Raritan-based Ortho Clinical Diagnostics became one of the first to have its quantitative COVID-19 IgG antibody test receive emergency use authorization from the U.S. Food and Drug Administration, the company said Monday.
Ortho’s new quantitative COVID-19 IgG antibody test targets the S1 spike protein and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test offers 100% specificity and excellent sensitivity, the company said.
The company said the test is calibrated to the international standards by the World Health Organization for anti-SARS-CoV-2 IgG antibodies, which gives clinicians and public health leaders a standard tool to measure antibody response to SARS-CoV-2. 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.
Ortho is one of the world’s largest pure-play in vitro diagnostics companies.
Dr. Ivan Salgo, head of medical, clinical, and scientific affairs at Ortho, was obviously thrilled.
“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,” he said. “Ortho’s quantitative COVID-19 IgG antibody test, which targets the spike protein, is an important tool to help health care and policy teams to understand long-term antibody responses to SARS-CoV-2.”