The rapid finger prick test will enable to detect the presence of COVID-19 or potentially indicate antibody immunity to COVID-19
NovaBay Pharmaceuticals has entered into an agreement with Shenzhen Microprofit Biotech to exclusively distribute a COVID-19 antibody rapid point-of-care test in the US.
The rapid finger prick test will help identify the presence of COVID-19 or potentially indicate antibody immunity to COVID-19.
The fluorecare SARS-CoV-2 IgG & IgM antibody combined (colloidal gold chromatographic immunoassay) test kit will enable healthcare professionals to use a drop of blood to detect COVID-19 antibodies and provide results within 10 minutes.
According to the company, the fluorecare test kit has been validated via widely used RT-PCR testing to identify immunoglobulin M (IgM) and immunoglobulin G (IgG).
The IgM is said to be the first antibody produced in response to initial exposure to the COVID-19 antigen, while the IgG is believed to offer a potential indication of antibody-based immunity to COVID-19.
The fluorecare test kit has also been CE mark certified
The fluorecare test kit also secured CE mark approval to use in the European Union (EU) region.
NovaBay intends to seek the emergency authorisation use (EAU) for the test from the Food and Drug Administration (FDA).
The firm also plans to submit the fluorecare test kit for permanent FDA 510(k) clearance.
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.
In October 2019, NovaBay entered into an exclusive 90-day agreement with NuSight Medical for the supply of dry-eye treatment NuLids System in certain US geographies.