Performance verification experiment for enzyme-linked immunosorbent assay in blood screening laboratory
10.13303/j.cjbt.issn.1004-549x.2023.11.019
- VernacularTitle:血站血液检测实验室ELISA项目性能验证试验建立与探讨
- Author:
Humin LIU
1
;
Xue CHEN
1
;
Wenjun LI
1
;
Yinglan LUO
1
;
Jing MEI
1
Author Information
1. Chengdu Blood Center, Chengdu 610020, China
- Publication Type:Journal Article
- Keywords:
performance verification;
detection system;
ELISA
- From:
Chinese Journal of Blood Transfusion
2023;36(11):1049-1054
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To verificate the performance of enzyme-linked immunosorbent assay (ELISA) in blood screening laboratory. 【Methods】 The repeatability, precision, sensitivity, specificity, compliance, detection limit and anti-interference of ELISA items in the laboratory detection system were verified. 【Results】 The repeatability was 100%.The intra batch imprecision of each system was less than 10%, and the inter batch imprecision was less than 15%. The sensitivity, specificity and compliance were 100%, with the minimum detection limits of the two reagents at 0.75 NCU/mL and 0.25 NCU/mL respectively, The anti-interference met the requirements of the reagent manual. 【Conclusion】 The analysis of the performance verification data of ELISA test items will help continuously improve the performance of detection system and ensure the safety of clinical blood use.
