Accumetrics VerifyNow User Manual page 127

11.9.1.4 Accumetrics Quality Control Procedures
To assure that VerifyNow System components are of the highest quality, Accumetrics
subjects its products to rigorous quality control procedures before they are shipped to
customers.
• Each VerifyNow Instrument is tested mechanically, optically and electrically
throughout the manufacturing process. The instrument's performance is
validated by comparing it to Accumetrics' internal reference standards. The
validation process consists of the following:
•
Test results are correlated to results from a qualified reference VerifyNow
Instrument
•
Each instrument is extensively tested with previously qualified lots of
VerifyNow assay devices.
•
Testing includes multiple replicates of previously qualified lots of WQC
control materials.
• Each lot of VerifyNow Assay devices is tested against a previously qualified
lot of assay 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:
• Test system – instrument and reagent system
• Operator
• Environmental factors
Running the VerifyNow System according to Accumetrics' recommended procedures
meets all the CLIA quality control requirements.
VerifyNow System User Manual Page 127
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