Siemens Healthineers announced that the company's laboratory-based SARS-CoV-2 Antigen Assay (CoV2Ag) obtained CE Mark and is now offered for the Atellica Solution and ADVIA Centaur analyzers, according to a news release. The company also has submitted the test to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA).
The antigen test detects the nucleocapsid antigen and has been designed with five monoclonal antibodies with the objective of maximizing its sensitivity to both current and future SARS-CoV-2 variants.
Siemens Healthineers said its CoV2Ag test shows strong alignment to molecular RT-PCR methods with sensitivity exceeding 94 percent and specificity at 100 percent for the Atellica COVAg test. While molecular RT-PCR diagnostic testing is the gold standard in accuracy, it lacks the high throughput capability of a lab-based, automated antigen test. With availability of CoV2Ag on the Atellica IM Analyzer, laboratories can run up to 440 tests per hour.
Other benefits of lab-based, automated antigen testing include simplified pre-analytics and a more economical cost per test compared with RT-PCR testing. Siemens Healthineers said the testing could be deployed at on-site collection centers for hospital staff, patients and visitors, remote collection facilities for large scale testing of local populations or in dedicated, pop-up labs at airports or large universities.
The CoV2Ag assay is for in vitro diagnostic use in the qualitative detection of SARS-CoV-2 in nasopharyngeal swab and nasal swab specimens within the first seven days of symptom onset, or from asymptomatic individuals, using the Atellica IM Analyzer or ADVIA Centaur XP and ADVIA Centaur XPT immunoassay Systems.
