Coronavirus (COVID 19) RT-PCR Test

The lab test for Coronavirus SARS-CoV-2 RT-PCR is intended for the qualitative detection of SARS-CoV-2.

About Coronavirus SARS-CoV-2 RT-PCR and COVID-19

Please refer to the CDC website for the most up to date information on SARS-CoV-2 or COVID-19 at
https://www.cdc.gov/coronavirus/2019-ncov/summary.html.

At the end of 2019, an outbreak of the virus initially referred to as 2019 novel Coronavirus, later identified as SARS-CoV-2, occurred in Wuhan, Hubei Province, China. A betacoronavirus, like MERS-CoV and SARS-CoV, the virus originates from bats. As of January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared a “public health emergency of international concern.”

The disease caused by SARS-CoV-2 has been named coronavirus disease 2019, abbreviated as COVID-19. Main symptoms of the disease include fever, cough and shortness of breath. The CDC recommends reaching out to a physician if you develop symptoms and have been in close contact with a person known to have COVID-19; or if you have recently traveled from an area with widespread or ongoing community spread of COVID-19. The virus is spread via person-to-person contact through respiratory droplets produced when a person coughs or sneezes. The best preventative measures are to avoid close contact with people who are sick; avoid touching nose, eyes and mouth; cover a cough or sneeze with a tissue and discard immediately; and clean and disinfect frequently touched objects and surfaces using a household cleaning spray or wipe. Washing your hands with soap and water for at least 20 seconds frequently is one of the best preventative measures and hand sanitizer can be used when soap and water are not available.

Extraction of SARS-CoV-2 virus nucleic acid from specimen, followed by combined reverse transcription of viral RNA and PCR amplification using real-time reverse transcriptase PCR (RT-PCR) methods. An internal control is added to ensure that extraction was performed correctly and that the RT-PCR reaction was not inhibited.

This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of SARS-CoV-2 virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

COVID-19 EUA LDT for Healthcare Providers

COVID-19 EUA LDT for Patients

Abbott RealTime SARS-CoV-2
The Abbott RealTime SARS-CoV-2 assay is real-time reverse transcription polymerase chain reaction (RT-PCR) test on the Abbott m2000 System. The SARS-CoV-2 primer and probe sets are designed to detect RNA from SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from patients with signs and symptoms of infection who are suspected of COVID-19. 

The Abbott RealTime SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Abbott RealTime SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Abbott Fact Sheet for Healthcare Providers

Diatherix Eurofins' SARS-CoV-2 TEM-PCR^TM 
Target Enriched Multiplex PCR^TM diagnostic panel testing consists of three major steps: extraction, amplification and detection. The key to making TEM-PCR^TM occur successfully lies in these primer mixes and how they allow the enrichment of multiple targets. The use of target-specific nested primers at low concentrations at the initial enrichment step allows high specificity of multiplexing amplification. After initial target enrichment is complete, Super Primers within the reaction carry out the exponential amplification and produce tagged PCR products for subsequent detection. The detection phase of the process is accomplished by measuring the fluorescence of special tags that are bound to the target sequences, which have been attached during amplification. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Testing performed utilizing TEM-PCR (Target Enriched Multiplex Polymerase Chain Reaction) technology. Testing laboratory is Diatherix Eurofins, 601 Genome Way, Suite 2100 / Huntsville, AL 35806 CLIA ID: 01D1085737.

The Diatherix TEM-PCR test has been validated but FDA's independent review of the validation is pending. These tests are performed as a laboratory developed test; independent review of the validation under the FDA's Emergency Use Authorization (EUA) authority will be performed according to current guidance requirements. This test was developed and the performance characteristics determined by Diatherix Eurofins. This test has not been cleared or approved by the U.S. Food and Drug Administration. Results should be used in conjunction with clinical findings, and should not form the sole basis for a diagnosis or treatment decision. 

In silico analysis has demonstrated that Viracor’s SARS-CoV-2 RT-PCR is not expected to cross-react with other coronaviruses (including other SARS viruses and other common respiratory coronaviruses). Additionally, this assay will not cross-react with other respiratory viruses, bacteria or fungal pathogens/commensals.