Analytical performance and standardization of four HCV RNA assays in China: an evaluation of sensitivity, precision, and genotype inclusivity
IntroductionAccurate, specific, and sensitive detection and quantification of hepatitis C virus (HCV) RNA are critical for diagnosing and managing HCV infections. This study evaluated and compared the performance of four commercially available HCV RNA quantification reagents using standardized serum...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-06-01
|
| Series: | Frontiers in Microbiology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmicb.2025.1594410/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849699069387079680 |
|---|---|
| author | Hao Yan Hao Yan Bing Xu Qinyi Zhang Qinyi Zhang Lijun Zhang Zhihan Fang Huijun Zhang Junhang Pan Wenge Xing |
| author_facet | Hao Yan Hao Yan Bing Xu Qinyi Zhang Qinyi Zhang Lijun Zhang Zhihan Fang Huijun Zhang Junhang Pan Wenge Xing |
| author_sort | Hao Yan |
| collection | DOAJ |
| description | IntroductionAccurate, specific, and sensitive detection and quantification of hepatitis C virus (HCV) RNA are critical for diagnosing and managing HCV infections. This study evaluated and compared the performance of four commercially available HCV RNA quantification reagents using standardized serum panels, providing evidence-based insights for clinical applications.MethodsPerformance metrics, including analytical sensitivity, specificity, limit of detection (LOD), precision, genotype inclusivity (GT 1–6), and linearity, were assessed using seven distinct serum panels: basic, analytical specificity, seroconversion, analytical sensitivity, precision, genotype qualification, and linearity panels.ResultsAll reagents demonstrated 100% analytical sensitivity and specificity (95% CI: 79.95–100), with no cross-reactivity to common interfering substances or viruses. LOD values for reagents A, B, C, and D were 25, 50, 50, and 50 IU/ml, respectively. Intra- and inter-assay coefficients of variation (CVs) for HCV genotypes 1–6 ranged from 1.48 to 4.37% and 1.74 to 4.84%, respectively. Strong linear correlations (R2 > 0.95) were observed between measured and expected HCV RNA levels across all reagents.ConclusionThese reagents exhibit high sensitivity, specificity, precision, and accuracy for HCV genotypes 1–6, with a wide linear range, making them suitable for clinical diagnosis and monitoring of HCV infections. |
| format | Article |
| id | doaj-art-9d4617063e894723979d3a97542817f2 |
| institution | DOAJ |
| issn | 1664-302X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Microbiology |
| spelling | doaj-art-9d4617063e894723979d3a97542817f22025-08-20T03:18:44ZengFrontiers Media S.A.Frontiers in Microbiology1664-302X2025-06-011610.3389/fmicb.2025.15944101594410Analytical performance and standardization of four HCV RNA assays in China: an evaluation of sensitivity, precision, and genotype inclusivityHao Yan0Hao Yan1Bing Xu2Qinyi Zhang3Qinyi Zhang4Lijun Zhang5Zhihan Fang6Huijun Zhang7Junhang Pan8Wenge Xing9Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, ChinaKey Laboratory of Public Health Detection and Etiological Research of Zhejiang Province, Hangzhou, ChinaNational HIV/AIDS Reference Laboratory, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, ChinaFuyang District Center for Disease Control and Prevention, Hangzhou, ChinaMinhang Hospital, Fudan University, Shanghai, ChinaYangpu Hospital, Tongji University, Shanghai, ChinaInstitute of Laboratory Animal Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College, National Human Diseases Animal Model Resource Center, Beijing, ChinaZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, ChinaNational HIV/AIDS Reference Laboratory, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaIntroductionAccurate, specific, and sensitive detection and quantification of hepatitis C virus (HCV) RNA are critical for diagnosing and managing HCV infections. This study evaluated and compared the performance of four commercially available HCV RNA quantification reagents using standardized serum panels, providing evidence-based insights for clinical applications.MethodsPerformance metrics, including analytical sensitivity, specificity, limit of detection (LOD), precision, genotype inclusivity (GT 1–6), and linearity, were assessed using seven distinct serum panels: basic, analytical specificity, seroconversion, analytical sensitivity, precision, genotype qualification, and linearity panels.ResultsAll reagents demonstrated 100% analytical sensitivity and specificity (95% CI: 79.95–100), with no cross-reactivity to common interfering substances or viruses. LOD values for reagents A, B, C, and D were 25, 50, 50, and 50 IU/ml, respectively. Intra- and inter-assay coefficients of variation (CVs) for HCV genotypes 1–6 ranged from 1.48 to 4.37% and 1.74 to 4.84%, respectively. Strong linear correlations (R2 > 0.95) were observed between measured and expected HCV RNA levels across all reagents.ConclusionThese reagents exhibit high sensitivity, specificity, precision, and accuracy for HCV genotypes 1–6, with a wide linear range, making them suitable for clinical diagnosis and monitoring of HCV infections.https://www.frontiersin.org/articles/10.3389/fmicb.2025.1594410/fullhepatitis C virusRNAperformance assessmentquantitativeserum panel |
| spellingShingle | Hao Yan Hao Yan Bing Xu Qinyi Zhang Qinyi Zhang Lijun Zhang Zhihan Fang Huijun Zhang Junhang Pan Wenge Xing Analytical performance and standardization of four HCV RNA assays in China: an evaluation of sensitivity, precision, and genotype inclusivity Frontiers in Microbiology hepatitis C virus RNA performance assessment quantitative serum panel |
| title | Analytical performance and standardization of four HCV RNA assays in China: an evaluation of sensitivity, precision, and genotype inclusivity |
| title_full | Analytical performance and standardization of four HCV RNA assays in China: an evaluation of sensitivity, precision, and genotype inclusivity |
| title_fullStr | Analytical performance and standardization of four HCV RNA assays in China: an evaluation of sensitivity, precision, and genotype inclusivity |
| title_full_unstemmed | Analytical performance and standardization of four HCV RNA assays in China: an evaluation of sensitivity, precision, and genotype inclusivity |
| title_short | Analytical performance and standardization of four HCV RNA assays in China: an evaluation of sensitivity, precision, and genotype inclusivity |
| title_sort | analytical performance and standardization of four hcv rna assays in china an evaluation of sensitivity precision and genotype inclusivity |
| topic | hepatitis C virus RNA performance assessment quantitative serum panel |
| url | https://www.frontiersin.org/articles/10.3389/fmicb.2025.1594410/full |
| work_keys_str_mv | AT haoyan analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT haoyan analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT bingxu analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT qinyizhang analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT qinyizhang analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT lijunzhang analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT zhihanfang analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT huijunzhang analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT junhangpan analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity AT wengexing analyticalperformanceandstandardizationoffourhcvrnaassaysinchinaanevaluationofsensitivityprecisionandgenotypeinclusivity |