FDA EUA: Siemens Healthineers CLINITEST® Rapid COVID-19 Antigen Self-Test

FDA Emergency Use Authorization Siemens Healthineers CLINITEST® Rapid COVID-19 Antigen Self-Test, a Healgen Scientific Manufactured Product


Healgen Scientific, LLC. is proud to announce, through a partnership with Siemens Healthineers, that the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the CLINITEST® Rapid COVID-19 Antigen Self-Test. The now authorized CLINITEST® Rapid COVID-19 Antigen Self-Test provides a reliable option for both at-home and over-the-counter self-testing to the US public.


Siemens holds exclusive rights for distribution of the Healgen Scientific, LLC manufactured CLINITEST® Rapid COVID-19 Antigen Self-Test within the US. Throughout the pandemic, Healgen Scientific, LLC, with Siemens Healthineers, has reliably supplied millions of high quality COVID-19 antigen tests worldwide since late 2020. At present, production capacity is upward and increasing daily. “To address global demands for COVID-19 antigen testing during the pandemic Healgen has expanded manufacturing capacity while maintaining our high-quality product standards” stated Bryan Fang, President of Healgen Scientific, LLC.


The CLINITEST® Rapid COVID-19 Antigen Self-Test provides a visually read, qualitative result within 15 minutes. The test is intended for non-prescription home use to determine active infection of COVID-19. Testing can be performed by unsupervised individuals, aged 14 or older, or adult-collected samples from individuals ages 2-13.


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). The evaluation involved prospective collection and testing of clinical samples, where the antigen test result was compared against a Polymerase Chain Reaction (PCR) test. Validation outcome met FDA’s standards, resulting in a sensitivity of 86.5%, specificity of 99.3% and overall accuracy of 92.9%.


Healgen Scientific, LLC is committed to continually provide quality and innovative diagnostic testing platforms for at-home and professional settings in an effort to enhance global health. Healgen Scientific, LLC has a broad and diversified test portfolio, which ranges from infectious disease, toxicology, women’s health, tumor markers and cardiac markers.


For further information on the CLINITEST Rapid COVID-19 Antigen Self-Test, visit www.clinitest.siemens-healthineers.com/US


For further information on Healgen Scientific, LLC.visit www.healgen.com


 

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 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.