PSS User Voice: Kyoto University Hospital introduces PCR testing equipment from Precision System Science

PSS
User Voice: Kyoto University Hospital introduces PCR testing equipment from Precision System Science
Supporting research for infection control, from building a PCR network to opening a laboratory

While Japan was hit by the first wave of new coronavirus infections, in the Kinki region, Kyoto University played a central role in introducing high-precision PCR testing equipment to multiple acute care hospitals and establishing a testing system at hospitals. , the “COVID-19 Fully Automated PCR Network” was launched to utilize the collected sample information for clinical and research purposes. GeneLead Eight and Elite Ingenius from Precision System Science Co., Ltd. (hereinafter referred to as “our company”, headquartered in Matsudo City, Chiba Prefecture) have been adopted for this project. Furthermore, joint research with Kyoto University started in 2020, and the “PSS Kyoto University Lab” was opened in August 2010. We interviewed Dr. Miki Nagao, Director of the Laboratory Department, Kyoto University Hospital, and Dr. Yasushi Matsumura, Deputy Director, about the possibility of collaboration between academia and industry through these two initiatives.
(This interview was conducted in September 2022.)
Kyoto City, Kyoto Prefecture Kyoto University Hospital
Inspection Department Manager Miki Nagao
Yasushi Matsumura Deputy General Manager
Delivered products: Gene Lead Eight, etc.
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Miki Nagao Director
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Yasushi Matsumura Deputy General Manager
Building a PCR network centered on Kyoto University in the midst of the first wave of the new coronavirus
In the first wave that started in late January 2020, the Kyoto University Hospital (Director Miyamoto Susumu, 1141 beds) started accepting patients with new coronavirus infections, but there are existing facilities that can handle unknown pathogens. In the absence of a testing system, the number of patients with the new coronavirus infection was increasing day by day, and clinical sites were struggling with testing and treatment. “If we can’t test, we can’t ensure the safety of the medical staff who provide treatment. There were voices filled with such frustration.” Associate Professor Yasushi Matsumura confides.
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Medical staff in the intensive care unit treating a COVID-19 patient with renal failure (provided by Kyoto University Hospital)
This situation was not limited to the university hospital, but was common to all medical institutions in Japan. While everyone in the medical field had a strong sense of crisis, Professor Shinya Yamanaka, Emeritus Director of the Kyoto University iPS Cell Research Institute, was the first to move toward building a PCR testing system. Professor Yamanaka and Nagao Laboratory launched a joint research group, “COVID-19 Fully Automated PCR Network” with Osaka City University (currently Osaka Public University) and Osaka Prefecture, utilizing testing equipment donated by Sumitomo Mitsui Financial Group. We wanted to deploy PCR testing equipment in as many medical institutions as possible.
“Since clinical test results directly affect treatment, no mistakes are allowed.In other words, high accuracy is the lifeblood of clinical testing. In the field of clinical testing, I thought that the high accuracy that is the lifeline of clinical testing could not be maintained without a fully automated testing device,” said Dr. Matsumura.
However, in a situation where logistics is chaotic and medical institutions are competing for PCR testing equipment, is it possible to secure dozens of high-precision, fully automated PCR testing equipment? “The members of the joint research group were skeptical, but it was your company (PSS) that raised their hands when Professor Yamanaka called for it,” recalls Professor Matsumura.
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The Testing Department, which was in charge of technical support in building this network, started performance evaluation of our fully automatic PCR testing device “Genelead Eight” led by Dr. Matsumura. As a result, the sensitivity of the test was high, and it was evaluated that the performance was particularly good in terms of sample extraction. “At first, there were no easy-to-use PCR reagents, and manual dispensing work was required, but I thought that the accuracy of the test was sufficiently guaranteed. was able to quickly supply the PCR test equipment for
Analyzing test information in the Kinki region and publishing preliminary figures for the number of tests and the positive rate In this way, we have delivered fully automated PCR testing equipment (Genelead Eight, Elite Ingenious) to the “COVID-19 Fully Automated PCR Network”. Rapid and highly accurate testing has become possible at 23 acute care hospitals (research partner institutions) in Osaka and Kyoto prefectures that have introduced these devices through this network.
“In the summer of 2020, when this network started operating, there was no information on regional trends regarding the novel coronavirus infection. We analyzed the specimens and test information collected, and decided to publish trends in the number of tests and the positive rate on our website*1). It is our mission as academia to go there.” (Prof. Matsumura)
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The “COVID-19 Fully Automated PCR Network”, which was built mainly by Kyoto University, analyzes information collected from research cooperating institutions and publishes preliminary figures on the university’s website.
In April 2009, some facilities (Kyoto, Osaka, Shiga prefectures) participating in the network started screening tests for mutant strains. At the same time, Kyoto University has put in place a system that allows genome analysis to be performed, and positive strains, including strains that have undergone this screening test, are subjected to whole-genome analysis, and are promptly fed back to clinical sites through the website *2). We are also working to increase the academic value of data by publishing these trends and analysis results.
*1 “COVID-19 Fully Automated PCR Network”
https://clm.med.kyoto-u.ac.jp/wordpress/?page_id=439
*2 “SARS-Cov-2 Genome Analysis”
https://clm.med.kyoto-u.ac.jp/wordpress/?page_id=555
Opened “PSS Kyoto University Laboratory (PCR Testing Center)” as a place for empirical research
On the other hand, the Department of Clinical Pathology, Graduate School of Medicine, Kyoto University, to which Dr. Matsumura belongs, started joint research*3 with our company in June 2008. “PSS Kyoto University Laboratory (PCR Testing Center)” was established in the University Hospital’s Advanced Medical Device Development and Clinical Research Center. Dr. Miki Nagao, Director of the Laboratory Department of the University Hospital and Professor of Clinical Pathology, Graduate School of Medicine, Kyoto University, explains the aim as follows.
“As one of Japan’s leading medical institutions and academia, we have been wanting to build a contract system for special tests that are not covered by health insurance but have clinical needs. Clinical evaluation is an essential process in the clinical application stage of products developed through joint research.
However, by setting up a laboratory and conducting empirical research, we can also benefit from it, so we decided to use this system. We expect that we will be able to accept orders for special inspections in the future.” (Professor Nagao)
Professor Matsumura points out that the reason why we were able to build such a flexible laboratory system is because Genelead Eight has the advantage of being a general-purpose machine rather than a dedicated machine. In other words, it is easy to draw a strategy that looks ahead not only to the corona disaster but also to the
post-corona.
At the PSS Kyoto University Lab, we are using two of our company’s fully automatic PCR testing devices (Genelead Eight), and have started working on contracted PCR testing for the new coronavirus
(SARS-Cov-2). This is an activity that has a strong meaning of contributing to society. “In response to the outbreak of the 7th wave, the inspection system for new coronavirus infections has been further promoted, and it has become possible to easily receive PCR tests in the city. PCR tests are the mainstream, so I wanted to provide the general public with the opportunity to undergo highly accurate PCR tests.” (Prof. Matsumura)
In the future, as Professor Nagao has expressed his desire, we plan to conduct bacteria and fungus identification tests and virus
identification and quantitative tests as needed. I’m here.
“PSS already has a system in place to supply not only testing equipment but also high-quality reagents. Without such equipment, we would have had to design everything from scratch, repeat experiments and tests, and establish testing methods. No. This process requires an excessive amount of effort, so having PSS handle the development part allows us to concentrate on conducting clinical evaluations for new tests. We would like to speed up the clinical application of the tests that are needed.” (Dr. Matsumura)
*3 Evaluation research of SARS-Cov-2 test PCR reagents using the geneLEAD series of fully automatic genetic testing devices and related systems
https://www.kyoto-u.ac.jp/ja/news/2021-07-15-1
Direct delivery of clinical needs and involvement in the improvement of PCR testing equipment
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The “Saliva Collection Soak Stick Kit”, which allows you to set the collected sample directly in the PCR test device, also contributes to the improvement of work efficiency.
“If the new coronavirus infection spreads, the laboratory will have to perform a large number of PCR tests every day, so I asked them to reduce the labor required for the test as much as possible. The saliva collection soak stick kit is a product that satisfies this need, and all you have to do is cover the collected sample with a cap and set it in the PCR test device. I am impressed that the mechanism for setting the specimen in the testing device is very ingenious.It is a solution that has both the processing to inactivate the virus and the function to prevent the RNA of the virus from being decomposed. I think the success of the development was also a big factor.” (Professor Matsumura)
At the PSS Kyoto University Lab, we have been using saliva collection soak stick kits in advance since the end of August. According to Dr. Matsumura, there have been no major problems during the one-month period of use. At first, some test takers complained that it was difficult to understand how to collect saliva. It is said that [Image 8d87187-16-a5e137d3bcc7fbbb11eb-8.jpg&s3=87187-16-6c7a679293e16f3fcf915cf67b033ce0-360x540.jpg
The test is designed so that test takers can collect saliva according to the procedure while watching a moving image on the monitor. “Unlike the type that collects saliva in a container, the type that absorbs saliva does not have a visual sense of the amount of sample collected, and there is no means to evaluate whether the amount of sample is sufficient. There is a possibility, but in the case of the saliva collection soak stick kit, in addition to using a material with high water absorption for collecting saliva, it is designed to be able to test with about 500ul, so there is no false negative. I expect that such a situation can be largely avoided.” (Professor Matsumura) At the PSS Kyoto University Lab, we have started collecting data for the field evaluation of the saliva collection soak stick kit, and we plan to use the results of this accumulation and analysis to improve the product. The direct delivery of clinical needs to our development department helps us not only develop new products, but also improve the usability and work efficiency of existing products.
The collaboration with Kyoto University, which began with the establishment of a PCR testing system for the new coronavirus infectious disease, will develop into the next initiative for the post-corona, taking advantage of our versatile PCR testing equipment and reagents. starting.

Details about this release:
https://prtimes.jp/main/html/rd/p/000000016.000087187.html


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