1. The TaqPath™ RT-PCR COVID-19 Kit workflow should be performed by qualified and trained staff to avoid the risk of erroneous results. Use separate areas for the preparation of patient samples and controls to prevent false positive results. Samples and reagents must be handled in a biological safety cabinet.
2. The assay is for in vitro diagnostic use under the FDA Emergency Use Authorization Only.
3. This test has not been FDA cleared or approved.
4. This test has been authorized only for the detection of nucleic acid fromSARS-CoV-2, not for any other viruses or pathogens.
5. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21
U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
6. Samples and controls should always be treated as if infectious and/or biohazardous in accordance with safe laboratory procedures.
7. Follow necessary precautions when handling specimens. Use personal protective equipment (PPE) consistent with current guidelines for the handling of potentially infectious samples.
8. Always use pipette tips with aerosol barriers. Tips that are used must be sterile and free from DNases and RNases.
9. Do not eat, drink, smoke, or apply cosmetic products in the work areas.
10. Reagents must be stored and handled as specified. See manufacture instructions.
11. Components of reagent kits of different lot numbers must not be interchanged.
12. Do not use the kit after the indicated expiry date.
13. Dispose of waste in compliance with local, state, and federal regulations.
Positive results are indicative of the presence of SARS-CoV-2 RNA