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FUJIFILM Corporation (President: Kenji Sukeno) has commenced the development of an antigen test kit for diagnosis of SARS-CoV-2*1 infection. Fujifilm will use its proprietary silver amplification immunochromatography method*2, which is based on silver amplification technology used in the photo-developing process. The company will work to develop a fast and highly-sensitive SARS-CoV-2 antigen test kit and will work to achieve early commercialization. The development will use antibodies that can detect SARS-CoV-2 antigens, to be supplied by the Public University Corporation Yokohama City University (Kanagawa, Japan).
On January 28 this year, the Japanese government classified novel coronavirus infection (COVID-19*3, as a Designated Infectious Disease in Japan. On March 11, the WHO declared the COVID-19 outbreak to be a pandemic. The Japanese government announced a package of COVID-19 countermeasures on August 28, including one that its COVID-19 testing capacity will be increased to the daily average of 200,000 easy to use antigen tests in preparation for simultaneous outbreak of COVID-19 and seasonal influenza in colder months.
Antigen tests can be carried out quickly and produce results on the spot. Despite these advantages, antigen tests have lower sensitivity than PCR tests. Improvement of their sensitivity is required.
Since 2011, Fujifilm has marketed a rapid diagnostic testing equipment and reagents for influenza and other infectious diseases, using the proprietary “silver amplification immunochromatography method.” The system has been adopted by numerous medical institutions in Japan as a high-sensitivity antigen test capable of detecting viruses and bacteria even when viral or bacterial load is low at the onset of a disease, and producing fast results within 15 minutes.
In recent years, the company’s Rapid Tuberculosis (TB) Diagnosis Kit, a hardware-free visual testing system based on silver amplification immunochromatography, has complied with the European directive*4. Using urine as samples, the kit detects TB highly sensitively by binding a minute amount of a component specific to TB bacteria with a label and generating a large silver particle around them. Currently, the kit is undergoing clinical assessment at research institutes in various developing countries in order to obtain WHO recommendation for its distribution to those countries.
This time, Fujifilm has confirmed that even with SARS-CoV-2 antigen, a highly sensitive antigen test is feasible with the application of silver amplification immunochromatography. The company will work on developing an antigen test kit that can rapidly and sensitively examine the presence of SARS-CoV-2 antigens in specimens.
The Fujifilm Group has contributed to making SARS-CoV-2 testing faster by supplying PCR test reagents and the reagents for use with the fully-automated immunoassay system “μTASWako g1,”*5 capable of performing simple and rapid PCR testing in full automation. (These SARS-CoV-2 reagents are currently available in Japan only.) By providing a wide range of products and services that meet the needs of medical frontline, the Fujifilm Group will continue to help improve the efficiency of SARS-CoV-2 testing and improve the quality of medical care.
*1 Official name of the new coronavirus
*2 Immunochromatography is a testing method in which a specimen (e.g. nasopharyngeal swab) is processed in a reagent. If the specimen contains a test substance (e.g. virus), it binds with a labeled antibody in the reagent to generate an immune complex. When the complex is captured by an antibody which is coated beforehand along a detection line, the line manifests color, indicating a positive result (containing antigens). The method produces results easily and rapidly, and is therefore used frequently for detecting an infectious disease that requires quick treatment.
*3 Official name of the new coronavirus infection
*4 European Union (EU) In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)
*5 Medical device notification number 27B3X00024000016, manufactured and marketed by FUJIFILM Wako Pure Chemical Corporation
FUJIFILM Holdings Corporation
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