Bio-Rad Laboratories has announced it's Platelia SARS-CoV-2 Total Ab assay has been granted Emergency use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). It is the first total antibody test to be given EUA.
Bio-Rad's blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2, the virus associated with COVID-19 disease. The test has also met the CE mark requirements for Europe.
Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99% and diagnostic sensitivity of 98%. Cross-reactivity testing showed a specificity of 100% with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.
The SARS-CoV-2 Total Ab test can be used manually or on an automated immunoassay platform, such as Bio-Rad's EVOLIS System, which offers high throughput processing and sample traceability.
Note: This content has been edited by a rapidmicrobiology staff writer for style and content.
