Product Description:
NaTtrol (NATMECBIO) * Meningitis / Encephalitis (ME) Controls are formulated with intact and purified viral particles and fungal cells that have been chemically modified to produce they are non-infectious and stable in the refrigerator. Each control package contains 6 vials of 0.2 ml of ME Control 1 and 6 vials of 0.2 ml of ME Control 2. NATtrolTM ME controls are supplied in a protein matrix that mimics the composition of a true clinic sample.
Expected Use:
- NATtrol ™ ME controls are designed to evaluate the conducting nucleic acid tests for the determination of the presence of viral, bacterial and fungal nucleic acids. NATMEC-BIO can also be used to evaluate batch by batch
lab training and test kit performance personal. - NATMEC-BIO contains intact organisms and must run in an identical manner to that used for the clinic specimens.
Etiological / Biohazard Status Tests:
- NATtrol ™ inactivation was carried out on the stocks used to formulate each control. The inactivation was verified by the absence of growth invalidated tissue culture-based infectivity assays and growth protocols.
- The purified protein matrix used in the manufacture of this product is treated with 0.09% sodium azide. It was made from materials that have been tested and found non-reactive at the donor level for HIV-1 / HIV-2 Antibody, HBsAg and HCV Antibody licensed by the FDA donor screening test methods. All materials are also tested for HIV-1 and HCV by Nucleic FDA approved Acid Test Methods (NAT). Heat inactivated cattle source materials based on the manufacture of this product meets applicable USDA requirements for animals of origin from the slaughterhouse, traceability and country of source.
- The materials were collected at USDA licensed establishments or legally imported from countries recognized by the USDA as insignificant or controlled by the risk of bovine spongiform encephalopathy (BSE) and other exotic pathogens. Donor animals were inspected ante and post mortem at the slaughterhouse as
required by USDA.
Precautions:
- Although NATMEC-BIO contains inactivated organisms, it should be handled as if it were potentially infectious.
- Use universal precautions when handling this product.
- To avoid cross-contamination, use separate pipette tips for all reagents.
Recommended Storage:
- NATtrol ™ ME controls should be stored at 2-8 ° C