Research & Development
DiaCarta Inc files FDA EUA for highly sensitive QuantiVirus SARS-CoV-2 Test
25 March 2020 -

Molecular diagnostic company DiaCarta Inc revealed on Tuesday that it has filed for Emergency Use Authorization (EUA) with the US FDA for its QuantiVirus SARS-CoV-2 test.

The company has validated the COVID-19 diagnostic test in its own CLIA certified lab in Richmond, CA to provide testing services for healthcare providers and patients. It has recently received the Conformitè Europëenne (CE) Mark for its QuantiVirus SARS-CoV-2 test.

Based on Real-Time PCR technology, the company's in vitro diagnostic test is developed for specific detection of SARS-CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum from patients suspected with coronavirus infection. Three genes of SARS-CoV-2 including N, Orf1ab and E genes are targeted in the real-time PCR (qRT-PCR) assay to ensure high degree of sensitivity and accuracy.

According to the company, the analytical sensitivity is 1-5 copy/uL of SARS-CoV-2 viral RNA for patient sample with a 95% confidence. Clinical validation of the assay showed 96.7% sensitivity and a specificity of 100%, with no cross-reaction to different types of non-SARS-CoV-2 species.