CORPORATE
DESCRIPTION:
Accumetrics,
based in San Diego, California, began operations in April 1996, and is focused
on the design, development, manufacturing, and marketing of innovative
proprietary, point-of-care, cardiovascular diagnostic products. Accumetrics is
committed to providing accurate, reliable, and cost-effective, medical
diagnostic systems that enhance the quality of patient care throughout the
world.
The
Company's first commercial product is the Ultegra® System,
a point-of-care, bedside analyzer with single-use, disposable cartridges.
The advantages of the Ultegra System over previous products are direct use of a
vacuum-type blood collection tube (whole blood sample) and a result in minutes.
RPFA-TRAP the first assay developed for use on the system is to assess GPIIb/IIIa platelet
inhibition in response to abciximab or eptifibatide.
RPFA-ASA the second assay developed for use on the system is to aid in the detection of
platelet dysfunction due to aspirin ingestion.
The Ultegra Rapid Platelet Function Assay-ASA (RPFA-ASA) is a
qualitative test to aid in the detection of platelet dysfunction due to aspirin
(ASA) ingestion in citrated whole blood for the point of care or laboratory
setting.
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Products
| Instrument
Name
|
Ultegra
Analyzer
|
|
| Model
Name
|
Rapid
Platelet Function Analyzer (RPFA)
|
| CLIA
Classification
|
Moderate
|
| Size
and Weight
|
The Ultegra Analyzer weighs only 4 lbs (1813 grams).
The analyzer is 9 ½"(24cm) wide x 9 ¼"(23cm) long x
4"(10.4cm) high.
|
| Specifications
|
-
Voltage
Rating: 100-240~
-
Supply
Freq.: 50/60 Hz
-
Power
Rating:
35W
-
Calibration:
Factory
(electronic, mechanical, thermal, pressure)
-
Display:
Dot Matrix liquid
crystal
-
Operating
Temperature:
18-32°C (64-90°F)
-
Operating
Pressure (Altitude):
-1,000 ft to 10,000 ft
(-305m to 3,049m)
-
Operating
Humidity:
0-85% relative (noncondensing)
-
Shipping/Storage
Temperature:
-10-45°C (14-113°F)
-
Shipping/Storage
Pressure (Altitude):
-1,000 ft to 15,000 ft
(-305m to 4,573m)
-
Shipping/Storage
Humidity:
0-95% relative (noncondensing)
-
Printer
Link:
Supports Accumetrics
specified compatible printer
|
| Data
Transfer
|
All
Data produced by the analyzer are stored in the analyzer (PAU
values / ARU values, EQC testing results, patient results,
Operator ID’s, etc.)
|
| Features
|
IIb/IIIa
Inhibitors & Acetylsalicylic Acid
|
| CPT
Code
|
85576
|
| Test
Methodology
|
The Ultegra System is a turbidimetric based optical
detection system which measures platelet induced aggregation as an
increase in light transmittance.
Fibrinogen-coated microparticles are used to measure this
reaction. Fibrinogen-coated microparticles agglutinate in whole
blood in proportion to the number of unblocked platelet GP IIb/IIIa
receptors. The maximum extent of microbead agglutination is
attained more rapidly if platelets are activated; therefore a
platelet agonist is incorporated into the assay to induce platelet
activation without fibrin formation. Light transmittance increases
as activated platelets bind and agglutinate fibrinogen-coated
beads. The analyzer is designed to measure this change in optical
signal due to agglutination.
|
| Units
|
PAU
(Platelet Aggregation Units) & ARU (Aspirin Reaction Units)
|
| MSDS
References
|
|
|
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Last updated: 01/08/2003
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