CHALLENGE
CHALLENGE
Global Pandemic
Response
(COVID-19)
Fighting an unknown
infectious disease
Pandemics
- How can we help right now? Fighting a highly infectious virus with proprietary PCR testing reagents
- Healthful and abundant lives for everyone Ampdirect technology opens new pathways in medicine
How can we help right now?
Fighting a highly infectious virus with proprietary PCR testing reagents
Ampdirect technology cuts testing time significantly
In late December 2019, a new form of pneumonia, cause unknown, began to appear. Who could have predicted that this pathogen would fuel a world-threatening pandemic?
In January 2020, the pathogen was identified as a novel coronavirus, SARS-CoV-2. Before the affected nations could take effective measures, the outbreak of COVID-19 spread rapidly, leading the World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PHEIC).
Though infections were also confirmed in Japan, PCR testing systems with the needed sensitivity, as well as the personnel to perform the testing, was in short supply, causing widespread anxiety and confusion. PCR testing generally requires a multi-step purification process of the biological sample to remove impurities that can affect test accuracy. Since testing was time- and labor-intensive, the increasing number of tests required left laboratory personnel exhausted. The testing system itself represented a bottleneck in coping with the virus.
Could Shimadzu technology help? As COVID-19 continued to spread, identification of the infected became an urgent priority. As such, we resolved to begin development of a PCR testing reagent for quick detection of COVID-19.
In fact, Shimadzu had already developed Ampdirect, a proprietary technology that allows biological samples to be introduced directly into the PCR reagent. Ampdirect technology suppresses the action of PCR inhibitors in biological samples, such as proteins and polysaccharides, eliminating the DNA and RNA purification process. Using this proprietary technology, Shimadzu had already commercialized reagents to test for the norovirus and other viruses. It seemed clear that Ampdirect could demonstrate its technological superiority in PCR testing reagents for COVID-19 and contribute to solving problems on the medical frontline.
Ensuring safety for healthcare professionals
Shimadzu combined the power of its accumulated technology and teamwork, and after just a month of development work, we had a timeline to commercialize the 2019 Novel Coronavirus Detection Reagent Kit, launching it in April 2020. The early launch was made possible through the collaboration of all internal departments, but also with support from Prof. Satoshi Takahashi of Sapporo Medical University’s Department of Clinical Laboratory Medicine. As a result, we were able to proceed quickly despite the limited supply of biological samples for verification.
In Japan, the pandemic was in its first wave. Social confusion was widespread, and many restrictions were imposed. Shimadzu’s reagent had already solved the challenge of conventional PCR testing, and the company was swamped with orders. As a result, the reagent contributed greatly to significant reductions in the PCR testing burden, and made expanded testing possible.
Nevertheless, challenges remained. On the medical frontline, PCR testing required insertion of a cotton swab deep into the nasal cavity to obtain a sample from the nasopharyngeal mucosa. This form of testing was uncomfortable and, if the examinee sneezed, carried a risk of infection for the examiner. In addition, supplies of preservatives and containers for storing collected specimens were increasingly scarce on the market.
To address such problems, Prof. Takanori Teshima of Hokkaido University Hospital investigated the feasibility of a saliva-based PCR test, and confirmed that the Shimadzu reagent produced results comparable to those obtained from nasopharyngeal swabs. In May of that year, Shimadzu's PCR test kit for saliva samples was launched, accelerating the spread of testing with enhanced safety for healthcare professionals.
In the three years prior to the pandemic’s eighth (Omicron variant) wave, Shimadzu’s domestic and international shipments of reagents developed for saliva-based PCR tests have been the equivalent of roughly 12 million tests.
Healthful and abundant lives for everyone
Ampdirect technology opens new pathways in medicine
Contributing to wide-ranging pathogen detection
In May 2023, Japan changed the status of COVID-19 infection from Category 2 to Category 5 under the Infectious Diseases Control Law. While calm has returned to society, COVID-19 infections continue to occur, and another novel infectious disease can appear at any time, just as COVID-19 did.
Going forward, the next challenge for Shimadzu is to contribute further to medical care through PCR testing, which played a major role during the pandemic. We plan to leverage the capabilities of Ampdirect technology, which cuts the time required for PCR testing significantly, so that even should a new threat emerge, aggressive PCR testing can be effective in detecting new diseases and pathogens.
The PCR test is widely recognized due to the spread of COVID-19, but it has actually been in use for some time.
Utilizing Shimadzu Ampdirect technology, PCR tests could be the approach of choice for clinics and numerous other medical facilities in detecting a variety of pathogens, and would be the method of choice in more cases of infectious diseases. The challenges of medicine are also profound challenges of human knowledge. Nevertheless, our commitment to bring healthful and abundant lives to people everywhere is unwavering. Our goal is to contribute to society with reliable technologies, now and in the future.
CHALLENGE