FDA Authorizes Siemens Healthineers COVID-19 Antigen Self-Test

FDA recently granted emergency use authorization for Siemens Healthineers’ CLINITEST Rapid COVID-19 Antigen Self-Test.

The nasal swab test is a point-of-care cassette test that does not require laboratory tools or specialized lab personnel to administer. Results are available to patients in 15 minutes.

The agency authorized the test for individuals 14 years of age and older or adult-collected samples from children aged two to 13. The test will be available in January 2022.

“Undetected COVID-19 exposure is a major driver of community spread. With the CLINITEST Rapid COVID-19 Antigen Self-Test, consumers will have access to a fast, reliable, and convenient test to provide additional safety,” Christoph Pedain, PhD, head of point of care diagnostics at Siemens Healthineers, said in the announcement.

“Siemens Healthineers is proud to bring this high-quality test, already used and trusted by families, medical professionals, businesses and governments in many parts of the world, to the United States under FDA Emergency Use Authorization.”

In a study specifically designed for the US market, the CLINITEST Rapid COVID-19 Antigen Self-Test demonstrated sensitivity of 86.5 percent and a specificity of 99.3 percent compared to the PCR detection method.

And in February 2021, Siemens Healthineers received the CE mark to use anterior nose swab sampling for the CLINTEST Rapid COVID-19 Antigen Self-Test.

At the time, a US study enrolled 237 subjects, 109 of which were confirmed COVID-19 positive with a PCR test. The study showed a 97.3 percent sensitivity and 100 percent specificity versus another FDA emergency use authorized rt-PCR assay.

Siemens Healthineers has been active in the fight against COVID-19 since the beginning of the pandemic, launching antibody, antigen, and molecular SARS-CoV-2 tests.

Last November, Siemens Healthineers launched its  SARS-CoV-2 IgG Antibody Test (COV2G), which previously proved to measure neutralizing antibodies. 

The COV2G test became the fifth antibody test from Siemens Healthineers to receive authorization that showed greater than 99 percent specificity.

Currently, Siemens Healthineers’ antibody tests are available on one of the largest installed bases of automated immunoassay analyzers globally and in countries that accept the CE mark worldwide.