Performance evaluation of nucleic acid testing system for blood screening in high-altitude areas
10.13303/j.cjbt.issn.1004-549x.2023.10.018
- VernacularTitle:高海拔地区血液筛查核酸检测系统性能验证结果评价
- Author:
Liang ZANG
1
;
Lei ZHOU
1
;
Ji DUO
2
;
Hao LIN
2
;
Rui BAI
2
;
Mei YANG
2
;
Chao DAN
2
;
Yaxin FAN
1
Author Information
1. Dalian Blood Center, Dalian 116001, China
2. Nagqu Central Blood Station
- Publication Type:Journal Article
- Keywords:
high-altitude;
nucleic acid testing system (NAT system);
performance verification (PV)
- From:
Chinese Journal of Blood Transfusion
2023;36(10):935-939
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To validate the performance of a nucleic acid testing(NAT) system for blood screening in the high-altitude Nagqu region of Tibet, in order to assess the capability of NAT in high-altitude areas and further enhance blood safety. 【Methods】 Various methods were employed to evaluate the analytical sensitivity, reproducibility, ability to prevent cross-contamination, and comparison between different NAT systems. 【Results】 The NAT system in the Nagqu region of Tibet achieved a 100% detection rate for high-concentration HBV DNA and HIV-1 RNA samples, and over 90% for medium-concentration samples. PROBIT analysis revealed the lower limits of detection (LOD) for HBV DNA and HIV-1 RNA to be 8.29 IU/mL (95% CI, 5.88~20.55 IU/mL) and 40.52 IU/mL (95% CI, 30.26~85.92 IU/mL), respectively. For HCV RNA genotype 2a, the LOD was 97.14 IU/mL (95% CI, 71.00~182.67 IU/mL), all of which were lower than the declared minimum detectable concentrations in the instructions. Reproducibility analysis demonstrated a 100% level of consistency within the system. Cross-contamination performance verification showed a strong ability to resist cross-contamination. Comparative analysis of repeated testing of low-concentration HBV DNA samples and multi-system testing in plain areas revealed consistency rates of 77.78%(14/18) and 77.27%(17/22), respectively, indicating certain differences between the NAT system in Nagqu region and other systems. 【Conclusion】 The NAT system exhibited excellent performance in blood screening at high altitudes. The results of performance validation in high-altitude blood screening NAT systems were largely consistent with those in plain areas, providing a reliable basis for enhancing blood safety in high-altitude regions.
