The FastPack COVID-19 antibody test is a chemiluminescent microparticle test intended for the qualitative detection (i.e., yes/no) of SARS-CoV-2 IgG antibodies in blood to identify individuals with an adaptive immune response to the virus that causes COVID-19, indicating recent or prior infection of the disease
Qualigen Therapeutics announced it has begun commercial shipments of its FastPack SARS-CoV-2 IgG diagnostic test for Covid-19 antibodies.
This test has been submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), and earlier this month the Company submitted an official notification to the FDA of its plans to exercise its right to commence sales while the EUA is pending.
The FastPack COVID-19 antibody test is a chemiluminescent microparticle test intended for the qualitative detection (i.e., yes/no) of SARS-CoV-2 IgG antibodies in blood to identify individuals with an adaptive immune response to the virus that causes COVID-19, indicating recent or prior infection of the disease. Prior infection is presumed to be indicative of immunity against re-infection for at least some period of time.
The COVID-19 antibody test is designed for use with Qualigen’s new FastPack PRO System, a point-of-care diagnostic instrument. The FastPack PRO System is an upgraded version of Qualigen’s flagship FastPack IP rapid immunoassay diagnostic system – in essence, a “lab in a box” that allows test results to be delivered with the accuracy of large laboratories but much more rapidly.
Unlike tests at reference laboratories, the FastPack tests are conducted in physician offices, clinics and hospitals, and provide results in approximately 10 minutes. The Company announced earlier this month that a portion of the proceeds from its recent funding will be used to increase production of the FastPack PRO System.
“We are pleased to start shipping our FastPack PRO systems and serology tests for COVID-19 antibodies, and expect to see a ramp-up of production through the end of the year,” stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen.
“Testing for SARS-CoV-2 IgG antibodies is likely to be critical to fighting this disease for years to come, not only in this early stage of tracking and tracing, but also in time to prioritize vaccine deployment. We believe our rapid diagnostics offering provides accurate results for clinicians to have more timely and actionable information than other testing approaches can provide.”
Qualigen has been producing high-quality diagnostic testing products for nearly 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people’s lives.
Source: Company Press Release