Analysis on the current situation and prospect of chemiluminescence technology in blood screening
10.13303/j.cjbt.issn.1004-549x.2025.08.019
- VernacularTitle:化学发光技术在血液筛查中的应用现状与前景分析
- Author:
Jinfeng ZENG
1
;
Haobiao WANG
1
;
Yingnan DANG
2
;
Liqin HUANG
1
Author Information
1. Shenzhen Blood Center, Shenzhen 518040, China
2. Qinghai Blood Center, Xining 810000, China
- Publication Type:Journal Article
- Keywords:
chemiluminescence immunoassay;
enzyme-linked immunosorbent assay;
blood screening;
blood-borne pathogens
- From:
Chinese Journal of Blood Transfusion
2025;38(8):1120-1126
- CountryChina
- Language:Chinese
-
Abstract:
Chemiluminescence immunoassay (CLIA), a non-radioactive immunoassay technology that has developed rapidly over the past three decades, has increasingly demonstrated its application value in blood screening due to its advantages such as high sensitivity, high specificity, rapid detection, and high degree of automation. This article systematically reviews the application status, technical characteristics, differences from traditional methods, influencing factors for promotion and application of CLIA in blood screening at home and abroad, and looks forward to its development prospects. Countries such as the United States, Germany, and Japan have widely adopted CLIA in the screening of pathogens like HBV, HCV, and HIV, predominantly using "1 CLIA test + 1 nucleic acid testing (NAT) test" model. Some regions have also expanded testing items to include anti-HBc and HTLV. In China, enzyme-linked immunosorbent assay (ELISA) combined with NAT remains the primary method. CLIA is still in the stage of detection performance comparison. However, domestic reagents have gradually been approved, and more enterprises are accelerating their layout in this field. CLIA is superior to ELISA in terms of sensitivity, detection range, and automation adaptability, which can reduce missed detection and shorten the window period. But it is limited by factors such as high cost, closed system characteristics, and domestic batch release supervision. In the future, CLIA is expected to complement existing technologies, expand the detection of emerging and re-emerging pathogens, and combine with fully automated assembly lines to improve screening quality, providing more comprehensive protection for clinical blood transfusion safety.