NATtrol EV Panel

NATtrol EV Panel - 20 X 0.2 mL

PRODUCT DESCRIPTION:

NATtrol™ Enterovirus (EV) Panel (NATEVP-C)* is formulated with purified, intact virus particles that have been chemically modified to render them non-infectious and refrigerator stable. NATEVP-C panel contains 20 x 0.2 mL vials each containing viral NATtrol™ targets listed in Table 1. Each panel contains 3 tubes of each of the Enterovirus Positive members and 5 tubes of the Enterovirus Negative member (Parechovirus 1). The panel members are supplied in a purified protein matrix that mimics the composition of a true clinical specimen.

INTENDED USE:

• NATtrol™ EV Panel is designed to evaluate the performance of nucleic acid tests for determination of the presence of Enterovirus nucleic acids. NATEVP-C can also be used for verification of clinical assays, development of diagnostic tests and training of laboratory personnel.
• NATEVP-C contains intact viral particles and should be run in a manner similar to that used for clinical specimens.

ETIOLOGIC STATUS/BIOHAZARD TESTING:

• NATtrol™ inactivation was carried out on each virus stock used to formulate 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. 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.

PRECAUTIONS:

• Although NATEVP-C contains inactivated virus particles, 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™ EV Panel should be stored at 2-8°C. INSTRUCTIONS FOR USE:
• Shake NATtrol™ sample vigorously for 5 seconds.
• Follow the assay manufacturer’s instructions for use to process the sample as a clinical sample.

EXPECTED RESULTS:

• Qualitative results are shown in Table 1 below.
• Each laboratory must evaluate the controls and establish their own acceptance criteria.
• The table shown below is for informational purposes only.