USA – Siemens Healthineers has announced that the CLINITEST Rapid COVID-19 Antigen Self-Test1,2 for self-testing for the SARS-CoV-2 virus is now available in the United States.

The CLINITEST Rapid COVID-19 Antigen Self-Test, which comes in a five-test-per-box configuration, uses a simple nasal swab to provide accurate COVID-19 test results (including for both the Omicron and Delta variants) in 15 minutes.

The test is approved for unsupervised self-testing by people aged 14 and up, as well as adult-collected samples from people aged 2 to 13, with or without symptoms.

On January 24, the company was chosen as a test supplier to support the federal government of the United States’ efforts to ship tests directly to households.

Siemens Healthineers is bringing millions of rapid COVID-19 antigen tests to the United States to make them available to the American people at a time when the tests are desperately needed,” said Jennifer Zinn, Executive Vice President and Head of Diagnostics, North America, Siemens Healthineers.

Over the next two months, Siemens Healthineers has committed to making tens of millions of tests available to the federal government.

Siemens Healthineers is also supplying millions of additional tests to state government programs and non-profit organizations.

Siemens Healthineers is also supplying antigen tests to healthcare facilities across the country to ensure that front-line workers can continue to care for patients in a safe manner.

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

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

The ability of the test to produce a positive result in those infected with SARS-CoV-2 according to the PCR reference method is defined as sensitivity, and the ability to produce a negative result in those who are not currently infected with SARS-CoV-2 is defined as specificity.

All clinical data has been established under Siemens Healthineers participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics’ (RADx) Independent Test Assessment Program (ITAP).

Siemens Healthineers has established itself as a reliable source of diagnostic assays to aid in the fight against the COVID-19 pandemic.

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, in addition to antibody, antigen, and molecular SARS-CoV-2 tests.

Hematology, coagulation, cardiac, respiratory, inflammation, and infectious disease panels are among the company’s diverse offerings.

Siemens Healthineers’ blood gas testing and imaging solutions provide actionable results that assist clinicians in caring for COVID-19 patients.

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