Data analysis of resolution discrepancies in minipool nucleic acid testing: A 2024 national study of Chinese blood stations
10.13303/j.cjbt.issn.1004-549x.2026.04.002
- VernacularTitle:2024年度全国血站实验室核酸检测混样拆分错项数据分析
- Author:
Ying YAN
1
;
Qing HE
2
;
Wei ZHENG
3
;
Jie MA
4
;
Le CHANG
1
;
Huimin JI
1
;
Huizhen SUN
1
;
Lunan WANG
5
Author Information
1. National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
2. Yunnan Kunming Blood Center, Kunming 650000, China
3. Harbin Blood Center (Heilongjiang Provincial Blood Center), Harbin 150056, China
4. National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China; Centre of Biotherapy, Beijing Hospital, National Centre for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
5. National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China; Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100730, China
- Publication Type:Journal Article
- Keywords:
blood donors;
blood Screening;
nucleic acid testing;
pool resolution
- From:
Chinese Journal of Blood Transfusion
2026;39(4):423-429
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To investigate the incidence, characteristics, and influencing factors of resolution discrepancies within the minipool (MP) testing model across Chinese blood station laboratories in 2024. Methods: A nationwide, multicenter, cross-sectional study was conducted, including 334 blood station laboratories that reported nucleic acid reactive data among enzyme immunoassay non-reactive samples. Of these, 296 laboratories adopted the pool resolution model, with a total of 12 536 273 samples tested. Systematic analysis was performed on resolution data, focusing on the MP-NAT reactivity rate, the pool resolution concordance rate, and the resolution discrepancy rate. Subgroup analyses were conducted based on reagent types, viral targets, and Ct values. Potential causes were further explored through laboratory surveys and re-examination of raw amplification curves. Results: In 2024, the national average MP-NAT reactivity rate was 0.15%. The overall pool resolution concordance rate was 57.86%, which showed a gradual decline as Ct values increased across all reagents. The national average resolution discrepancy rate was 0.081‱(102/12 536 273), with 17.91%(53/296) of laboratories reporting at least one discrepancy. Nine reagent types were associated with these events, exhibiting reagent-specific patterns. For Reagent A2, the predominant discrepancy was HBV reactive pools resolving as HIV (36.36%); for Reagent D1, HBV pools frequently resolved as HCV (38.89%); and for Reagent E, the most common pattern was HIV pools resolving as HBV (48.00%). These resolution discrepancies were strongly associated with high Ct values: the median pool Ct for HBV exceeded 38, while those for HCV and HIV both exceeded 40. Investigations across 16 laboratories revealed that most discrepant samples exhibited “tailing” amplification curves, with some cases linked to cross-contamination or reagent batch-specific issues. Conclusion: While the incidence of resolution discrepancies in the MP-NAT model remains low in China, variations exist across different reagents and laboratories. These discrepancies are closely associated with low viral load, reagent performance, and laboratory operational practices.
