Bio-Rad Laboratories is accelerating production of its Platelia SARS-CoV-2 Total Ab test, a blood-based immunoassay kit to help determine if an individual has developed antibodies to SARS-CoV-2, the virus associated with COVID-19 disease.
Bio-Rad launched the test in late April. Soon after, the test was granted US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA), the first total antibody test to receive EUA from the FDA. Bio-Rad’s Platelia SARS-CoV-2 Total Ab test has also met CE-mark requirements for Europe, and it was validated by the Centre National de Référence, Paris, to be included in the official list of serological tests recommended by the French government for the detection of SARS-CoV-2.
The Platelia SARS-CoV-2 Total Ab test can help clinicians identify if an individual has been infected by SARS-CoV-2 and therefore has developed an immune response against the virus. The test detects three types of antibody (IgG, IgM, and IgA), an approach that appears to be more sensitive than assays against a single immunoglobulin.
Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99% and diagnostic sensitivity of 100%. Cross-reactivity testing demonstrated specificity of 100% with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.
Broad-based antibody testing can provide a more complete picture of infection rates and immunity to help public health officials in their efforts to reduce containment orders and better manage a potential second wave of COVID-19.