Sysmex Corporation (HQ: Kobe, Japan; president: Hisashi Ietsugu) announced today that it has achieved the world’s highest level of detection sensitivity for hepatitis B testing parameters which exceeds the level recommended by the Food and Drug Administration of the United States. This has been accomplished by making improvements on the measurement technology used in immunochemistry tests, which play a central role in supporting early detection and treatment of infectious diseases and cancer.
We are currently working on the development of the world’s most sensitive platform for immunochemistry tests by making use of this improved measurement technology. At the same time, we are pouring more resources into product development in order to promptly expand our reagent lines for a variety of immunochemistry tests, including cancer markers and hormones.
Immunochemistry tests use blood and other specimens to investigate the existence of viral infections, cancer cells, and hormonal abnormalities. They are conducted extensively during medical examinations at companies, schools, clinics, and hospitals, as well as during follow-ups.
Accounting for about a quarter of the diagnosis market, or approximately 700 billion yen, the immunochemistry test market has recorded double-digit growth in recent years. Specifically, the number of tests conducted on parameters for infectious diseases, some of the most frequently-used parameters in immunochemistry tests, is growing more quickly in Asian countries than in any other region.
Because immunochemistry tests are essential in supporting the early detection and treatment of infectious and other types of diseases, instrument manufacturers are trying to improve testing accuracy by increasing the sensitivity of their instruments. Meanwhile, the FDA recommends a level higher than that of currently available highly-sensitive instruments (0.2ng/mL) be used for parameters for hepatitis B (HBs antigen measurement tests).
In general, immunochemistry tests make use of antigen-antibody reactions, and require instruments and dedicated reagents. A change in measuring technology requires the development (readjustment) of new instruments and all reagents used.
Recent years have seen the commercial use of tests that achieve higher sensitivity through gene-related technology. Due to high testing costs and long measuring time, however, these tests are being performed only for limited applications in Japan.
Sysmex has successfully improved chemiluminescent enzyme immunoassay technology, one of the measuring technologies used in immunochemistry tests, to achieve the world’s highest-level detection sensitivity. Through integration of the latest chemiluminescent substrate and our proprietary immunoassay technology, we have realized a sensitivity of 0.03IU/mL (equivalent to 0.2ng/mL) for HBs antigen detection, thus achieving the high level of sensitivity recommended by the FDA.
Going forward, we will tap into our expanded product portfolio which now features the PAMIA series, the world’s only instrument capable of whole-blood testing, and ELSIA fully automated enzyme immunochemistry analyzers, as well as this new highly-sensitive instrument for chemiluminescent enzyme immunoassay, thus further expanding our product range as a leading comprehensive supplier and strengthening our position as a solution provider in Asia.
*Estimated by Sysmex
|
