OVERVIEW OF SYSTEM COMPONENTS - 2
VerifyNow System User Manual Page 18 14340.J
Assay devices are calibrated at the factory. No additional calibration is required by
the user. Information about calibration and the device expiration date is contained in
the bar code on the pouch of each assay device. The bar code must be scanned
whenever a new lot of assay devices is to be used.
NOTE: Handle assay devices as biohazardous material. Dispose of them in an
appropriate manner.
2.3 Sample Collection Tubes
The VerifyNow System uses whole blood collected in a partial-fill vacuum tube.
During the test, the tube is inserted onto the needle in the sample well of the assay
device - requiring no cap removal, specimen preparation, or pipetting step. There are
several types of sample collection tubes recommended for use with the system
(Table 2-1).
Table 2-1 Sample Collection Tubes
Collection Tube Description Assay
Greiner Bio-One Vacuette tube
(Greiner #454321)
Partial fill, 2 mL,
3.2% sodium
citrate. Blue top
Aspirin, P2Y12,
IIb/IIIa (only for use with ReoPro –
abciximab
)
Greiner Bio-One Vacuette tube
(Greiner #454082)
Partial fill, 3 mL
lithium heparin.
Green top
IIb/IIIa - for use with Integrilin
(
eptifibatide
) or ReoPro (
abciximab
)
Greiner Bio-One Vacuette tube
(Greiner #454237)
Partial fill, 2 mL
lithium heparin.
Green top
IIb/IIIa - for use with Integrilin
(
eptifibatide
) or ReoPro (
abciximab
)
NOTE: The use of sample collection tubes other than those listed may adversely
affect assay results.
2.4 Quality Control
Accumetrics rigorously tests each VerifyNow System to ensure it meets performance
standards. In addition, the system supports several types of quality controls to verify
continued performance during use.
2.4.1 EQC Device and Storage Slot
The Electronic Quality Control (EQC) is the primary quality control mechanism for the
VerifyNow instrument. It consists of a re-usable device that is inserted by the
operator into the assay port and is used to perform a comprehensive testing routine
that confirms instrument performance.
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