The test is intended for the qualitative detection of IgG and IgM protein from the SARS-CoV-2 virus in capillary ‘fingerstick’ whole blood, plasma, and serum samples
Beroni submits FDA EUA for COVID-19 Rapid Test Detection Kit. (Credit: Pixabay/Ahmad Ardity)
Australia-based biopharmaceutical firm Beroni has submitted an Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for its IgG/IgM antibody SARS-CoV-2 rapid test detection kit.
The company said that it has developed a new SARS-CoV-2 IgG/IgM antibody detection kit based on colloidal gold, which is a rapid single-use immunochromatographic test.
The test is intended for the qualitative detection of IgG and IgM protein from the SARS-CoV-2 virus in capillary ‘fingerstick’ whole blood, plasma, and serum samples.
Beroni offers pharmaceutical products in Australia, US, China and Japan
The company has requested the US FDA for EUA, which is currently under review, and is expected to begin the manufacturing and shipment of test kits to customers, once the FDA agrees to issue the EUA.
Beroni is an international biopharmaceutical firm focused on commercialisation of drugs and therapies to combat various global diseases such as cancer and infectious diseases.
The company has a diversified portfolio of FDA approved virus diagnostic kit, an e-commerce platform for the sale of pharmaceutical products and a pipeline of oncology and cell therapies, operating in Australia, US, China and Japan.
In response to the coronavirus pandemic, US-based health care firm UnitedHealth announced that a recent study showed that a simple, patient-administered test is effective in identifying COVID-19 infections.
The study consisted of nearly 500 patients at OptumCare facilities in Washington state.
The less invasive test is said to reduce exposure for health care workers and improve overall testing efficiency across the country.
Besides, US-based Astrotech said that it is developing BreathTest-1000, to screen for volatile organic compound (VOC) metabolites in breath that could indicate lung infections, including COVID-19 or pneumonia.