Jul 06, 2021 Devices

Respiratory NATtrol

NATtrol Respiratory Pathogen Panel-1 (NATRPP-1)* is formulated with purified, intact virus particles and bacterial cells that have been chemically modified to render them non-infectious and refrigerator stable.

NAPP-1 contains a total of 6 x 0.25 mL vials: 5 vials of the viral/bacterial NATtrol targets (1 vial of each pool) and 1 vial of the Negative as listed in Table 1. These controls are supplied in a purified protein matrix that mimics the composition of a true clinical specimen.

NATtrol RPP-1 Panel is designed to evaluate the performance of nucleic acid tests for the determination of the presence of viral and bacterial nucleic acids. NAPP-1 can also be used for the verification of clinical assays, the development of diagnostic tests, and the training of laboratory personnel.

NATRPP-1 contains intact organisms and should be run in a manner identical to that used for clinical specimens.

NATtrol inactivation was carried out on the viral and bacterial stocks used to formulate panel members. The inactivation was verified by the absence of viral and bacterial 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 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.

Although NATRPP-1 contains inactivated organisms, it

should be handled as if potentially infectious.

Use Universal Precautions when handling this product.

To avoid cross-contamination, use separate pipette tips for all reagents.

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