ITC VerifyNow System Platelet Reactivity Test - Manual (Page 24)

Quality Controls - 5
Page 20 14439.C 03/2013 VerifyNow System User Manual | USA
7. 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
EQC
Result:
PASS
26-Feb-2012
14:57:00
01(0.1-1.5): 0.30
02(0.8-3.6): 1.20
V1(5.25: 5.45
V2(0.30): 0.23
P1(-.25-0.5): 0.48
F1(14-16): 14
F2(11-16): 14
Mask: 0000
EQC
Result:
FAIL
26-Feb-2012
14:57:00
01(0.1-1.5): 0.30
02(0.8-3.6): 1.20
V1(5.25: 6.10
V2(0.30): 0.23
P1(-.25-0.5): 0.48
F1(14-16): 14
F2(11-16): 13
Mask: 000E<-
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 Technical 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 a test 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 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 continued performance by checking that
actual results are within a standard range. It takes approximately 3 to 5 minutes to complete using the
following procedure:
NOTE: Pressing the Back key will stop the quality control test at any point and return to the main menu.
Materials
You will need 1 test device and 1 WQC diluent tube.
NOTE: Do not use test devices or WQC materials beyond the expiration date.