- The FDA grants Bio-Rad Laboratories Emergency Use Authorization (EUA) for the company’s severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Total Ab test.
- This test is the first total antibody test that has received an EUA from the FDA.
A recently published article in Contagion Live elaborates on the purpose of blood-based immunoassay test.
What is the purpose of this test?
The test will to help clinicians identify whether an individual has antibodies against SARS-CoV-2. It is a virus associated with coronavirus disease 2019 (COVID-19). The test will used on both manual and an automated immunoassay platform.
Clinical evaluation of the SARS-CoV-2 Total Ab test
In the clinical evaluation of the SARS-CoV-2 Total Ab test, it presented diagnostic specificity of more than 99% and diagnostic sensitivity of 98%. Furthermore, when researchers conducted cross-reactivity testing, they found the test presented specificity of 100%. The results also showed no reactivity against other interfering specimens, including non-CoV-2 coronaviruses.
“The total antibody approach enables detection of antibodies in the majority of patients eight days after the onset of symptoms, versus an IgG-only approach,” said Dara Wright, MBA, Bio-Rad Clinical Diagnostics group EVP and president, in a press release. “We are pleased to have received FDA Emergency Use Authorization for our SARS-CoV-2 Total Antibody test to support COVID-19 diagnosis.”
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Source: Contagion Live
