Performance validation of a novel multiplex detection reagent for screening transfusion-associated infectious diseases
10.13303/j.cjbt.issn.1004-549x.2026.05.011
- VernacularTitle:一种用于输血相关传染病筛查的新型多重检测试剂的性能验证
- Author:
Miao LIU
1
;
Qian ZHAO
1
;
Na YAO
1
;
Jing LI
1
;
Jiahui ZHANG
1
;
Ning YE
1
;
Yuena XIE
1
Author Information
1. Tianjin Blood Center, Tianjin 300110, China
- Publication Type:Journal Article
- Keywords:
Procleix UltrioPlex E;
performance validation;
nucleic acid testing;
hepatitis E virus
- From:
Chinese Journal of Blood Transfusion
2026;39(5):650-655
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To validate the performance of the Procleix UltrioPlex E assay (Grifols, Spain) on the Procleix Panther automated nucleic acid detection platform, which employs the TMA method to simultaneously detect HIV-1/HIV-2/HCV/HBV/HEV viruses, and to evaluate its value for screening transfusion-associated infectious diseases. Methods: In accordance with the requirements of ISO15189"Application of the Guidelines for the Accreditation of Quality and Capabilities of Medical Laboratories in the Field of Molecular Diagnostics (CNAS-CL02-A009: 2018)", "Guidelines for Performance Validation of Molecular Diagnostic Testing Procedures (CNAS-GL039: 2019)", and the "Technical Operating Procedures for Blood Banks (2019 Edition)", this study validated the reagent's performance in terms of analytical sensitivity validation, performance consistency validation, interference resistance, and cross-contamination resistance. Results: Probit analysis revealed that the 95% detection limits (95% confidence interval) for HBV, HCV, HIV, and HEV were 2.0 IU/mL, 1.5 IU/mL, 18.0 IU/mL and 3.7 IU/mL, respectively, which were consistent with the minimum detection limits stated in the kit's package insert and were comparable to the Procleix Ultrio Elite kit. Both kits were used to test the performance validation serum plate simultaneously, yielding results consistent with the serum plate (Kappa=1), indicating stable performance. Detection of medium-and low-concentration lipemia and weakly positive hemolysis samples demonstrated good interference resistance. Cross-contamination performance validation showed that the kit exhibited excellent cross-contamination resistance. Conclusion: The Procleix UltrioPlex E nucleic acid detection kit enables combined detection of HIV-1, HIV-2, HCV, HBV, and HEV, allowing single-test screening for multiple viruses in donor blood. The kit's analytical performance is stable and meets basic laboratory requirements, making it suitable for screening transfusion-associated infectious diseases in blood banks.
