Performance evaluation of an acridinium ester-based chemiluminescence assay for heparin-binding protein and its application in the diagnosis of sepsis
10.3760/cma.j.cn112150-20250523-00469
- VernacularTitle:基于吖啶酯标记的化学发光法测定肝素结合蛋白的性能评价及其在脓毒症辅助诊断中的应用
- Author:
Yuying WANG
1
;
Sujuan YU
;
Qi CHEN
;
Bicui ZHAN
;
Kang CHEN
;
Guoqiang CHEN
;
Longbin HONG
;
Jianguo WU
Author Information
1. 杭州市中医院医学检验中心（浙江中医药大学附属杭州市中医院），杭州 310007
- Publication Type:Journal Article
- Keywords:
Heparin-binding protein;
Chemiluminescence assay;
Sepsis;
Early diagnosis
- From:
Chinese Journal of Preventive Medicine
2025;59(9):1546-1551
- CountryChina
- Language:Chinese
-
Abstract:
This study aims to comprehensively evaluate the analytical performance and clinical application value of an acridinium ester-based chemiluminescence assay for detecting heparin-binding protein (HBP), providing more accurate laboratory evidence for the early diagnosis of infections and sepsis. The analytical performance of the HBP detection kit based on acridinium ester chemiluminescence was verified in Hangzhou Hospital of Traditional Chinese Medicine in January 2024 to June 2024, including limit of blank (LoB), accuracy, precision, linear range, anti-interference ability, and clinical diagnostic concordance. The potential of this assay in early diagnosis and treatment monitoring of sepsis was assessed. HBP levels were measured in 97 patients with sepsis and 160 healthy controls, and intergroup differences were analyzed using the Mann-Whitney U test. The results showed that the LoB of the HBP detection kit based on acridinium ester chemiluminescence was 0.10 RLU, and low-concentration sample testing showed good discrimination. In the accuracy evaluation, the regression equation between the test reagent and the comparator was y=1.015 2 x-2.850 8 (R2=0.995 1). For precision, the CV in intra-assay was ≤3.51%, and the CV in inter-assay was ≤4.18%. Within the linear range of 0.42-493.46 ng/ml, the regression equation was y=0.996 9 x+3.066 0 (R2=0.999 1). In interference experiments, the relative deviation was <3%. Clinically, the median HBP concentration in the sepsis group (median: 121.1 ng/ml) was significantly higher than in the control group (median: 6.3 ng/ml, P<0.000 1), with a diagnostic sensitivity of 98.97% and specificity of 96.25%. Age stratification had no effect on HBP levels ( U=448 ,P=0.780 0). In conclusion,the acridinium ester-based chemiluminescence assay requires only about 10 minutes to complete the detection and deliver results, demonstrating acceptable sensitivity, precision, and anti-interference capability. Its wide linear range and rapid detection meet emergency testing needs. Clinical validation confirms HBP′s extremely high sensitivity and specificity for sepsis diagnosis, supporting its role as a key marker for early diagnosis, treatment monitoring, and prognosis assessment.
