Automatable and reliable COVID-19 test rounds out Company’s menu of offerings for acute diagnostics of the virus
16/12/2020 — WALTHAM, Mass. — (BUSINESS WIRE)
EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked SARS-CoV-2 Antigen ELISA for specific determination of the SARS-CoV-2 protein. The assay adds to the Company’s broad product portfolio for COVID-19 diagnostics and supports the molecular PCR tests to aid in diagnosing acute SARS-CoV-2 infections.
The Antigen ELISA is a laboratory test able to be applied in semi quantitative automatable detection of the SARS-CoV-2 nucleocapsid protein on a large scale. It is validated for swab sample material from the upper respiratory tract and is useful for testing individuals with acute symptoms that point to COVID-19 or who have had suspected contact with SARS-CoV-2. Validation data revealed 93.6% positive agreement (sensitivity) and 100% negative agreement (specificity) between results obtained with the Antigen ELISA and those obtained with a real time PCR test for detecting the virus. Based on the well-known ELISA technology, the SARS-CoV-2 Antigen assay can be performed in most diagnostic laboratory settings and automatically processed on all open ELISA platforms.
“Infection numbers are continuously increasing, and there is enormous pressure to provide sufficient test capacities. The availability of gold-standard PCR testing, however, is often challenged in acute COVID-19 outbreak situations. That’s why a reliable and automatable antigen detection test as our new ELISA can be a valuable supplement to help rapid identification of acutely infected individuals,” says Dr. Wolfgang Schlumberger, CEO of EUROIMMUN.
The SARS-CoV-2 Antigen ELISA is available in countries that recognize CE marking. Validation of saliva specimens for use with this assay is currently in process.
The assay is the latest of the comprehensive EUROIMMUN COVID-19 product portfolio and the third test to support acute COVID-19 diagnostics following the two molecular diagnostic systems: EURORealTime SARS-CoV-2 and EURORealTime SARS-CoV-2/Influenza A/B.
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.