Takara Bio Europe SAS launches an in vitro diagnostic assay for the detection of SARS-CoV-2

Takara Bio Europe SAS (TBE SAS) announced the launch of an in vitro real-time reverse transcriptase PCR (RT-qPCR-based) diagnostic assay for the qualitative detection of novel coronavirus (SARS-CoV-2) from patients suspected of having COVID-19. This CE-IVD kit complies with the Directive 98/79/EC on in vitro medical devices and is available for immediate distribution in selected countries.

The Takara SARS-CoV-2 Direct PCR detection kit, approved in Japan last year as an in vitro diagnostic kit, is designed to detect SARS-CoV-2 in a simpler and faster manner. Nasopharyngeal or nasal swab samples, or crude saliva samples, can be processed directly with this assay without RNA extraction, thus streamlining the protocol and giving a result in just 60 minutes.

This kit contains two primer/probe sets specific to the regions of the SARS-CoV-2 nucleocapsid genes (N1 and N2), based on the sequences reported by the Centers for Disease Control and Prevention (CDC). It also includes a primer/probe set to detect the human RNase P (RP) gene as an internal control. The Takara SARS-CoV-2 Direct PCR detection kit uses Takara Bio’s world-renowned enzymes to offer reliable results that clinicians can trust. The kit’s simple yet efficient protocol has been tested and validated on commonly used thermal cyclers. It can accommodate a wide range of samples, making it a versatile and economical solution for all laboratories.

With this kit, TBE SAS is proud to support governments, medical staff, and scientists in their fight against the COVID-19 pandemic and contribute to developing innovative solutions for the diagnosis of respiratory diseases.

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