NATtrol RSV Positive Control (6 X 0.5 mL)

ZeptoMetrix external controls have demonstrated performance on a variety of molecular assays. The product has been tested with the Cepheid® GeneXpert® system and provides the expected results, however performance characteristics must be established by the end user. Formulated with purified, intact organisms Organisms are chemically modified to render them noninfectious Refrigerator stable—store between 2 and 8°C Purified protein matrix treated with 0.09% sodium azide 6 x 0.25 mL vials of RP Control 1 and 6 x 0.25 mL vials of RP Control 2 CE IVD NATtrol™ RSV Positive Control (NATRSV-6C-IVD) 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. NATtrol™ RSV Positive Control is a US FDA Class 1 device, 501(K) exempt, in vitro diagnostic external run control (unassayed) intended for professional use only. This product is not intended for use as a substitute for internal controls provided by in vitro diagnostic kit manufacturers. Quality control materials should be used in accordance with local, state, federal, and accreditation requirements. Propagation or commercialization are prohibited without prior written consent from Antylia Scientific. When used as a control for nucleic acid tests, the same protocols as those used to amplify extracted clinical specimens should be employed. The suitability and performance characteristics should be determined by your laboratory for each intended usage.