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TaqPathTM COVID-19 Combo Kit contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid (RNA) from SARS-CoV-2 in upper respiratory specimens in acute phase of infection
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Sample types bronchoalveolar lavage (BAL), mid-turbinate swabs, nasal swabs, nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and oropharyngeal swabs (see Fig 1).
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Assays target three coronavirus genes: orf-1ab, S, and N having higher specificity with lower risk for mutation.
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Each run covers 94 specimens in 3 hours allowing turnaround (from sample receipt to report) within 24-48 hours.
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Positive results are indicative of the presence of SARS-CoV-2 RNA. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
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Intended use under Food and Drug Administration’s Emergency Use Authorization limited to Clinical Laboratory certified under CLIA 88.