Therapy Areas: Infectious Diseases
Siemens Healthineers Granted US FDA Emergency Use Authorization for Clinitest Rapid COVID-19 Antigen Self-Test
30 December 2021 - - The US Food and Drug Administration has granted Emergency Use Authorization for the Clinitest Rapid COVID-19 Antigen Self-Test, providing nationwide access to a new at-home or over-the-counter self-test as COVID-19 testing needs continue to grow for individuals, families, and businesses, German medical technology company Siemens Healthineers (OTC: SMMNY) said.

The nasal swab test is intended to aid in the rapid detection of SARS-CoV-2 (the virus that causes COVID-19) and provides visually read test results in just 15 minutes.

It is authorized for self-testing use by individuals age 14 and older or adult-collected samples from individuals ages 2 to 13 years.

The test is expected to be available starting in January. Siemens Healthineers has secured dedicated production capacity for US bound product in the tens of millions per month.

The product comes in a specific configuration for the United States and has been evaluated in a study specifically designed for the US market and fully conducted in the US with laypersons, thereby covering currently circulating variants of SARS-CoV-2.

Meeting the high threshold of the US FDA, the product is highly accurate, with sensitivity of 86.5% (95% CI: 79.6 to 91.3%) and a specificity of 99.3% (95% CI: 95.9 to 100.0%) compared to the nucleic acid detection method.

Sensitivity defines the test's ability to produce a positive result in those infected with SARS-CoV-2 per the PCR reference method, and specificity defines the ability to produce a negative result in those not currently infected with SARS-CoV-2.

All clinical data has been established under Siemens Healthineers participation in the National Institutes of Health Rapid Acceleration of Diagnostics' Independent Test Assessment Program.

Reliable results can help consumers make confident, informed decisions about their daily lives, with the simplicity of a nasal swab test at home. Consumers who receive a positive test result should follow guidance from the Centers for Disease Control and Prevention to isolate and take steps to mitigate the spread of COVID-19.

Siemens Healthineers has distinguished itself as a provider of quality diagnostic assays to aid the fight against the COVID-19 pandemic.

In addition to antibody, antigen, and molecular SARS-CoV-2 tests, Siemens Healthineers offers a broad diagnostics portfolio across point of care and laboratory applications to aid in the prognosis, treatment and follow-up of COVID-19 patients.

The company's broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels.

Blood gas testing and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.

In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization.

This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Federal Food, Drug, and Cosmetic Act, 21 USC. § 360bbb-3(b) (1), unless the declaration is terminated or authorization is revoked sooner.