NATtrol Enterovirus (EV) External Running Controls (NATEVPOS-6MC, NATEVNEG-6MC) are formulated with intact and purified viral particles that have been chemically modified to render them non-infectious and stable in the refrigerator. Each control contains 6 x 0.2 ml vials of NATtrol Coxsackievirus or NATtrol Parechovirus. These controls are supplied in a purified protein matrix that mimics the composition of a real clinical sample.
- NATtrol EV External Execution Controls are comprehensive process controls designed to evaluate the performance of nucleic acid tests for the presence of EV nucleic acids. NATEVPOS-6MC and NATEVNEG-6MC can also be used for quality control of clinical trials and training of laboratory personnel.
- NATEVPOS-6MC and NATEVNEG-6MC contain intact viral particles and should be analyzed in a manner similar to that used for clinical specimens.
ETIOLOGICAL / BIOHAZARD STATUS TESTS:
• NATtrol ™ inactivation was performed on the virus stocks used to formulate each control pack. Inactivation was verified by the absence of viral growth in infectivity assays based on validated tissue cultures.
• The purified protein matrix used in the manufacture of this product is treated with 0.09% sodium azide. Manufactured from materials that have been tested and found to be non-reactive at the donor level for HIV-1 / HIV-2 antibody, HBsAg, and HCV antibody by donor screening methods licensed by the FDA.
All materials are also tested for HIV-1 and HCV using FDA-approved Nucleic Acid Test (NAT) methods. The heat-inactivated materials of bovine origin used in the manufacture of this product meet the applicable USDA requirements for slaughterhouse animals, traceability, and country of origin.
The materials were collected from USDA licensed facilities or legally imported from countries recognized by the USDA as insignificant or controlled for the risk of bovine spongiform encephalopathy (BSE) and other exotic diseases. Donor animals were inspected ante and post mortem at the slaughterhouse as required by the USDA.
- Although NATtrol Influenza / RSV External Run Controls contain inactivated organisms, they should be handled as potentially infectious.
- Use universal precautions when handling these products.
- To avoid cross-contamination, use different pipette tips for all reagents.
NATtrol EV External Function Controls should be stored at 2-8 ° C.
INSTRUCTIONS FOR USE:
Shake the NATtrol sample vigorously for 5 seconds.
Follow the assay manufacturer’s instructions for use to process the specimen as a clinical specimen.
- Qualitative results are shown in Table 1 below.
- Each laboratory must evaluate the controls and establish its own acceptance criteria.
- The table below is for informational purposes only.