Virus Detection
2019 Novel Coronavirus Detection Kit

Speed and accuracy are crucial for the detection and containment of the SARS-CoV-2 novel coronavirus. Shimadzu has developed the “2019 Novel Coronavirus Detection Kit” based on Shimadzu’s unique gene amplification reagent, Ampdirect® technology for PCR analysis, and the pathogen detection manual from the Japanese National Institute for Infectious Diseases.

As compared to regular kits, this detection kit eliminates the need for RNA extraction and purification and halves the overall time required for PCR detection.

Shimadzu will continue to contribute to measures against infectious diseases by developing reagents that detect pathogens quickly and efficiently.

(*) The kit (Research Use Only) is only available in Japan.
On September 8, 2020, we obtained approval from the Japanese Ministry of Health, Labor and Welfare for the marketing of "Ampdirect™ 2019-nCoV Detection Kit" for in vitro diagnostics in Japan.

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Clinical & Biotechnology Business Unit, Life Science Business Department, Analytical & Measuring Instruments Division Masamitsu Shikata

Clinical & Biotechnology Business Unit, Life Science Business Department, Analytical & Measuring Instruments Division
Masamitsu Shikata

* This interview was conducted in June 2020.

Contributing to PCR Analysis

We have been working on the development of gene-detecting reagents for use in the PCR analysis of infectious diseases. With the spread of COVID-19, the demand for PCR testing has increased, and it is becoming difficult for clinical laboratories to obtain existing reagent kits in Japan. We were eager to assist clinical researchers at the forefront of the struggle against COVID-19 by developing a reagent kit that can detect the new coronavirus. The kit would be based on a proven technology, unique to Shimadzu, which shortens the time required for PCR analysis.

PCR analysis requires amplification of viral genes. Based on our experience in developing reagent kits for detecting pathogens such as norovirus, I initially thought that our technology could be applied to the new coronavirus without much difficulty. However, as development progressed, we found the amplification of the new coronavirus was not as easy as expected. To overcome this obstacle, our team intensified its effort into devising reagent compositions to detect the virus with high sensitivity.

The newly-developed novel coronavirus detection kit (*) eliminates the steps of RNA extraction and purification, significantly reducing the amount of work required to prepare samples. Moreover, it halves the overall time required for PCR detection from over 2 hours to approximately 1 hour. It can detect viruses not only using samples taken from the back of the nose or throat, but also those taken from saliva.

Customers using this product have told us that their workload has been reduced and that they are satisfied with the kit’s performance, as the sensitivity is equivalent to or higher than that of conventional methods.

(*) The kit (Research Use Only) is only available in Japan.
This interview was recorded in June 2020.
On September 8, 2020, we obtained approval from the Japanese Ministry of Health, Labor and Welfare for the marketing of "Ampdirect™ 2019-nCoV Detection Kit" for in vitro diagnostics in Japan.