Biotechnology firm EpiGentek is launching a rapid serological test that it said can detect the virus that causes COVID-19 in less than 15 minutes.
Using plasma, serum, or whole blood samples such as fingertip blood, the colloidal gold immune technology-based test can detect immunoglobulin G/immunoglobulin M (IgG/IgM) antibodies to SARS-CoV-2 in as little as three minutes, according to the firm. Blood samples are mixed with diluent and a test card then reveals a color band that reflects negative or positive findings. In a clinical study of 267 patients, the kit had an overall testing accuracy of 93.7%, including an accuracy of 98.9% in whole blood samples.
EpiGentek said it has sent a notice of intent to the U.S. Food and Drug Administration (FDA) that it intends to distribute the test, called the SeroFlash SARS-CoV-2 IgG/IgM antibody detection kit. The product is expected to become widely available by mid-April at a cost of $10 to $20 per test.
In addition, EpiGentek said it's working on a second testing kit based on reverse transcription polymerase chain reaction (RT-PCR) technology, using specific primer and probe sets to detect RNA from SARS-CoV-2 in patients with symptoms of COVID-19. The firm plans to file for an emergency use authorization (EUA) with the FDA for this test.
