Joint research by ROHTO Pharmaceutical and Osaka City University
We evaluated the performance of rapid test kits for coronavirus (SARS-CoV-2) antigens using laboratory samples.
Jun 30, 2021
ROHTO Pharmaceutical Co., Ltd. (Head Office: Osaka City, President: Masashi Sugimoto) conducted a performance assessment of a rapid test kit for corononavirus (SARS-CoV-2) antigens using domestic clinical samples, specifically nasopharyngeal samples, in collaboration with the Osaka City University Graduate School of Medicine (Professor Kakeya at Department of Infection Control Science, Associate Professor Yasutoshi Kido at Department of Parasitology and Senior Lecturer Yu Nakagama).
The product was launched on June 16, 2021. Distribution, sales, and promotional activities within the country are entrusted to companies with whom we have sales alliance agreements.
We will continue to actively conduct research and development through industry-academia collaboration and will continue to contribute to the health of people by addressing the requirements of medical institutions and patients.
Background: Rapid antigen testing by immunochromatography
Rapid immunochromatographic antigen test is a simple and rapid point-of-care medicine that detects and guides diagnosis of viral antigens in symptomatic individuals and is useful for screening symptomatic individuals in outpatient settings.
In particular, in regions and countries where large-scale testing equipment such as PCR is not available, the use of such equipment is considered to be even higher, even though the convergence of coronavirus (SARS-CoV-2) infections is not visible.
In addition, on May 28, 2021, Coronavirus Response Headquarters revised and announced the basic response policy,”The government encourages the implementation of testing for individuals with mild symptoms using antigen rapid test kits, among other measures, in workplaces as well, with the perspective of preventing the widespread occurrence of clusters and alleviating the strain on the healthcare system. In the event of a positive case being identified, efforts are made to quickly and flexibly conduct administrative testing, including PCR tests, while reducing the administrative burden on public health offices and ensuring a broad scope of contact tracking.”
We anticipate a continued rise in the demand for high-quality rapid antigen tests.
Study conclusion
A performance evaluation of the coronavirus (SARS-Cov-2) antigen rapid test kit using domestic clinical samples (nasophatyngeal swab) was performed. This evaluation verified that the test kit exhibited high sensitivity (positive percent agreement) for samples with more than 105 copies per test and achieved a specificity (negative percent agreement) of 100%.
Based on this results, we conclude that the test kit holds clinical utility for reliably confirming positive or negative diagnosis in patients exhibiting specific symptoms, in accordance to the established test guidelines.
Future Outlook for ROHTO Pharmaceutical and Osaka City University
We will continue our joint research with Osaka City University.
Based on the aforementioned background, our commitment is to enhance global public health. This will be achieved by addressing the requirements of medical and research institutions, as well as patients worldwide, through the expansion of coronavirus antigen rapid test kits, including those suitable for self-collected specimens and international deployment.
In addition, the Osaka City University Graduate School of Medicine and Parasitology, responsible for the performance evaluation, has been conducting research activities on infectious diseases in regions such as Africa, Central and South America for many years. This collaborative research will be further developed at Osaka City University’s overseas research facility in the Democratic Republic of the Congo.※
※）https://www.osaka-cu.ac.jp/ja/news/2020/200420