NATtrol Neisseria gonorrhoeae (NG) Positive Controls (MDZ003) consist of in vitro diagnostic external run controls intended for use with qualitative molecular assays. 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 error.
NATtrol inactivation was completed on the stocks used to formulate each control and further verified by the absence of bacterial growth in a validated growth protocol.
The Purified Protein Matrix used in the manufacture of this product is treated with 0.09% sodium azide. It was manufactured from materials that have been tested and found non-reactive at the donor level for HIV-1/HIV-2 Antibody, HBsAg and HCV Antibody by FDA licensed donor screening test methods. All materials are also tested for HIV-1 and HCV by FDA-approved Nucleic Acid Test (NAT) methods.
Heat-inactivated bovine-based source materials used in the manufacture of this product meet applicable USDA requirements for abattoir sourced animals, traceability, and country of origin. The materials were collected at USDA licensed establishments or legally imported from countries recognized by the USDA as negligible or controlled for risk for Bovine Spongiform Encephalopathy (BSE) and other exotic disease agents. Donor animals were inspected ante and post mortem at the abattoir as required by the USDA.
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