NATtrol™ RSV Positive Control (IVD)MDZ047
INTENDED USE: NATtrol™ RSV Positive Control (MDZ047) is an in vitro diagnostic external run control, intended for use in evaluating and monitoring of qualitative molecular diagnostic assays for the detection of Respiratory Syncytial Virus (RSV) 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™ RSV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens.
PRODUCT SUMMARY AND EXPLANATION: NATtrol™ RSV Positive Control is formulated with purified, intact organisms that have been chemically modified to render them noninfectious and refrigerator stable*. Each NATtrol™ RSV Positive Control contains 6 x 0.5 mL vials of NATtrolTM RSV formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.