Study on performance verification of enzyme-linked immunosorbent assay in blood screening laboratory
10.13303/j.cjbt.issn.1004-549x.2021.09.026
- VernacularTitle:血液筛查实验室酶联免疫法性能验证的探讨
- Author:
Linfeng WU
1
;
Dandan DU
1
;
Ran LI
1
;
Yu ZHAO
1
;
Heng LIU
1
;
Xiaoxuan XU
1
;
Jinfeng ZENG
1
Author Information
1. Shenzhen Blood Center, Shenzhen 518035, China
- Publication Type:Journal Article
- Keywords:
performance verification;
enzyme-linked immunosorbent assay;
blood screening;
detection system
- From:
Chinese Journal of Blood Transfusion
2021;34(9):1036-1039
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To validate the performance of enzyme-linked immunosorbent assay (ELISA) for the detection of antigens and antibodies for blood-borne diseases, so as to meet the requirements of blood screening laboratories. 【Methods】 The reproducibility, precision, sensitivity, specificity, conformance and detection limit of ELISA reagents under different detection procedures were verified according to relevant standards and reagent instructions. 【Results】 The performance verification results of the test procedures were in line with the relevant standards and laboratory requirements. 【Conclusion】 The performance of ELISA method can meet the relevant standards and requirements, as well as the application requirements of the laboratory. Through the analysis and comparison of the performance verification data, the blood screening laboratory can better understand the performance indicators of the detection system, continuously improve the performance of the detection system, and ensure the safety of clinical blood use.
