In a press release, the manufacturer, Siemens Healthineers, announced that the FDA granted EUA for the CLINITEST Rapid COVID-19 Antigen Self-Test, which will provide nationwide access to the new at-home or OTC self-test for COVID-19 for individuals, families, and businesses. The CLINITEST is an easy-to-use nasal swab test that is intended to aid in the swift detection of SARS-CoV-2 (the virus that causes COVID-19) and provides visually read test results in just 15 minutes.

The new at-home test is authorized for self-testing use by individuals aged 14 years and older or adult-collected samples from individuals aged 2 to 13 years. The test is expected to be available in January 2022. Siemens Healthineers has secured dedicated production capacity for United States-bound product in the tens of millions per month.

In the press release, Christoph Pedain, PhD, head of Point of Care Diagnostics, Siemens Healthineers, stated, "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. 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."

The self-test comes in a specific configuration for the U.S., has been assessed in a study specifically designed for the U.S. market, and fully conducted in the U.S. with laypersons, thus covering currently circulating variants of SARS-CoV-2.

The company indicates that meeting the high threshold of the FDA, the product is highly accurate, with sensitivity of 86.5% (95% CI: 79.6%-91.3%) and a specificity of 99.3% (95% CI: 95.9%-100.0%) compared with the nucleic acid (PCR) 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.

Dr. Pedain also stated, "The CLINITEST Rapid COVID-19 Antigen Self-Test detects SARS-CoV-2 antigens in people who are actively infected with the virus, making important information more readily available. We'd like to thank the U.S. Government, specifically the National Institutes of Health Rapid Acceleration of Diagnostics' Independent Test Assessment Program, for their partnership in bringing much needed tests to the American people. We know this is a critical time in this pandemic, and we will do our part in providing support."

The manufacturer noted that reliable results can assist consumers in making confident, informed decisions about their daily lives with the ease of nasal swab test at home, and consumers who received a positive test result should follow guidance from the CDC to isolate and take recommended measures to lessen the transmission of the COVID-19 virus.

More information about the CLINITEST Rapid COVID-19 Antigen Self-Test is available at

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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