DiaCarta’s QuantiVirus PCR Diagnostic Test Receives US FDA Emergency Use Authorization

(Richmond, CA, USA), a precision molecular diagnostic company, has secured Emergency Use Authorization from the US FDA for its proprietary QuantiVirus™ PCR diagnostic (Dx) test specifically detecting three different genes of SARS-CoV-2. DiaCarta has also received Conformitè Europëenne (CE) Mark for the product. The company recently expanded its manufacturing capacity to 500,000 tests per week and plans to expand to even larger (4x) scale manufacturing in order to meet the increasing demand for PCR tests for monitoring COVID-19.

The QuantiVirus™ test detects all currently known strains of SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and sputum samples. The three viral RNA-encoded genes are the N, Orf1ab and E genes detected by real-time quantitative Reverse Transcriptase PCR assay enabling high sensitivity and specificity with a limit of detection of 100 copies/mL without any detectable cross-reactivity to other human respiratory pathogens. Users, including US reference labs and hospitals with high-complexity molecular Dx laboratories, can now use QuantiVirus™ kits to detect SARS-CoV-2 within two hours following RNA extraction.

“We are already supporting laboratories in the US and overseas to meet their increasing testing needs as our Dx reagent kit can be used with commonly available PCR instruments, such as Applied Biosystems 7500 and QuantStudio 5,” said Ram Vairavan PhD, DiaCarta Senior Vice President. “We have validated this Dx test in our CLIA lab and are serving current needs of global organizations offering SARS-CoV-2 testing to front line providers.”

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