Accumetrics VerifyNow User Manual page 126

to discard an assay device where a color change is evident. The Assay
Device Humidity Indicator detects errors due to adverse environmental
conditions.
• Assay Device Kit Temperature Indicator: Each VerifyNow Assay kit has a
temperature indicator on the outside of the packaging. The user is instructed
to inspect the indicator upon receipt of the kit. If the indicator has changed
color, the kit has been exposed to elevated temperatures, and a Wet Quality
Control (WQC) Level 2 must be run to ensure that the reagents are
performing properly. The Temperature Indicator detects errors due to
adverse environmental conditions.
11.9.1.3 VerifyNow Assay Wet Quality Controls (WQC)
• Wet Quality Controls Levels 1 and 2 are available from Accumetrics for
verifying the integrity of the VerifyNow System and for evaluating operator
proficiency. WQC Level 1 and Level 2 are formulated at clinically relevant
levels. In the VerifyNow Assays, Level 1 is representative of a sample with
platelet inhibition, and Level 2 is representative of a sample with no platelet
inhibition.
Laboratories may elect to run these controls on a regular basis for QC of the
VerifyNow Assays, although Accumetrics believes that the comprehensive QC
components built into every VerifyNow assay make this unnecessary.
Accumetrics recommends that Level 2 WQC be run under the following
conditions:
•
Whenever a new shipment or lot number of VerifyNow Assay Devices is
received.
•
When a temperature indicator changes color, indicating that a VerifyNow
Assay kit has been exposed to elevated temperatures.
•
In the case of repeated failures of the Assay Device Internal Control, to
rule out degradation of assay device reagents as the cause of the failure.
• VerifyNow Assay WQC may be used as a tool for other types of activities
required by the CLIA Regulation, other than the daily quality control
requirements. These activities include the following:
•
Proficiency testing
•
Laboratory personnel competency evaluation
•
Establishment and verification of system performance specifications
(493.1253)
•
Analytical system quality assessment (493.1289)
Accumetrics Customer Support can advise on the use of WQC as tools in
meeting these CLIA requirements.
NOTE: The recommendation for the VerifyNow IIb/IIIa Assay only is to run Level 2
WQC with each lot or shipment, or every 30 days.
VerifyNow System User Manual Page 126
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