From：Major Inspection
Reprinted from: Major Inspection wechat Official Account
The group standard T/CSBME 091-2025 "Oxidized Low-density Lipoprotein Detection Kit (Immunoturbidimetric Method)" has been officially released
On June 18, 2025, the "Oxidized Low-density Lipoprotein Detection Kit (Immunoturbidimetric Method)" (Standard Number:) was jointly drafted by 28 units including Xi 'an Jinci Nano-Biotechnology Co., LTD., Beijing Tiantan Hospital Affiliated to Capital Medical University, and People's Hospital Affiliated to Chongqing University under the jurisdiction of the Chinese Society of Biomedical Engineering. The group standard T/CSBME 091-2025 has been officially released and will come into effect on August 1, 2025.
Oxidized low-density lipoprotein (ox-LDL) is the product of oxidative modification of low-density lipoprotein in the body. It can be recognized by scavenger receptors and induce macrophages to form foam cells, which is a key link in the occurrence and development of atherosclerosis. However, previously, there was a lack of a unified ox-LDL detection standard in China, which made it difficult to make horizontal comparisons of the test results and affected the early diagnosis of cardiovascular diseases.
The standard system released this time standardizes the technical requirements, inspection methods, identification labels, transportation and storage of immunoturbidimetric detection kits and their accompanying calibrators and quality control products. For the first time, it clearly stipulates the key performance indicators of reagents such as precision, accuracy, linear range, analytical sensitivity and blank limit, ensuring the accuracy and reliability of the test results. Provide standardized tools for the early screening of atherosclerotic cardiovascular disease (ASCVD).
This standard was jointly formulated by 30 top domestic medical institutions, research institutes and enterprises, forming an integrated collaborative model of "industry-university-research-medical-inspection". Professor Luo Yang, the main drafter of the standard, vice president of Chongqing University Medical College, director of the Department of Medical Laboratory of Chongqing University Affiliated People's Hospital, and deputy director of Chongqing Clinical Laboratory Center, said, "The release of this standard marks a crucial step forward for China in the field of early detection of atherosclerosis. It will significantly enhance the early screening capabilities of cardiovascular diseases in primary medical institutions and facilitate precise prevention and control."
In the future, with the promotion and application of this standard, the cardiovascular disease risk early warning and early intervention system in our country will be further improved.
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