Siemens Lab-Based SARS-CoV-2 Antigen Assay (CoV2Ag) Obtains CE Mark for Use with Its High-Throughput Analyzers

Siemens Healthineers’ (Erlangen, Germany) laboratory-based SARS-CoV-2 Antigen Assay (CoV2Ag) has obtained CE Mark and is now offered for the Atellica Solution and ADVIA Centaur analyzers, widely available in laboratories worldwide.

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. The test has been submitted to the FDA for Emergency Use Authorization. The antigen test detects the nucleocapsid antigen and has been designed with five monoclonal antibodies with the objective to maximize its sensitivity to both current and future SARS-CoV-2 variants. It also offers a leading time-to-result for lab-based antigen tests, making it an ideal tool to test large quantities of patient samples quickly. Additionally, the test helps protect laboratory staff from the virus with a pretreatment process, which inactivates the virus without compromising the quality or validity of patient test results.

The Siemens Healthineers' CoV2Ag test shows strong alignment to molecular RT-PCR methods with sensitivity exceeding 94% and specificity at 100% 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 significantly increase the SARS-CoV-2 testing capacity with a platform that 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, making this a cost effective solution to detect infection when high throughput is critical. Such 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.

"SARS-CoV-2 antigen testing is a critical tool to help support the fight against COVID-19 and identify infected individuals, including those who are asymptomatic," said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. "High-throughput SARS-CoV-2 antigen testing can help laboratories rapidly scale their SARS-CoV-2 diagnostic testing capacity. The Siemens Healthineers' antigen test offers fast pretreatment time and time to results."