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Siemens Healthineers, Advaite Get FDA Emergency Use Authorizations for Coronavirus Antibody Tests

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for SARS-CoV-2 antibody tests developed by Siemens Healthineers and Advaite.

Separately, Siemens said on Tuesday that it has received CE marking for the use of its Clinitest Rapid COVID-19 Antigen Test with an additional specimen type.

Siemens' Dimension Vista SARS‑CoV‑2 IgG (COV2G) a luminescent oxygen channeling immunoassay (LOCI) designed for the qualitative and semiquantitative detection of immunoglobulin G (IgG) against SARS-CoV-2 in serum and plasma. It runs on Siemens' Dimension Vista and provides results in around 15 minutes, according to the Erlangen, Germany-based company.

Siemens' Dimension EXL SARS‑CoV‑2 IgG (CV2G) is also based on LOCI technology and is intended for the qualitative and semiquantitative detection of IgG against SARS-CoV-2 in serum and plasma. It runs on Siemens' Dimension EXL with LOCI Module integrated chemistry system

Both tests may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, the FDA said.

Advaite's RapCov Rapid COVID-19 Test is designed to detect IgG against SARS-CoV-2 using a fingerstick blood sample in point-of-care settings, the Malvern, Pennsylvania-based company said. It provides results within 15 minutes.

Siemens' point-of-care Clinitest Rapid COVID-19 Antigen Test received a CE mark last year for use with nasopharyngeal swabs. The company said on Tuesday that it has now been CE marked for use with easier-to-collect anterior nasal swabs. 

Earlier this month, Siemens received EUA from the FDA for a test designed to detect an interleukin-6 inflammatory response in COVID-19 patients.