CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
May 6, 2020—Bio-Rad Laboratories announced it was granted FDA emergency use authorization for the company’s SARS-CoV-2 Total Ab test, a blood-based immunoassay that aims to help clinicians identify if an individual has developed antibodies against SARS-CoV-2. 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 percent and diagnostic sensitivity of 98 percent. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses, the company reports.
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.