HERCULES, Calif.–June 30, 2020 –Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products 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 commercially launched the test in late April. Soon after, the test was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorization (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 the 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 antibodies: IgG, IgM, and IgA, an approach that appears to be more sensitive than assays against a single immunoglobulin1. Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 100 percent. Cross-reactivity testing demonstrated specificity of 100 percent 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.
“We are pleased to provide a Platelia SARS-CoV-2 Total Ab test to support COVID-19 diagnosis and population screening,” said Jean-François Mouscadet, Bio-Rad Associate Vice President, R&D, Clinical Diagnostics, Europe. “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,” he said.
The Platelia 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.
Bio-Rad provides a wide range of products for use in the support of COVID-19 diagnostic screening, confirmation of test results, surveillance, as well as for therapy and vaccine research and development. From molecular testing using real-time PCR or Droplet Digital PCR, to immunology assays, our wide range of solutions provide best in class sensitivity and accuracy.
To learn more about how Bio-Rad products are being used in the fight against COVID-19, please visit bio-rad.com.
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