NATtrol Respiratory Verification Panel 2.1 (qualitative) * is formulated with intact and purified bacterial cells and viral particles. The microorganisms have been chemically modified to make them non-infectious and stable in the refrigerator. NATRVP2.1-BIO contains 23 vials of 0.6 mL of bacterial and viral NATtrol and 1 x 0.6 mL of negative (matrix only) as indicated in Table 1. Panel members are supplied in a proprietary matrix.
NATtrol Respiratory Verification Panel 2.1 is designed to evaluate the performance of nucleic acid tests for the presence of bacterial and viral nucleic acids (from the organisms listed in Table 1.) NATRVP2.1-BIO allows laboratories to monitor the test drift, batch-batch test kit performance, operator drift and can assist in identifying random or systemic errors.
NATtrol Respiratory Verification Panel 2.1* (qualitative) is formulated with purified, intact bacterial cells and viral particles. The microorganisms have been chemically modified to render them noninfectious and refrigerator stable. NATRVP2.1-BIO contains 23 x 0.6 mL vials of bacterial and viral NATtrol™ and 1 x 0.6 mL of negative (matrix only) as listed in Table 1. The panel members are supplied in a proprietary matrix.
NATtrol Respiratory Verification Panel 2.1 is designed to evaluate the performance of nucleic acid tests for the determination of the presence of bacterial and viral nucleic acids (from organisms listed in Table 1.) NATRVP2.1-BIO enables laboratories to monitor test variation, lot-to-lot test kit performance, operator variation and can provide assistance in identifying the random or systemic error.
WARNINGS AND PRECAUTIONS:
- NATtrol inactivation was carried out on microorganism stocks used to formulate the panel members. The inactivation was verified in a standard microbiological growth protocol.
- This panel contains inactivated microorganisms and materials of human and animal origin. Safe practices suggest that the controls are considered potentially infectious and to use Universal Precautions when handling.
- Refer to CDC guidelines and local regulations for handling and disposal.
- The matrix used in the manufacture of this product is treated with 0.09% sodium azide. It was manufactured from Human Serum Albumin that has been tested and found to be 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 Fetal Bovine Serum used in the manufacture of this product meets 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.
- Do not use past the expiration date on the label.
- To avoid cross-contamination, use separate pipette tips for all materials.