The new fluorecare antibody test kit has been designed to determine the presence of COVID-19 or a potential indication of antibody immunity to COVID-19
NovaBay collaborates with Shenzhen Microprofit Biotech to distribute rapid COVID-19 test in the US. (Credit: AhmadArdity/Pixabay)
US-based biopharmaceutical firm NovaBay has partnered with Shenzhen Microprofit Biotech to exclusively distribute a rapid COVID-19 test in the US.
The new fluorecare SARS-CoV-2 IgG & IgM antibody combined test kit is a point-of-care colloidal gold chromatographic immunoassay test, designed to determine the presence of COVID-19 or a potential indication of antibody immunity to COVID-19.
The test works by analyzing a drop of blood, collected by healthcare professionals, and detects the presence of COVID-19 antibodies through results available in approximately 10 minutes.
NovaBay CEO Justin Hall said: “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.
“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.”
NovaBay intends to file US FDA Emergency Authorization Use (EAU) for its fluorecare test kit
NovaBay said that the fluorecare test kit has been validated through the RT-PCR testing to detect immunoglobulin M (IgM) and immunoglobulin G (IgG). The test kit has been granted ISO 13485 and CE Mark approval.
IgM is the first antibody produced in response to initial exposure to the COVID-19 antigen, and IgG provides a potential indication of antibody-based immunity to COVID-19.
The company intends to submit the fluorecare test kit to the US Food and Drug Administration (FDA) under Emergency Authorization Use (EAU), which allows emergency use of in vitro diagnostic tests for detection and diagnosis of COVID-19.
Also, NovaBay will submit an FDA permanent FDA 510(k) application for the approval of the fluorecare antibody test kit.
Hall added: “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.”