ITC VerifyNow System Platelet Reactivity Test User Manual
Page 98
Appendix - 11
Page 94
14439.C 03/2013
VerifyNow System User Manual |
USA
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Each instrument is tested with a previously qualified lot of VerifyNow test devices.
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Testing includes multiple replicates of previously qualified lots of WQC control materials.
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Each lot of VerifyNow Test devices is tested against a previously qualified lot of test devices. Testing
includes multiple replicates of WQC and blood from several normal donors.
In summary, the VerifyNow System includes a comprehensive set of quality control features, which have
been designed and incorporated into the system. The VerifyNow quality control features control all
aspects of the analytical process, as defined in the CLIA Regulation:
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Test system – instrument and reagent system
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Operator
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Environmental factors
Running the VerifyNow System according to Accumetrics’ recommended procedures meets all the CLIA
quality control requirements.