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FDA Authorizes Ortho Clinical’s COVID-19 Antibody Test
The VITROS Anti-SARS-CoV- IgG Quantitative Test targets the S1 spike protein and is the first COVID-19antibody test to receive FDA emergency use authorization.
FDA recently granted emergency use authorization to Ortho Clinical Diagnostics’ COVID-19 antibody test for use as an aid in identifying individuals with adaptive immune responses to the virus.
The VITROS Anti-SARS-CoV- IgG Quantitative Test targets the S1 spike protein. Itis the first COVID-19 IgG antibody test to receive emergency use authorization.
Notably, the test is the only antibody test calibrated to the World Health Organization (WHO) Standard for anti-SARS-CoV-2 IgG antibodies.
"The development of the VITROS Anti-SARS-CoV-2 IgG Quantitative Test shows Ortho's leadership in response to the need for standardization of SARS-CoV-2 serological methods currently used," Ivan Salgo, MD, head of medical, clinical, and scientific affairs at Ortho, said in the announcement.
"Ortho's quantitative COVID-19 IgG antibody test is an important tool to help health care and policy teams to understand long-term antibody responses to SARS-CoV-2,” Salgo continued.
The VITROS COVID-19 performance dashboard allows labs to view COVID-19 antibody testing data for more informed decisions. The system also provides information regarding Ortho analyzers, test volumes, HIT levels, and reagent efficiency.
“This uniform data is a first step toward understanding the rise and fall of antibodies in individuals and the long-term impacts of the COVID-19 pandemic on communities and the overall population,” an Ortho spokesperson said.
In May, Ortho partnered with Quest Diagnostics to expand COVID-19 antibody testing to more than 20 Quest laboratories across the US.
As part of the collaboration, Ortho provided its VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test to test patients for detectable levels of SARS-CoV-2 antibodies. The test offers 100 percent specificity, helping to prevent false positives.
At the same time, the company launched the VITROS Anti-SARS-CoV-IgG Quantitative Antibody test in addition to a total COVID-19 nucleocapsid antibody test.
Ortho is the only company that offers laboratories in the US a quantitative test in combination with a nucleocapsid test. Both tests help healthcare teams differentiate antibodies against COVID-19.
FDA issued the first emergency use authorization for a COVID-19 antigen test to Quindel Corporation’s Sofia 2 SARS Antigen FIA in May 2020.
Since then, FDA has granted emergency use authorization for Quest Diagnostics’ sample COVID-19 pooled testing tool, Abbott’s SARS-CoV-2 lab-based serology blood test, and Yale’s COVID-19 test.
