Bio-Rad Launches SARS CoV-2 Standard for Coronavirus (COVID-19) Testing
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By HospiMedica International staff writers Posted on 19 Mar 2020 |
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Image: SARS CoV-2 Standard (Photo courtesy of Bio-Rad Laboratories, Inc.)
Bio-Rad Laboratories, Inc. (Hercules, CA, USA) has launched a SARS CoV-2 Standard to support laboratory assay validation of coronavirus (COVID-19) testing through its Exact Diagnostics product line. Bio-Rad is providing the SARS CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing.
Bio-Rad develops, manufactures, and markets a broad range of innovative products for the life science research and clinical diagnostic markets. Its customers comprise university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality.
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. The SARS CoV-2 Standard contains synthetic COVID-19 RNA transcripts and human genomic DNA, allowing laboratories to test the entire process of a molecular assay including extraction, amplification, and detection of the virus.
"In a public health emergency, it is critical that labs have access to well-defined standards to help with the validation of their tests," said Dara Wright, Bio-Rad Executive Vice President, President, Clinical Diagnostics Group. "The SARS CoV-2 Standard helps to validate COVID-19 tests, which enables more laboratories to meet the growing demand for identification of this coronavirus."
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Bio-Rad Laboratories, Inc.
Bio-Rad develops, manufactures, and markets a broad range of innovative products for the life science research and clinical diagnostic markets. Its customers comprise university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality.
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. The SARS CoV-2 Standard contains synthetic COVID-19 RNA transcripts and human genomic DNA, allowing laboratories to test the entire process of a molecular assay including extraction, amplification, and detection of the virus.
"In a public health emergency, it is critical that labs have access to well-defined standards to help with the validation of their tests," said Dara Wright, Bio-Rad Executive Vice President, President, Clinical Diagnostics Group. "The SARS CoV-2 Standard helps to validate COVID-19 tests, which enables more laboratories to meet the growing demand for identification of this coronavirus."
Related Links:
Bio-Rad Laboratories, Inc.
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