NATtrol™ Influenza A/B Positive Control (IVD)MDZ046
INTENDED USE: NATtrol™ Influenza A/B Positive Control (MDZ046) is an in vitro diagnostic external run control, intended for use in evaluating and monitoring of qualitative molecular diagnostic assays for the detection of Influenza A/B nucleic acid. The routine and repetitive use of this external run control enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error. The NATtrol™ Influenza A/B Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens.
PRODUCT SUMMARY AND EXPLANATION: NATtrol™ Influenza A/B Positive Control is formulated with purified, intact organisms that have been chemically modified to render them noninfectious and refrigerator stable*. Each NATtrol™ Influenza A/B Positive Control contains 6 x 0.5 mL vials of NATtrolTM Influenza A and NATtrolTM Influenza B formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.