NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for Bio-Rad Laboratories' Platelia Total Ab immunoassay for SARS-CoV-2.
The assay is designed to detect all human antibodies against SARS-CoV-2 — including immunoglobulin M, immunoglobulin A, and immunoglobulin G — in serum and plasma in order to diagnose recent or prior infections. It may be used by any lab CLIA certified to perform high-complexity tests either manually or on automated immunoassay platforms.
According to Bio-Rad, the assay has demonstrated over 99 percent specificity and 98 percent sensitivity in clinical testing. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses, the Hercules, California-based company said.
Bio-Rad noted that the Platelia Total Ab immunoassay has also met CE mark requirements.