The US FDA has issued an emergency use authorization for the GWU SARS-CoV-2 RT-PCR Test to George Washington University’s Public Health Laboratory.

The assay is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens — such as nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabs — from individuals suspected of COVID-19 by their healthcare provider.

The test extracts, isolated and purifies the SARS-CoV-2 nucleic acid from the specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument.

Read the EUA here.