EZ™-SARS-CoV-2 Real-Time RT-PCR is a real-time RT-PCR test intended for the qualitative detection of RNA from the SARS-CoV-2 in nasopharyngeal, oropharyngeal, and nasal swab 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, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. The EZ™-SARS-CoV-2 Real-Time RT-PCR is distributed in accordance with the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.
The Tetracore, Inc. EZ™-SARS-CoV-2 Real-Time RT-PCR is a molecular in vitro test that aids in the detection and diagnosis of SARS-CoV-2 and is based on widely used nucleic acid amplification technology. The product contains oligonucleotide primers and dual-labeled hydrolysis probes (TaqMan®) and control material used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens.
The oligonucleotide primers and probes for detection of SARS-CoV-2 were selected from regions of the virus nucleocapsid protein (N) gene. The test is designed for specific detection of SARS-CoV-2 viral RNA. An additional primer/probe set to detect the endogenous human RNase P gene in clinical specimens is also included in the test, and a separate primer/probe set is included to detect an Inhibition Control (IC) added either to the initial extraction process or to the mastermix.