Bio-Rad Granted Authorization to Sell or Import the Platelia SARS-CoV-2 Total Ab Test for COVID-19 Testing in Canada

Date: 
11/18/2020

HERCULES, Calif. – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it has been granted authorization to sell or import the Platelia SARS-CoV-2 Total Ab test in Canada. The blood-based immunoassay kit is used to help determine if an individual has developed antibodies to SARS-CoV-2, the virus associated with COVID-19.

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 immunoglobulin. 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 for patients tested more than eight days after onset of symptoms. 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 outbreaks of COVID-19.

"We are pleased to provide a Platelia SARS-CoV-2 Total Ab test to support COVID-19 diagnosis and population screening in Canada," said Yves Beaulieu, Director & Commercial Manager, Bio-Rad Laboratories Canada Ltd. "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.

To learn more about how Bio-Rad products are being used in the fight against COVID-19, please visit our Newsroom at bio-rad.com.

About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology and pharmaceutical companies, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,000 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019. For more information, please visit bio-rad.com.

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