INTENDED USE
The COVID-19 RT-PCR test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to the Center for Esoteric Testing, Burlington, NC, or other laboratories designated by LabCorp that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable 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 COVID-19 RT-PCR test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Testing with the COVID-19 RT-PCR test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR is only for use under the Food and Drug Administration’s Emergency Use Authorization.

LabCorp COVID-19 RT-PCR test EUA Summary
DEVICE DESCRIPTION AND TEST PRINCIPLE
The COVID-19 RT-PCR Test is a real-time reverse transcription polymerase chain reaction (rRT -PCR) test. The test uses three primer and probe sets to detect three regions in the SARS-CoV-2 nucleocapsid (N) gene and one primer and probe set to detect human RNase P (RP) in a clinical sample. RNA isolated from upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) is reverse transcribed to cDNA and subsequently amplified using Applied Biosystems QuantStudio7 Flex (QS7) instrument with software version 1.3. During the amplification process, the probe anneals to a specific target sequence located between the forward and reverse primers. During the extension phase of the PCR cycle, the 5’ nuclease activity of Taq polymerase degrades the bound probe, causing the reporter dye (FAM) to separate from the quencher dye (BHQ1), generating a fluorescent signal. Fluorescence intensity is monitored at each PCR cycle by QS7.


INSTRUMENTS USED WITH TEST
The COVID-19 RT-PCR test is to be used with the Roche MagNA Pure-96 (MP96) using MagNA Pure 96 DNA and Viral NA Small Volume Kit and Applied Biosystems QuantStudio7 Flex (QS7) instrument with software version 1.3.