Chembio’s new test system includes a test cartridge, DPP Micro Reader optical analyser and a minimally-invasive nasal swab
Chembio seeks FDA EUA for rapid Covid-19 antigen test. (Credit: Michal Jarmoluk from Pixabay.)
Chembio Diagnostics has filed an application with the US Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) of its DPP SARS-CoV-2 Antigen test system.
The point-of-care diagnostics company said that its new DPP antigen test has been designed to detect SARS-CoV-2 antigens within 20 minutes.
The DPP SARS-CoV-2 Antigen test system comprises a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical analyser and a minimally-invasive nasal swab.
Chembio president and chief executive officer Richard Eberly said: “The antigen test system EUA submission is another example of the scientific expertise of our team and the flexibility of our DPP technology. We are committed to leveraging this technology to offer a comprehensive COVID-19 testing portfolio.
“The DPP platform is ideally suited as a cost-effective system for rapid testing at the point of care and can help expand patient access to testing. Rapid antigen testing has proven to be one of the most effective methods for population screening and diagnosis available today.”
Chembio develops DPP technology platform to offer results in 15 to 20 minutes
According to the US Centres for Disease Control and Prevention (CDC), antigen tests are immunoassays that detect the presence of a specific viral antigen, implying a current viral infection.
Chembio has developed its own DPP technology platform, which offers high-quality, rapid diagnostic results within 15 to 20 minutes using a small drop of blood from the fingertip or other samples.
The DPP platform is capable of detecting up to eight different test results from a single patient sample, delivering superior clinical value compared other rapid tests, said the company.
The DPP Micro Reader optical analyser is a battery-operated, portable, and easy-to-use, component in the test system that precisely reports results in around 15 seconds.
Chembio said that the objective results from the DPP Micro Reader are said to reduce different types of human errors that can be occurred due to visual interpretations in many of rapid tests.
The company has a portfolio of DPP-based point-of-care tests, including PMA approved DPP HIV-Syphilis System, PMA approved and CLIA waived DPP HIV 1/2 Assay, FDA 510(k) approved DPP Zika IgM System, and FDA EUA granted DPP Ebola Antigen System.
Also, DPP-based tests have received regulatory approvals from the World Health Organisation (WHO), CE-Mark, Agência Nacional de Vigilância Sanitária (ANVISA), and other global organisations.
Chembio noted that all of its DPP tests are being developed and manufactured in the US.
Eberly added: “Offering both antibody and antigen testing using the same Micro Reader will enable clinicians to both diagnose and monitor Covid-19 infection status with Chembio products.
“Thank you to our team and to BARDA for their support throughout the development of the antigen system. We look forward to working with the FDA to achieve EUAs as soon as possible for the DPP SARS-CoV-2 Antigen test system and our previously submitted antibody test system.”