NATtrol Flu Verification Panel

NATtrol™ Flu Verification Panel

Flu Verification Panel (7 X 0.5 mL)

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Catalog Number: NATFVP-NNS

PRODUCT DESCRIPTION:

NATtrol™ Flu Verification Panel (NATFVP-NNS)* is formulated with purified, intact virus particles that have been chemically modified to render them non-infectious and refrigerator stable. NATFVP-NNS panel contains 7 x 0.5 mL vials each containing viral NATtrol™ targets listed in Table 1. These controls are supplied in a purified protein matrix that mimics the composition of a true clinical specimen.

*Pat.:http://www.zeptometrix.com/patent-information/

INTENDED USE:

• NATtrol™ Flu Verification Panel is designed to evaluate the performance of nucleic acid tests for determination of the presence of viral nucleic acids. NATFVP-NNS can also be used for verification of clinical assays, development of diagnostic tests and training of laboratory personnel.
• NATFVP-NNS contains intact organisms and should be run in a manner identical to that used for clinical specimens.

ETIOLOGIC STATUS/BIOHAZARD TESTING:

• NATtrol™ inactivation was carried out on each member in the panel. The inactivation was verified by the absence of viral growth in validated tissue culture based infectivity assays.
• 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.

PRECAUTIONS:

• Although NATFVP-NNS 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.

RECOMMENDED STORAGE:

• NATtrol™ Flu Verification Panel should be stored at 2- 8°C.

INSTRUCTIONS FOR USE:

• Extract panel member prior to use in downstream assays.

DO NOT USE IN HUMANS. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES.

These products are intended for research, product development, quality assurance or manufacturing use. These products are NOT intended for use in the manufacture or processing of injectable products subject to licensure under section 351 of the Public Health Service Act or for any other product intended for administration to humans.

**Please note that although similar in nomenclature, this is a 2009 H1N1 pandemic Influenza strain and does NOT correlate with the seasonal 2009 Influenza strains found in the Fludb.org database. For reference, the NCBI Taxon IDs for the seasonal Influenza strains listed in the Fludb.org database are: A/New York/01/2009 (H1N1) - 666252; B/New York/01/2009 - 664512; A/New York/02/2009 (H1N1) - 666298; and A/New York/03/2009 (H3N2) - 659637.