Takara Bio Europe (TBE) has announced the launch of an in vitro diagnostic assay for the qualitative detection of novel coronavirus (SARS-CoV-2) from patients suspected of having Covid-19, based on real-time reverse transcriptase PCR (RT-qPCR). 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, which was approved in Japan last year as an in vitro diagnostic kit, has been designed to detect SARS-CoV-2 in a simpler and faster manner. Nasopharyngeal or nasal swab samples, along with 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 Center for Diseases Control and Prevention (CDC). It also includes a primer/probe set to detect the human RNase P (RP) gene as an internal control. The detection kit uses Takara Bio’s popular enzymes to offer reliable results that clinicians can trust. The kit’s simple yet efficient protocol has been tested and validated on commonly used thermocyclers and can accommodate a wide range of samples, making it a versatile and economical solution for all laboratories.
“Expanding our enzymes portfolio already widely used in a broad range of diagnostic assays, to launch our first CE-IVD-marked kit is an important step for us”, says Pierre Lacaze, Managing Director at TBE. “We believe that bringing a faster, simpler, yet cost-efficient solution to market will help address current bottlenecks for diagnostic labs across Europe. The reliability and convenience of this kit has already convinced clinicians in Japan, where it has been used for millions of SARS-CoV-2 tests. Today, we are pleased to serve our European customers as well.”