10 Authoritative Medical Institutions Evaluated GR Tests

In order to promote the improvement of the technology, optimize the product structure and ensure the quality of medical laboratory testing, Shanghai Clinical Laboratory Center invited 10 hospitals from different regions, including Peking Union Medical College Hospital, Southern Hospital of Southern Medical University, Ruijin Hospital of Shanghai Jiaotong University, General Hospital of the Chinese people's Liberation Army, First Affiliated Hospital of Harbin Medical University, Sichuan Provincial People's Hospital, etc., which have considerable academic value in China to participate in the multi institute performance evaluation and validation seminar. The success of the seminar aims to provide an operational basis for the horizontal evaluation and comparison of IVD reagent product, and fill in the gap of current domestic test reagent quality evaluation standards. Under the harsh conditions of different regions, latitudes, equipment, environments and operators, with the same sample`s been used to start the verification and detection at the same time. The strictness of this experiment is the first time in China. The results of each laboratory's final report have a stable linear distribution, and its accuracy has surpassed that of similar imported products. It has laid a solid foundation for the establishment of IVD industry in vitro diagnostic reagent product quality evaluation system.

As a means of quality audit, general reagents will pass performance verification to verify the matching of reagents and test system before entering the center for formal use. With imported reagents still dominating the market and a large area of land firmly under control, domestic brands continue to pursue them. The reagent quality evaluation of glutathione reductase test project was applied by Jiangxi Lecheng Biomedical Co., Ltd. after years of continuous research and development, the company launched the glutathione reductase (GR) test kit (ultraviolet enzyme method). Through the 9 items of evaluation including analysis of detection limit, linear range, reportable range, accuracy (recovery experiment), accuracy (methodological comparison), precision, interference, etc., it has successfully reached the expectation, which provides valuable evaluation criteria for more domestic IVD manufacturers to carry out performance verification through product quality evaluation experiments, and also provides reference for unified standards, methods and clinical evaluation.

Glutathione reductase (GSH) is an enzyme that catalyzes the reaction of oxidized glutathione (gs-sg) to reduced glutathione (GSH) by NAD (PH). It widely exists in human red blood cells, monocyte macrophages, liver, kidney, heart and other tissue cells. Among them, it has the highest content and activity in human liver. It is the main flavin enzyme to maintain the content of reduced glutathione (GSH) in cells, and plays a very important role in protecting the integrity of liver cell membrane. In the early stage of acute hepatitis, the sensitivity of glutathione reductase is the highest, and reaches the peak earlier than transaminase, which can be used for early detection of liver damage. At the same time, unlike ALT and AST, which can only be detected when the hepatocyte membrane and mitochondria are ruptured, GR can fill the gap between the early stage of self-repairing and the process of rupture, which will be more conducive to the diagnosis and treatment of early hepatitis.