January 2022—Siemens Healthineers announced that the company’s SARS-CoV-2 tests are designed to detect the omicron variant. The company evaluated the potential impact of the variant on the Clinitest Rapid COVID-19 antigen test; the FTD SARS-CoV-2 assay, a PCR test; and the Atellica IM/Advia Centaur SARS-CoV-2 antigen assay (CoV2Ag).
To assess the potential impact of the Clinitest rapid test and the CoV2Ag assay, Siemens’ R&D team analyzed the sequence data of the omicron variant nucleocapsid protein, which demonstrated greater than 98 percent sequence homology of the nucleocapsid protein to other SARS-CoV-2 variants. The Clinitest Rapid COVID-19 Antigen Self-Test has a sensitivity of 97.25 percent and a specificity of 100 percent compared with a PCR, or nucleic acid-detection method, and provides results in 15 minutes.
The CoV2Ag test shows strong alignment compared with automated RT-PCR testing, with sensitivity exceeding 96 percent and specificity exceeding 99 percent for the Atellica CoV2Ag test. The Atellica IM analyzer can run up to 440 tests per hour.