The SARS-CoV-2 Test Kit (Real-time PCR) is an in vitro diagnostic real-time reverse transcription-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs, anterior/mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA which is generally detected in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Laboratories within the United States and its territories are required to report all positive results to the
appropriate public health authorities.
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.
Testing with the SARS-CoV-2 Test Kit (Real-time PCR) is intended for use by qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The SARS-CoV-2 Test Kit (Real-time PCR) is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The SARS-CoV-2 Test Kit (Real-time PCR) is a multiplex, Taqman probe-based one-step reverse transcription polymerase chain reaction (RT-PCR), which enables simultaneous qualitative detection of ORF1ab and a region of the N gene that are specific for SARS-CoV-2 as well as a non-human internal control (Armored RNA for SUC2) in one reaction. For ease of storage and transportation, the amplification reagent is designed as a pre-distributed dry reagent (lyophilized).
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