NATtrol Influenza/RSV Negative Control (6 X 0.5 mL)

ZeptoMetrix external controls have demonstrated performance on a variety of molecular assays. The product has been tested with 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 0.5 mL vials CE IVD The NATtrol™ Influenza/RSV Negative Control Verification Panel is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls 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 errors. NATtrol™ Influenza/RSV Negative Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol Influenza/RSV Negative 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. NATtrol™ Influenza/RSV Negative Control tested negative for Influenza A, Influenza B, and RSV in the Xpert® Xpress Flu/RSV Assay. Product homogeneity has been demonstrated by validation studies and quality control testing. Each laboratory must evaluate the controls and establish its own acceptance criteria.