Voice of Customer

During the first wave of the COVID-19 outbreak, which began in late January 2020, Kyoto University Hospital (1141 beds, Director: Susumu Miyamoto) began accepting patients with COVID-19, but there was no testing system that could handle the unknown pathogen. As a result, clinical staff were having difficulty testing and treating the growing number of COVID-19 patients. "'If we can't test, we can't ensure the safety of the medical staff who treat the patients,' There was such a sense of frustration in the air," confesses Dr. Yasufumi Matsumura, Vice Director of the Department of Clinical Laboratory (Associate Professor of Clinical Laboratory Medicine at the Graduate School of Medicine, Kyoto University).

Medical staff in the intensive care unit treating a patient with COVID-19 who suffered from renal failure. (Photo courtesy of Kyoto University Hospital)

This situation was common not only to the University Hospital but to all medical institutions in Japan. With everyone in the medical community feeling a strong sense of crisis, it was Professor Shinya Yamanaka, Director Emeritus of the Center for iPS Cell Research and Application (CiRA), Kyoto University, who moved quickly to structuring PCR testing systems at hospitals. Professor Yamanaka and the Nagao Laboratory launched a joint research group "COVID-19 Fully Automated PCR Network," with Osaka City University (present Osaka Public University) and Osaka Prefecture, utilizing testing equipment donated by Sumitomo Mitsui Financial Group, and hoped to deploy PCR testing equipment at as many medical institutions as quickly as possible.

"The results of clinical tests have a direct impact on treatment, so there is no room for error. In other words, high accuracy is the lifeline of clinical testing. PCR testing, a type of genetic testing, is an area that requires a great deal of skill, and we felt that only a fully automated testing system could protect the high level of accuracy that is the lifeline of clinical testing when performed in a general hospital laboratory," said Dr. Matsumura.

However, with logistics in chaos and medical institutions fighting over PCR testing devices, how could dozens of highly precise, fully-automated PCR testing devices be secured? Dr. Matsumura recalls, "While the members of the joint research group were skeptical, it was PSS that raised its hand in response to Professor Yamanaka's call.

The laboratory department, responsible for providing technical support in the construction of the network, began performance evaluation of our fully automated PCR testing system, "geneLEAD VIII," under the leadership of Dr. Matsumura. As a result, the testing sensitivity was high and the performance was evaluated as very good, especially with regard to specimen extraction. "At first, there were no PCR reagents that could be used easily, and manual pipetting was necessary, but we thought that the accuracy of the test was sufficiently assured. The final deciding factor was the ability to supply a large volume of PCR testing equipment quickly," said Dr. Matsumura.

Thus, PSS delivered fully automated PCR testing systems (geneLEAD VIII and ELITe InGenius) to the "COVID-19 Fully Automated PCR Network." Through this network, 23 acute-care hospitals (research partner institutions) in Osaka and Kyoto that have installed these devices can now perform rapid and highly accurate testing.

"When the network began operating in the summer of 2020, there was no information on regional trends in COVID-19. So, in addition to conducting tests clinically, we decided to analyze specimens and test information gathered in our network from research partner institutions and publish trends such as the number of tests and positive rates on our website¹⁾. This is because it is the mission of our academia to utilize the data to predict the next development and consider countermeasures," said Dr. Matsumura.

The "COVID-19 Fully Automated PCR Network," which Kyoto University took the lead in foundation, analyzes information collected from research partner institutions and publishes the preliminary results on the university's website.

In April 2021, some institutions participating in the network (Kyoto, Osaka, and Shiga) also began screening tests for mutant strains. At the same time, Kyoto University has established a system that enables it to perform genome analysis, and all positive strains, including those that underwent this screening test, are subjected to whole genome analysis, which is promptly fed back to clinical sites through the website²⁾. It is also working to enhance the academic value of the data by publishing papers on 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

The Department of Clinical Laboratory Medicine at the Graduate School of Medicine, Kyoto University, where Dr. Matsumura belongs, began joint research with PSS in June 2020³⁾, and opened the "PSS Kyoto University Laboratory (PCR Testing Center)" in the Center for Advanced Medical Device Development and Clinical Research at Kyoto University Hospital in August 2022 as a new site for innovative. Dr. Miki Nagao, Director of the Department of Clinical Laboratory, Professor of Clinical Laboratory Medicine at the Graduate School of Medicine, Kyoto University, explains the aim of the center as follows:

"As one of Japan's leading medical institutions and academia, we had been thinking of establishing a system for advanced tests that are not covered by insurance but are needed clinically before the COVID-19 crisis. On the other hand, clinical evaluation is a necessary process at the stage of clinical application of products developed through joint research with PSS. Until now, this clinical evaluation has been conducted in university laboratories, but we decided to utilize this system because it would also have practical benefits by setting up a laboratory and conducting it as demonstration research. Therefore, we expect that we will be able to accept a request for special tests in the future."

"PSS Kyoto University Laboratory" opened on the second floor of the Center for Advanced Medical Equipment Development and Clinical Research, Kyoto University Hospital.

Dr. Matsumura points out that this flexible laboratory system was established because geneLEAD VIII has the advantage of being a general-purpose machine rather than a specialized machine. In other words, it is easy to draw up a strategy not only for the COVID-19 crisis, but also for the post-COVID-19 period.

PSS Kyoto University Laboratory has started its efforts by using two of our fully automated PCR testing systems (geneLEAD VIII) to perform PCR testing for a novel coronavirus (SARS-Cov-2) on contract. This is an activity that also has a strong meaning of social contribution. "Following the outbreak of the 7th wave, the testing system for COVID-19 has been further expanded, and PCR tests are now readily available in the city. But, on the other hand, since simple PCR tests are the mainstream, we wanted to provide opportunities for the public to receive high-precision PCR tests," said Dr. Matsumura.

In the future, PSS Kyoto University Laboratory plans to offer bacterial and fungal identification tests and virus identification and quantification tests as needed, as Dr. Nagao expressed his desire, targeting not only the Kansai area but also the entire country.

"PSS is already in a position to supply testing equipment and high-quality reagents. Without these, we would have to design our own equipment from scratch, repeat experiments and tests, and establish our own testing methods. Since this process requires excessive effort, having PSS take care of the development part allows us to concentrate on contracting new tests and conducting clinical evaluations. By leveraging the strengths of both companies, we hope to increase the speed at which tests needed by society can be applied clinically." said Dr. Matsumura.

3)　Evaluation research of PCR reagents for the SARS-Cov-2 test using the fully automated geneLEAD series of genetic testing systems and related systems
https://www.kyoto-u.ac.jp/ja/news/2021-07-15-1

In the fall of 2022, PSS began marketing "Saliva Soaking Stick^™" for PCR testing. In fact, the development of this product also reflected requests from the Clinical Laboratory Medicine at the Graduate School of Medicine, Kyoto University.

The "Saliva Soaking Stick^™" (photo at right), which allows specimens to be set directly into the PCR testing device, also improves work efficiency.

"When a COVID-19 outbreak occurs, laboratories have to perform a large number of PCR tests every day, so we asked them to reduce the labor required for testing as much as possible. One of the labor-saving measures was to be able to test collected specimens immediately. The Saliva Soaking Stick^™ fulfills this request. All you have to do is to put a cap on the collected specimen and set it in the PCR testing device. I am impressed by the ingenious mechanism for setting the specimen in the testing device, which I understand was developed with particular attention to detail. I think it was also significant that they succeeded in developing a solution that combines the functions of inactivating the virus and preventing viral RNA from being degraded," said Dr. Matsumura.

PSS Kyoto University Laboratory has been using Saliva Soaking Stick^™ since the end of August. According to Dr. Matsumura, no significant problems have occurred during the month or so of use. At first, some examinees said it was difficult to understand how to collect saliva, but Dr. Matsumura says that this confusion disappeared when he devised a way to collect saliva while having examinees watch a video explaining the collection procedure.

It is designed so that the examinee can follow the procedure while watching the video on the monitor.

"Unlike the one in which we collect saliva in a container, the one which absorbs saliva does not visually show the amount of saliva collected, and there is no way to evaluate whether the amount of specimen is sufficient. Therefore, there is a possibility of false negative results due to insufficient sample volume, but in the case of the Saliva Soaking Stick^™, in addition to using highly absorbent material for saliva collection, it is designed to allow testing at about 500ul, so I expect that we can avoid situations such as false negative results to a great extent," said Dr. Matsumura.

PSS Kyoto University laboratory has begun to collect data on the field evaluation of the Saliva Soaking Stick^™, and the results will be used to improve the product. The needs of the clinical field are directly communicated to our development department, which is helpful not only in the development of new products, but also in improving the usability and work efficiency of existing products.

The collaboration with Kyoto University, which began with the establishment of a PCR testing system for COVID-19, has started to expand into the next phase of post-COVID-19 efforts on the strength of our versatile PCR testing equipment and reagents.