Diagnostic features a test card that reveals a color band to reflect negative or positive results. EpiGentek: Three-Minute COVID-19 Blood Test on the Way EpiGentek, a N.Y.-based biotechnology firm specializing in epigenetic assay products and services, is launching a rapid serological test to detect the COVID-19 virus. The method uses blood samples such as fingertip blood and can deliver results in under 15 minutes and as fast as three minutes. The company, known for its fast and easy antibody-based assays, recently sent to the U.S. Food and Drug Administration (FDA) a notice of intent to distribute the kits and expects full availability in mid-April. The test, SeroFlash(TM) SARS-CoV-2 IgG/IgM Antibody Detection Kit, comprises of a test card that will reveal a color band to reflect negative or positive results. Based on colloidal gold immune technology, the test identifies the presence of SARS-CoV-2 antibodies. Blood samples are mixed with diluent and added to the test card with results indicated within three to 15 minutes. A clinical study with various serum, plasma, and whole blood samples from 267 patients has demonstrated a 93.7 percent testing accuracy, with increased accuracy of 98.9 percent if counting whole blood samples alone. The method has also been validated for 100 percent negative correlation to other human coronaviruses and influenza. William Lee, vice president of operations at EpiGentek, said, "Given our resources and expertise, we feel it is our duty to join the fight for public safety in the wake of the crisis. I am proud that we can offer a rapid solution to healthcare professionals and organizations who are struggling to keep stock of testing kits for incoming patients." Lee explained that the goal is make the test widely accessible by lowering handling difficulty and cost. At around $10 to $20 per test, SeroFlash does not require any special analytical devices or instruments. Whereas current testing results are often delayed by several days due to the need for special sample preparation and equipment, SeroFlash's rapid turnaround time and simplicity is ideal for use at the point of care by healthcare personnel and practitioners. This test also has broader implications, which enables scientists to identify and confirm immunity through detection of SARS-CoV-2 antibodies. Such identification allows for the immune to return to work and anchor the economy as well as help care for the vulnerable. The company is also working on the release of a second testing kit based on rRT-PCR, which uses specific primer and probe sets to detect RNA from SARS-CoV-2 in patients with symptoms of COVID-19. EpiGentek plans to file for EUA (emergency use authorization) with the FDA. Source
