Accumetrics VerifyNow User Manual page 125

Control), and the other represents a patient who demonstrates a
significant amount of aggregation (Positive or High Level Control).
•
The required EQC testing frequency is input into the VerifyNow Instrument
by the user. Accumetrics recommends that the EQC be run at least on a
daily basis, although the institution may select their preferred EQC testing
frequency. When the established interval has elapsed, the user is locked
out from running a patient test until the EQC test has been successfully
completed.
•
When run according to Accumetrics' recommendations, the EQC
meets CLIA requirements for daily QC of the instrument system.
• System Controls for Each Sample Tested: Each time an assay device is run
on the VerifyNow System, the instrument verifies the device expiration date,
sample filling, optics performance, correct fluid transfer, and proper mixing.
The system controls prevent the operator from running an expired assay
device. The system also detects certain other operator errors, such as
placing the assay device or the sample in the instrument at the wrong time, or
removing the assay device before the assay is complete. These controls
prevent reporting of an inaccurate test result. These controls exceed the
CLIA requirement for daily QC because they are performed for each assay
device.
11.9.1.2 VerifyNow Assay Device
• Assay Device Internal Controls: Each assay device incorporates two levels of
quality control to identify invalid test runs caused by random errors, reagent
degradation or inappropriate blood samples. Before platelet activation and
fibrinogen binding begin, the Negative (Aspirin) or Low-Level (P2Y12 and
IIb/IIIa) Internal Control performs a test for non-specific aggregation. During
the active phase of the assay, the Positive (Aspirin) or High-Level Internal
Control channel monitors the reaction and calculates Clinical Control Units,
which must fall within specified limits. A failure of either internal control
results in an error message by the VerifyNow Instrument, which prevents the
reporting of an inaccurate result.
The assay device internal controls can detect failures of the reagent system
due to improper storage or handling conditions. The internal controls will also
flag an improperly collected or mishandled blood sample, or a blood sample
with certain types of interfering substances. The Assay Device Internal
Controls detect errors from the reagent system, adverse environmental
conditions, and additional types of operator errors. The Assay Device
Internal Controls exceed the CLIA requirement of daily controls because
two levels of control are run with each assay.
• Assay Device Humidity Indicator: Each assay device contains an internal
humidity sensor. If the assay device has been degraded due to exposure to
excessive humidity, a color change of the humidity indicator will be observed.
The user is instructed to check the color of the indicator before each test, and
VerifyNow System User Manual Page 125
APPENDIX - 11
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