CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
June 2020—Bio-Rad Laboratories announced it was granted FDA emergency use authorization for the company’s SARS-CoV-2 Total Ab test. 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 test can be used manually or on an automated immunoassay platform, such as Bio-Rad’s Evolis system.
In a separate release, the company announced its SARS-CoV-2 Droplet Digital PCR test kit has been granted emergency use authorization.
Pages: 1 2