Siemens Healthineers announced today the company's laboratory-based SARS-CoV-2 Antigen Assay (CoV2Ag)1 obtained CE Mark and is now offered for the Atellica® Solution and ADVIA Centaur® analyzers, widely available in laboratories worldwide. 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. 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 universities. In addition to speed and reliability, the test is further characterized by a pretreatment process that helps protect laboratory staff from the virus. It inactivates the virus without compromising the quality or validity of patient test results.
The Siemens Healthineers' COV2Ag test shows strong alignment compared with on the market available automated real-time (RT)-PCR testing with sensitivity exceeding 94% and specificity at 100% for the Atellica COV2Ag test.2 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.3
Other benefits of lab-based, automated antigen testing include simplified pre-analytics and a more economical cost per test, making this a cost effective solution to detect infection when high throughput is critical.
"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."
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.
Siemens Healthineers has distinguished itself as a provider of quality assays to aid the COVID-19 pandemic. In addition to antibody, antigen, and molecular SARS-CoV-2 tests, Siemens Healthineers offers a broad diagnostics portfolio to aid in the prognosis, treatment and follow-up of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. 75A50121P00005.
This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary from country to country and is subject to varying regulatory requirements.
Based on PCR results obtained from symptomatic and asymptomatic patients with the FTD SARS-CoV-2 PCR method. Percent positive agreement with PCR Ct<30 samples (relative sensitivity) was 96.07%, and percent negative agreement with PCR negative samples (relative specificity) was 100%.
Dependent upon text mix.