External quality assessment of NAT blood screening: an inter laboratory analysis
10.13303/j.cjbt.issn.1004-549x.2021.11.015
- VernacularTitle:血液筛查核酸检测室间质评结果分析
- Author:
Zhichun HE
1
;
Xiaofei WU
1
;
Yao JIA
1
;
Zhong XU
1
;
Yuwen HUANG
1
;
Qin MO
1
;
Xun WANG
1
Author Information
1. Shanghai Blood Center, Shanghai 200051, China
- Publication Type:Journal Article
- Keywords:
blood screening;
NAT;
external quality assessment;
HBV;
HCV;
HIV
- From:
Chinese Journal of Blood Transfusion
2021;34(11):1225-1227
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To summarize and analyze the results of local laboratories participating in China International Transfusion Infection Control (CITIC) Nucleic Acid Testing (NAT) External Quality Assessment (EQA). 【Methods】 The basic situation, test reagents, and abnormal results of 9 domestic laboratories participating in NAT EQA from 2018 to 2020 were collected and analyzed. 【Results】 Among 7 545 testing results, submitted by 48 laboratories using 8 test reagents throughout 9 occasions of CITIC, 64% (4 830/7 545) used imported and 36% (2 715/7 545), domestic reagents. Thirty-one abnormal results were reported, with false negative in 61.29% (19/31), false positive 6.45% (2/31), and others 32.25% (10/31). False negative results only appeared in samples with low viral load of HBV A genotype(40 IU/mL), HCV 1b subtype(40 IU/mL) and HIV B genotype(250IU/mL), relatively concentrated in a few laboratories. The frequency of abnormal results was 0.08 per laboratory per CITIC test. 【Conclusion】 The detection capacity of domestic blood stations has been significantly improved along with the routine NAT practice and regular NAT EQA participation over 5~10 years, but laboratory management still needs to be further strengthened to ensure the reagent testing performance and blood safety.
