NATtrol™ SARS-CoV-2 Positive Control (6 x 0.5 mL)

NATtrol SARS-Related Coronavirus 2 Positive Control is formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable*. Each control pack contains 6 x 0.5 mL vials of NATtrol inactivated virus listed in Table 1 formulated in a proprietary purified protein matrix.

NATtrol SARS-Related Coronavirus 2 Positive Control 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 SARS-Related Coronavirus 2 Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. This qualitative control is not automated and 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.

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• ENGLISH (SDS)

NATtrol SARS-Related Coronavirus 2 Positive Control is a USA FDA Class 1 exempt, unassayed in vitro diagnostic external run control and are for professional use only. NATtrol SARS-Related Coronavirus 2 Positive Control is not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. NATtrol SARS-Related Coronavirus 2 Positive Control is not intended for use as a primary reference standard or material for any assay or testing procedure. Quality control materials should be used in accordance with local, state, federal and accreditation requirements.