QUALITY CONTROLS - 5
VerifyNow System User Manual Page 29 14340.J
8.
If the instrument is operating within its specifications, PASS will display at the
conclusion of the testing (Figure 5-6). In addition, numeric values will be reported
for the diagnostics, along with the acceptable range for each parameter. When
the EQC is complete, press the Next key to return to the main menu.
Figure 5-6 EQC Result
If there is a problem detected during the EQC process and the instrument is not
operating within its specifications, a FAIL message will display. The failed
parameter(s) will be indicated by an arrow (←) to the right of the measured
value(s). Press the Next key and perform the corrective action described.
When the corrective action is completed, repeat the EQC. If diagnostic failure
displays a second time, record the name of the parameter(s) indicated by an
arrow (←) (e.g. V1, V2, O1) and contact Customer Support. Refer to Chapter 10,
Troubleshooting for more information.
NOTE: Results can be printed using the printer accessory. Press the key to
print results if this accessory is included with your system.
5.2 Wet Quality Control
The VerifyNow instrument also supports two levels of wet quality controls. Wet
Quality Control (WQC) is intended to be used with a diluent and an assay device as a
basis for quantitative quality control. Specifically, the WQC measures two levels of
turbidimetric signal that verify the dynamic range of the instrument. One of these
signals is at the level that would be observed in a patient with a minimal amount of
platelet aggregation (negative control), and the other represents a patient who
demonstrates a significant amount of aggregation (positive control).
NOTE: VerifyNow Assay WQC also may be used as a tool for activities other than
routine quality control requirements. These activities include: proficiency testing,
laboratory personnel competency evaluation, establishment and verification of
system performance specifications and analytical system quality assessment.
5.2.1 Level 1 WQC
WQC Level 1 is formulated at a clinically relevant level and is representative of a
sample with platelet inhibition. During Level 1 WQC, diluent is used to verify
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