
Agilent completed CE-IVD registration of qRT-PCR In vitro diagnostic kit for SARS-CoV-2 RNA detection
On Mar. 9, 2021, Agilent Technologies announced the launch of a real-time reverse transcription (qRT) PCR-based diagnostic kit for the detection of SARS-CoV-2 RNA. The CE-IVD mark is in accordance with the European Union In Vitro Diagnostic Directive 98/79/EC and is available for immediate distribution.
The Agilent SARS-CoV-2 qRT-PCR Dx kit is a real-time reverse transcriptase PCR (qRT-PCR) IVD reagent kit for the detection of SARS-CoV-2 RNA. Agilent’s kit is intended for the qualitative detection of CDC-recommended1 N1 and N2 targets from SARS-CoV-2 RNA isolated and purified from nasopharyngeal swab specimens. The single-tube assay provides greater efficiency, higher throughput, less consumable usage, and delivers unambiguous results for confidence in testing outcomes.
The Agilent SARS-CoV-2 qRT-PCR Dx kit has been designed for flexibility across the entire workflow. The open system has been validated with a variety of commercially available RNA extraction products and multiple real-time PCR systems, which may reduce the need to purchase new analytical equipment and allows labs to bring testing online faster. The convenient easy-to-use format requires minimal manual work, may reduce the potential for human error, and be amenable to automation to fit any laboratory’s throughput needs. The kit is also configured so that primers/probes and positive controls can be purchased together or separately.
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Source: Agilent Technologies
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