NEW YORK ─ Eurofins Technologies said on Wednesday that it has received CE-IVD marking for its Ingezim COVID 19 DR total antibody assay for the indirect diagnosis of past exposure to SARS-CoV-2.
The test is a dual recognition enzyme-linked immunosorbent assay (ELISA) that can detect total SARS-CoV-2 virus nucleoprotein-specific antibodies, including IgG, IgM, and IgA, without differentiating between them.
The assay uses the SARS-CoV-2 nucleoprotein (N protein) ─ one of the virus' most abundant early-onset proteins ─ as an antigen for the detection of antibodies against SARS-CoV-2, according to Budapest-based Eurofins Technologies, a subsidiary of Eurofins Scientific.
Its test can be used for the early detection of SARS-CoV-2-specific antibodies, the firm said, noting the assay favors the detection of IgM due to its ability to capture more than one conjugated N-protein molecule.
Validation using 332 serum samples confirmed an analytical sensitivity of 100 percent and specificity of 99.2 percent 17 days after the onset of symptoms, and 85 percent sensitivity between seven and 16 days after the onset of symptoms.
Eurofins said its Ingezim COVID 19 DR kits are compatible with various open-platform ELISA analyzers. Eurofins Ingenasa, a Eurofins Technologies company, led the development of the assay.
In April, Eurofins Technologies companies NovaTec, Virotech, and Gold Standard Diagnostics launched serological tests for the separate determination of IgG, IgM, and IgA antibodies.
The company said in May that it had received CE-IVD marking for the GSD NovaPrime SARS-CoV-2 (COVID-19) assay, a multiplex RT-PCR test that simultaneously detects two target sequences inside the SARS-CoV-2 N gene, providing results in about two hours.