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Agilent Receives CE Mark for SARS-CoV-2 PCR Test

NEW YORK – Agilent Technologies said on Tuesday that it has received a CE mark for its SARS-CoV-2 reverse transcriptase quantitative PCR Dx kit and launched the test in Europe.   

The Agilent SARS-CoV-2 qRT-PCR Dx kit detects N1 and N2 targets from SARS-CoV-2 RNA isolated and purified from nasopharyngeal swab specimens.

Agilent said that the test has been validated with a variety of commercially available RNA extraction products and several real-time PCR systems, which will potentially reduce the need to purchase new analytical equipment and allows labs to bring testing online faster. The firm believes the test's format requires minimal manual work, reduces the potential for human error, and is amenable to automation to fit any laboratory's throughput needs.

Agilent noted that the single-tube assay provides greater efficiency, higher throughput, less consumable usage, and delivers clear results in testing outcomes. Users can purchase the kit together or separately with primers and positive controls.

"As the global community enters the second year of the pandemic, the need for accessible and reliable direct diagnostic tests continues to grow, even as vaccine availability to the public improves," Sam Raha, president of Agilent's Diagnostic and Genomics Group, said in a statement. "Fast and reliable detection kits remain a critical tool in the ongoing effort to control the pandemic."

Agilent, which released its SARS-CoV-2 IgG ELISA kit last month, believes both assays support a combined approach to addressing the pandemic through direct virus detection and post-infection immune response.