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Eurofins Technologies Obtains CE Marks for SARS-CoV-2, Flu, RSV RT-PCR Kits

NEW YORK ─ Eurofins Technologies on Wednesday announced it has launched and obtained CE marking for two multiplex RT-PCR assays to diagnose respiratory diseases caused by SARS-CoV-2, the influenza virus, and respiratory syncytial virus.

Eurofins' Mplex SARS-CoV-2+, Flu A, Flu B (C1) RT-PCR assay uses a single reaction to differentiate between influenza A, influenza B, and SARS-CoV-2. It simultaneously detects two SARS-CoV-2 targets — the N gene and RNA‑dependent RNA polymerase, or RdRP, gene. Meanwhile, the RSV A, RSV B RT-PCR assay differentiates between respiratory syncytial virus A and B, the firm said.

The Budapest, Hungary-based firm added that both kits can be processed in parallel on the same plate using the same temperature profile and provide results in approximately one hour, and they can detect and differentiate between SARS-CoV-2, influenza, and RSV viral infections in the same PCR run.

An internal control, RNaseP, is included for sample processing and to monitor RNA extraction and the presence of potential inhibitors in the RT-PCR reaction, the firm said.

Eurofins added that Agilent Technologies' AriaDx and AriaMx thermocyclers are validated for both assays. Thermo Fisher Scientific's Applied Biosystems ABI Prism 7500 Fast SDS and QuantStudio; Bio-Rad Laboratories' CFX96 Touch; and Roche's LightCycler 480 II are thermocyclers validated for the RSV A, RSV B RT-PCR kit.