A real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) test run on the Revogene® instrument for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab (NPS) specimens collected from individuals suspected of having a COVID-19 infection.
Catalog Number: 410700
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- This test has not been FDA cleared or approved.
- Validation of this test has not been reviewed by FDA. Review under the EUA program is pending.
- Results of the Revogene SARS-CoV-2 test should be used in conjunction with other clinical and laboratory findings, including patient history to determine patient infection status. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.