flow rate
when required to minimize interferences. In addition the software provides a
smart-scheduler to minimize assay to assay interferences when specific
combinations of assays are tested.
Sample volume requirements
Sample volume requirement depend on the sample vessel type, the onboard
sample storage conditions, and the assay(s) ordered.
Sample cup volumes
The ARCHITECT System calculates the minimum sample cup volume required to
test a sample as follows:
i System:
50 µL (sample cup dead volume) + combined sample volume of the ordered
assays and replicates
a minimum volume of 150 µL is required.
To ensure accurate liquid level detection, do not fill the sample cups above the
1400 µL mark.
Primary tube volumes
When using primary tubes, remove any tube closures and verify at least 8 mm of
sample is available above the clot, gel separator, or plasma/red cell interface to
avoid contamination of the sample during aspiration.
Aliquot tube volumes
When using aliquot tubes, remove any tube closures and verify adequate sample
is present in the tube.
Use the sample gauge label to verify at least 8 mm of sample is present in the
tube. Verify adequate sample volume above the separation point in a primary tube
by using the sample gauge label
a. Hold the primary tube so that the separation point is level with the
bottom of the sample gauge label.
b. Verify the amount of sample above the separation point is at least
equivalent to the sample gauge label. This volume is adequate for one
test.
The ARCHITECT System requires a minimum of 150 µL for routine testing of
controls and patient samples. This recommendation supports onboard sample
storage for three hours under average laboratory conditions without observable
concentration effects due to sample evaporation.
i1000SR processing module maintenance categories
Maintenance procedures for an i1000SR processing module are grouped by
category (tab) on the Maintenance screen. Procedures are available in the
following categories:
• Daily maintenance description (i1000SR processing module)
• Weekly maintenance description (i1000SR processing module)
• Monthly maintenance description (i1000SR processing module)
• As-needed maintenance description (i1000SR processing module)
Daily maintenance description (i1000SR processing module)
Daily maintenance for an ARCHITECT i1000SR is required on the processing
module only. Perform Daily maintenance procedure daily
Daily Maintenance
Perform this daily maintenance procedure to:
• Clean the outside of the probes in the wash zone
• Mix the microparticle bottles on the reagent carousel
• Dry the vacuum pump filter
• Flush and prime the wash zone, pre-trigger, and trigger manifolds
• Verify that a backup has been performed in the last thirty (30) days. If it has
not, the operator is instructed to perform one.
• Check the database integrity
NOTE: The backup verification and database integrity check are only performed
on the i1000SR processing module when it is module 1.
Materials Required module
Estimated time
needed status
• WZ probe
maintenance
water
10 minutes bottle Warming or Ready
• Tap water or
saline
• Reagent carrier
Weekly maintenance description (i1000SR processing module)
Weekly maintenance for an ARCHITECT i1000SR is required on the processing
module only. Perform these procedures weekly:
• Probe Cleaning - Manual, page 9-87
• Pipettor/WZ Probe Cleaning, page 9-88
• Wash Cup Cleaning, page 9-88
Probe Cleaning - Manual
Perform this weekly maintenance procedure to clean the outside of the pipettor
and wash zone probes to remove salt buildup.
 Materials Required module
Estimated time
needed status
• Wash bottle with
5 minutes deionized water Warming or Ready
• Cotton swabs
Pipettor/WZ Probe Cleaning
Perform this weekly maintenance procedure to clean and condition the pipettor
probe and to clean the WZ (wash zone) probes.
Materials Required module
Estimated time
needed status
• Maintenance
Cleaning Bottle
(LN
02G16-99)
• 0.5% sodium
15 minutes hypochlorite Warming or Ready
solution
• Probe
Conditioning
Solution (LN
01L56)

Wash Cup Cleaning

Perform this weekly maintenance procedure to clean the wash cup and wash
cup baffle to remove salt buildup.
Materials Required module
Estimated time
needed status
• Cotton swabs Stopped, Warming,
2 minutes
• Deionized water or Ready
Monthly maintenance description (i1000SR processing module)
Monthly maintenance for an i1000SR is required on the processing module only.
Perform this procedure monthly:
• Air Filter Cleaning
Air Filter Cleaning
Perform this monthly maintenance procedure to manually remove dust buildup
from the air filters. Since the filters must be reinstalled dry, it is recommended
you rotate between two filters to improve efficiency.
Materials Required module
Estimated time
needed status
• Air filters Stopped, Warming,
10 minutes
• Tap water or Ready

As-needed maintenance description (i1000SR processing module)

Perform the recommended as-needed maintenance procedures on an i1000SR
processing module during troubleshooting/diagnostics or during a routine
operation when problems are observed. Perform these procedures as needed:
• Pipettor Calibration
• Air Flush
• Flush Fluids
• Prime Wash Zone
• Prime Pre-Trigger and Trigger
• Internal Decontamination
• Temperature Check
• Temperature Status
• Buffer Run