NovaBay to Distribute COVID-19 Antibody Rapid, Finger Prick Point-of-Care Test

By LabMedica International staff writers
Posted on 23 Apr 2020

Image: fluorecare® SARS-CoV-2 IgG & IgM Antibody Combined Test Kit (Photo courtesy of NovaBay Pharmaceuticals, Inc)

NovaBay Pharmaceuticals, Inc. (Emeryville, CA, USA) has entered into an agreement with Shenzhen Microprofit Biotech Co., Ltd. (Guangdong, China) to become the exclusive US distributor of a rapid, finger prick test to determine the presence of COVID-19 or a potential indication of antibody immunity to COVID-19. NovaBay will submit the fluorecare test kit to the US Food and Drug Administration (FDA) under Emergency Authorization Use (EAU) and will also submit it for permanent FDA 510(k) clearance so that the test kit can continue to be used once the state of emergency has been declared over by the federal government.

The fluorecare SARS-CoV-2 IgG & IgM Antibody Combined (colloidal gold chromatographic immunoassay) Test Kit is a point-of-care test to be administered by healthcare professionals. The test uses a drop of blood for the detection of COVID-19 antibodies with results available in approximately 10 minutes. The fluorecare test kit has been validated through widely used RT-PCR testing to detect immunoglobulin M (IgM), which is the first antibody produced in response to initial exposure to the COVID-19 antigen, and immunoglobulin G (IgG), which provides a potential indication of antibody-based immunity to COVID-19. The fluorecare test kit has been ISO 13485 and CE Mark certified

“Public health experts and leaders across our country are citing a critical need for mass testing and tracing procedures for those who are infected or have been infected with COVID-19 before reopening the nation’s economy,” said Justin Hall, NovaBay CEO. “Nasopharyngeal (back of the nose and throat) swabs for molecular detection are expensive and require laboratory testing that can lead to delays in obtaining results. Through a simple finger prick, IgG/IgM testing could provide for cost-effective detection of COVID-19 antibodies with results available in minutes as an important step in tracking the infection.

“We are delighted once again to work with our global health supplier network to secure a product that can help our communities during the COVID-19 pandemic and, subject to FDA clearance, we plan to offer the fluorecare test kit at very competitive pricing,” he added.

Related Links:
NovaBay Pharmaceuticals, Inc.
Shenzhen Microprofit Biotech Co., Ltd.