Optimization of HBV detection in NDR samples from blood donors
10.13303/j.cjbt.issn.1004-549x.2026.09.009
- VernacularTitle:献血者未鉴别反应性标本的HBV检测优化
- Author:
Qiang ZHANG
1
;
Yuan ZHOU
1
;
Liuming ZHANG
1
;
Weiyu YUAN
1
;
Baifeng SHAN
1
;
Zhiye LI
1
;
Lixia DOU
1
;
Aichun CHU
1
;
Xuehua HE
2
Author Information
1. Taiyuan Institute of Blood Transfusion, Taiyuan Blood Center, Taiyuan 030024, China
2. Shanxi Bethune Hospital, Taiyuan 030032, China
- Publication Type:Journal Article
- Keywords:
blood safety;
occult hepatitis B;
non-discriminated reactive;
dual detection strategy;
residual risk analysis
- From:
Chinese Journal of Blood Transfusion
2026;39(9):1223-1230
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To evaluate the effect of repeated testing combined with cross-validation using different principles of NAT systems on improving the detection rate of occult HBV infection (OBI) in HBsAg-negative/NDR samples. Methods: A total of 89 NDR samples from the Taiyuan Blood Center between August 2024 and May 2025 were enrolled. All samples were tested for HBsAg by ELISA and subjected to NAT screening using the Roche system (PCR method). For all HBsAgnegative, MPNAT+/IDNAT (NDR) samples, further crossvalidation was performed using repeat IDNAT with the Roche system and the Grifols system (TMAbased) dHBV discriminatory assay; in addition, HBV serological markers were detected, and the results were confirmed by realtime quantitative PCR and nested PCR with sequencing genotyping. The NAT yield/window period ratio model was used to estimate the residual risk of HBV transfusion for the Roche single system in actual use, and the theoretical residual risk was calculated by assuming that the Grifols system was applied to individual screening of all blood donors. Results: The detection rate of HBsAg-negative/NDR was 0.99‰ (89/90 115), consistent with the national average. Among the 89 NDR samples, 4 were confirmed as HBV DNA-positive by nested PCR (viral load 15 - 20 IU/mL), including 3 of genotype C1 and 1 of genotype B2. Serological analysis showed that the anti-HBc positivity rate in NDR samples was 24.7% (22/89); all 4 OBI samples were antiHBcpositive (18.2%) and none were antiHB-spositive. In the single-NAT system, the residual risk for first-time donors (RR_FD) was 48.98/10
person-years for the Roche system and 21.01/10
person-years for the Grifols system, both higher than the corresponding residual risk for repeat donors (RR_RD: 15.23/10
and 9.80/10
person-years, respectively), but the differences showed no statistical significance (P>0.05). Conclusion: Implementing repeated testing combined with cross-validation using different principles of NAT systems can effectively increase the detection rate of low-viral-load OBI and reduce the risk of missed detection.
