SARS-CoV-2 Plus Quantitative Flu A/ Flu B RT-PCR

The SARS-CoV-2 Plus Quantitative Flu A and B RT-PCR test is intended for the qualitative detection of SARS-CoV-2, and the quantitative detection of Influenza A, Influenza B.

About SARS-CoV-2 and Influenza A and B

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.

Human Influenza A viruses are medically important pathogens that cause significant morbidity and mortality throughout the world. The emergence of the 2009 H1N1 influenza A virus has led to increased vigilance in monitoring these infections. Unlike Influenza A viruses, Influenza B virus is found only in humans. Influenza B virus is a negative-sense, single-stranded RNA. Type B flu may cause a less severe reaction than type A flu virus, but type B can still be extremely harmful for the immunocompromised.

Extraction of SARS-CoV-2*, Influenza A and B 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 was developed and its performance characteristics determined by Viracor Eurofins. It 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.

*The Coronavirus SARS-CoV-2 RT-PCR 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.

Coronavirus SARS-CoV-2 RT-PCR

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.

Influenza A and B qRT-PCR

The primers and probes used in the INFA assay are specific for known H3N2, pandemic (2009) H1N1 and seasonal H1N1 and the primers and probes used in the INFB assay are specific for known INFB strains.  Additionally, no cross reactivity was detected when tested against ADV, CMV, EBV, HSV-1, HSV-2, Enterovirus, Parainfluenza virus, Coronavirus 229E, SARS CoV-2, Rhinovirus, RSVA, RSVB,  C. pneumoniae and Group A Strep.  In silico analysis has demonstrated that Viracor’s INFA or INFB assays are not expected to cross-react with other respiratory viruses, bacteria or fungal pathogens/commensals.