NATtrol SARS-Related Coronavirus 2 (SARS-COV-2) Negative Control-IVD

The NATtrol SARS-Related Coronavirus 2 Negative 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 Negative Control contains 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.

Each NATtrol SARS-Related Coronavirus 2 Negative Control contains 6 x 0.5 mL vials of A-549 cells formulated in a proprietary purified protein matrix.

CE marked ; Cepheid GeneXpert, Luminex Aries, BioFire Assays, QIAGEN QIAstat-Dx, GenMark ePlex, Abbott ID Now ; Test : SARS, Coronavirus / +2° to +8° C. / IVDD-CE-UKCA

Product Insert.pdf

Material Safety Data Sheet.pdf