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Amidst the unprecedented fear of Coronavirus (COVID-19), Bio-Rad Laboratories, Inc. has announced the launch of a SARS CoV-2 standard to underpin laboratory assay validation of COVID-19 testing. The testing will be part of its Exact Diagnostics product line as the company is offering the SARS CoV-2 standard to aid labs to expedite access to testing and authenticate their COVID-19 assay results.
The SARS CoV-2 standard has human genomic DNA and synthetic COVID-19 RNA transcripts, thereby enabling laboratories to test the total process of a molecular assay such as amplification, extraction and detection of the virus.
It is worth noting that the (CLIA) Clinical Laboratory Improvement Amendments federal regulatory standards need clinical laboratories to document and build their own specifications of performance meant for test developed in laboratory to make precise and accurate results before the test is implemented.
Dara Wright, Bio-Rad Executive Vice President, highlighted the significance of labs to have access to aptly-defined standards to assist with the authentication of the tests in case of a public health emergency.
Wright stressed that the SARS CoV-2 standard assists laboratories to keep up with the soaring demand for the identification of Coronavirus by helping validate COVID-19 tests.
The press release shared by Bio-Rad states that the Exact Diagnostics product line develops and manufactures an array of innovatively designed molecular diagnostics products to keep abreast with the needs of quality control of assay manufacturers and clinal labs.
Underpinned by offering quality products and services to labs and manufacturers, the diagnostic products intend to improve patient care by helping to assure the validity of screening tests and diagnostic results.
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