PCR Testing Information

Polymerase Chain Reaction (PCR)

Performed on specimens obtained via nasopharyngeal, nasal, and/or oropharyngeal synthetic swabs. SARS-CoV-2/COVID-19 Viral Identification by PCR. This high-complexity molecular test methodology incorporates a multi-step process that isolates, buffers, extracts, amplifies, and labels viral genetic material. The substrate is subjected to an automated, instrument-embedded, 40-cycle analysis with sensitivity and specificity validations >85-95% representing the methodology most widely accepted by CDC, FDA, NIH, ASCP, CLIA as confirmatory for the presence of SARS-CoV-2 (the virus which causes COVID-19).

PCR Instrumentation authorized for COVID-19 testing under FDA Emergency Use Authorization:

1. Thermo Fisher Molecular PCR System with King Fisher Extractor; Quant Studio 12K Flex
Real-Time PCR System and Applied Biosystems 7500 Fast Dx Real-Time PCR
Instrument

2. Quidel SARS-CoV-2/COVID-19 Lyra Molecular Assay by PCR

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Please note the tests are not for private use. Tests should be performed by trained healthcare personnel.