FDA has granted emergency use authorization for the QuantiVirus PCR diagnostic from DiaCarta, Richmond, Calif. The test specifically detects three different genes of SARS-CoV-2, the virus that causes covid-19.
DiaCarta recently expanded manufacturing capacity to 500,000 tests per week and is planning to expand to even larger scale manufacturing to meet the increasing demand for PCR tests to monitor 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, which are detected by a real-time quantitative reverse transcriptase PCR assay. The assay offers high sensitivity and specificity, with a limit of detection of 100 copies/mL and no detectable crossreactivity to other human respiratory pathogens.
US reference labs and hospitals with high-complexity molecular diagnostic laboratories can now use QuantiVirus kits to detect SARS-CoV-2 within 2 hours following RNA extraction.
“We are already supporting laboratories in the US and overseas to meet their increasing testing needs,” says Ram Vairavan PhD, senior vice president at DiaCarta. “Our Dx reagent kit can be used with commonly available PCR instruments, such as the Applied Biosystems 7500 and QuantStudio 5.”
DiaCarta earlier announced that it has received a CE mark for its product. For more information, visit DiaCarta.