FUJIFILM Europe GmbH received the CE certificate and thus able to apply the CE mark to and launch an antigen test kit for diagnosis of SARS-CoV-2* infection. Fujifilm is using its proprietary silver amplification immunochromatography method**, which is based on silver amplification technology used in the photo-developing process.
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 even when viral load is low at the onset of a disease.
Fujifilm can now confirm that even with SARS-CoV-2 antigen, a highly sensitive antigen test is feasible with the application of silver amplification immunochromatography. The company developed an antigen test kit that can rapidly and sensitively examine the presence of SARS-CoV-2 antigens in specimens, detecting the virus at an early stage and in view of a relatively low viral load. Fast results are produced within 10-13 minutes.
During the pandemic Fujifilm supported the global healthcare community in the complex management of the emergency.” says Mr. Masaharu Fukumoto, Senior Vice President FUJIFILM Europe GmbH Medical Systems Division. “It did so through its diagnostic and IT/AI solutions so that COVID-19 patients could be treated with the utmost care and precision. Today we can provide further support for the early detection of COVID-19, through a rapid antigen test that can provide a highly sensitive result for early detection. We used our proprietary silver amplification immunochromatographic method, that amplifies signal particles more than 100 times and increases the sensitivity, and has the potential to enhance detection in more asymptomatic patients carrying the COVID-19 virus an at an early stage.
The Fujifilm rapid antigen test uses nasopharyngeal swab samples and can be performed within the community as well as clinical settings, which enables a faster result than the current laboratory tests.#
The Fujifilm Group also has contributed to improving SARS-CoV-2 testing by supplying PCR test reagents and the reagents for use with the fully-automated immunoassay system “μTASWako g1,”*** capable of performing simple and quick PCR testing in full automation (μTASWako g1 and 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.
*Official name of the new coronavirus
**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 fast treatment.
*** Medical device notification number 27B3X00024000016, manufactured and marketed by FUJIFILM Wako Pure Chemical Corporation