HERCULES, Calif. – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced the launch of its in vitro diagnostics VIROTROL SARS-CoV-2 and VIROCLEAR SARS-CoV-2 positive and negative quality controls for use in antibody testing of SARS-CoV-2, the virus associated with COVID-19. The serological controls are available for in vitro assay procedures in the U.S. and have met the CE mark requirements for in vitro diagnostics in markets outside the U.S.
VIROTROL SARS-CoV-2 quality controls are independent, positive controls designed to detect if patients have the antibodies for SARS-CoV-2. These controls can detect SARS-CoV-2 total IgM and IgG antibodies across all testing procedures. Routine use of VIROTROL SARS-CoV-2 controls provide laboratories with an unbiased independent assessment of the laboratory’s test system for greater confidence in patient test results. The controls are available in three classes, each targeted to specific levels of the SARS-CoV-2 antibodies to match the range of commercially available assays.
The VIROCLEAR SARS-CoV-2 can be used as a negative control across all SARS-CoV-2 antibody assays and methodologies and have been demonstrated to be free of any of the SARS-CoV-2 antibodies for that purpose.
"Robust and precise testing of samples for COVID-19 is more critical than ever," said Dara Wright, Bio-Rad Executive Vice President, President, Clinical Diagnostics Group. “Our VIROTROL SARS-CoV-2 and VIROCLEAR SARS-CoV-2 quality controls provide clinical labs a way to monitor their laboratory testing procedures to ensure the lab can provide reliable patient results across their test platforms."
Bio-Rad provides a full suite of controls to support both molecular and antibody-based assays for COVID-19 testing. In addition to the VIROTROL SARS-CoV-2 and VIROCLEAR SARS-CoV-2 controls, the company offers a SARS CoV-2 Standard to support laboratory assay validation and run control of COVID-19 molecular testing through Bio-Rad’s Exact Diagnostics product line.
The Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards require clinical laboratories to establish and document their own performance specifications for laboratory-developed tests to ensure accurate and precise results prior to the implementation of the test.
Please visit https://qcnet.com/infectiousdisease/anitbodycontrol.html for further information.
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.
This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding our expectations about our products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include the duration and severity of the COVID-19 pandemic, our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in Bio-Rad’s public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.
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