Study on verification and evaluation for the performance of a nucleic acid test system of screening blood
10.3969/j.issn.1672-8270.2024.10.004
- VernacularTitle:血液筛查核酸检测系统的性能验证及评价研究
- Author:
Wengong DU
1
;
Xinghuan MA
;
Peng YIN
;
Peipei WANG
;
Juan LIU
Author Information
1. 廊坊市中心血站 廊坊 065000
- Keywords:
Blood screening;
Nucleic acid test;
Performance verification
- From:
China Medical Equipment
2024;21(10):19-23
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate main performance indexes and application value of a domestic blood nucleic acid test system for blood screening,so as to ensure the safety of blood screening in the system of blood bank.Methods:Twenty samples were selected from Langfang Center Blood Bank in January 2022,and 6703 blood specimens of voluntary blood donors from Langfang Blood Bank between 2022 and 2023 were simultaneously selected.According to the requirements of the"Technical Operating Procedures for Blood Stations(2019 Edition)"and the standard for medical medicine industry"Nucleic Acid Amplification Test Reagents(kits)",the performances of stability,analytical specificity,sensitivity,precision,anti-interference ability and against cross-contamination ability of nucleic acid test system were verified for the analysis of clinical application.Results:The coincidence rate of the nucleic acid test system was 100%for 20 negative plasma samples.The coincidence rates of the sensitivities of Hepatitis B virus deoxyribonucleic acid(HBV DNA),Hepatitis C virus ribonucleic acid(HCV RNA)and Human immunodeficiency virus ribonucleic acid(1+2)(HIV 1+2 RNA)were respectively 100%,and percentages of the coefficient of variation(CV%)of the precision of them were respectively 1.57%,0.75%and 1.49%.When the system conducted nucleic acid test,the hemolytic plasma with a hemoglobin concentration level of 400mg/dl and the blood specimen with triglyceride concentration levels of 3 000 mg/dl did not affect the analysis performances of the standard substances of HBV-DNA(9.0 IU/ml),HCV-RNA(30.0 IU/ml)and HIV-RNA(135.0 IU/ml)of low concentration level.There were not cross-contaminations when 10 positive samples at high concentration(1 000 IU/ml)were cross-lined with 11 negative samples to conduct test.A total of 16(0.24%)reactive specimens were checked out from 6 703 specimens by Nucleic Acid Test(NAT)Technique under mixed mode.Conclusion:Nucleic acid test system must conduct performance verification before it is put into use,so as to ensure the safety of blood screening.The currently domestic nucleic acid test system can meet the requirements of screening blood safety.The performance verification of nucleic acid test system has great value in ensuring the safety of blood screening.
