The novel test facilitates the semi-quantitative automatable detection of the SARS-CoV-2 nucleocapsid protein on a large scale
EUROIMMUN has introduced CE marked SARS-CoV-2 antigen ELISA test. (Credit: EUROIMMUN Medizinische Labordiagnostika AG)
PerkinElmer Inc.’s EUROIMMUN has introduced a new laboratory test called Antigen ELISA for the detection of SARS-CoV-2 protein in acutely infected patients in the CE mark accepting countries.
The CE marked SARS-CoV-2 antigen ELISA test has been designed for the semi-quantitative automatable detection of the SARS-CoV-2 nucleocapsid protein on a large scale.
Part of EUROIMMUN’s broad Covid-19 product portfolio, the novel test is said to support acute Covid-19 diagnostics following the two molecular diagnostic systems such as EURORealTime SARS-CoV-2 and EURORealTime SARS-CoV-2/Influenza A/B.
Validated for swab sample material from the upper respiratory tract, the test will help test individuals with acute symptoms that point to Covid-19 or who have had suspected contact with SARS-CoV-2.
According to the company, validation data between the results achieved through Antigen ELISA and a real-time PCR test for detecting the virus showed 93.6% positive agreement (sensitivity) and 100% negative agreement (specificity).
The SARS-CoV-2 antigen assay, which is founded on the familiar ELISA technology, can be conducted in most diagnostic laboratories and automatically processed on all open ELISA platforms.
EUROIMMUN CEO Dr Wolfgang Schlumberger said: “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.”
Recently, EUROIMMUN has secured the CE mark of approval for its new polymerase chain reaction (PCR) test to differentiate between Covid-19 and flu.