NEW YORK – The US Food and Drug Administration said on Monday that it issued Emergency Use Authorization for PerkinElmer's Euroimmun's Anti-SARS-CoV-2 ELISA test, the first serology test whose results were independently validated by the federal government.
The test qualitatively detects IgG antibodies against the coronavirus in human serum and plasma and is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, the FDA said.
In a statement on Tuesday, PerkinElmer said that Euroimmun is able to manufacture millions of assays each month and since March it has been shipping its Anti-SARS-CoV-2 ELISA (IgG) assay to labs worldwide. Euroimmun will further increase its production capacity to meet demand, Waltham, Massachusetts-based PerkinElmer added.
"It is possible that 50 percent or more of people who have been infected with COVID-19 might not display symptoms, making it difficult to identify those who have previously contracted COVID-19," PerkinElmer President and CEO Prahlad Singh said in the firm's statement. "That’s why serological testing that utilizes an antigen highly specific to SARS-CoV-2 is such an important tool in understanding how pervasive this virus is."
It is the 12th serology test for the coronavirus to receive EUA from the FDA and the first to receive such designation following moves by the agency to more stringently parse such tests amid concerns about their performance. Issues around false negatives and false positives have raised questions about the clinical utility of coronavirus antibody tests, and as test makers began to flood the market with SARS-CoV-2 serology tests – after the FDA said in mid-March they would allow such tests to be marketed without requiring the companies to first receive EUA for them – blowback against the tests, and what some said was lax oversight by the FDA, began to mount.
In response, the FDA announced in early April an interagency group had been formed to validate serology tests. Later the same month, it added that it would work with the National Cancer Institute and National Institute of Allergy and Infectious Diseases to validate serology tests to detect COVID-19. Last week, the FDA announced a new so-called "umbrella" pathway for serology tests to receive EUA.
Most recently, the agency on Monday issued new guidance saying it would no longer allow test makers to just notify the FDA of their intent to market such tests. Instead, they would have to file for EUA and meet certain performance thresholds.
For Euroimmun's test, the FDA said validation was done at the Frederick National Laboratory for Cancer Research, a federally funded research and development center sponsored by the NCI. It added that the results are among the first resulting from a collaboration between the FDA, National Institutes of Health, Centers for Disease Control and Prevention, and the Department of Health and Human Service's Biomedical Advanced Research and Development Authority to assess certain serology tests for the coronavirus. Essential samples and materials used in the evaluation were provided by the NIAID, the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, and the Vitalant Research Institute.
In late March, Eurommun's Anti-SARS-CoV-2 ELISA tests for immunoglobulin classes A and G received the CE mark. The same month, PerkinElmer received EUA from the FDA for its coronavirus RT-PCR test.