| Title | Traceability, reproducibility and clinical evaluation of Sansure Realtime HCV RNA assay |
| Authors | Huang, Xiangbo Deng, Zhongping Long, Lu Chen, Jinjun Tan, Deming Zhu, Liyan Fan, Xueying Shen, Tao Lu, Fengmin |
| Affiliation | Peking Univ, Sch Basic Med Sci, Dept Microbiol, 38 Xueyuan Rd, Beijing 100191, Peoples R China. Peking Univ, Sch Basic Med Sci, Ctr Infect Dis, 38 Xueyuan Rd, Beijing 100191, Peoples R China. Peking Univ, Acad Adv Interdisciplinary Studies, Beijing 100871, Peoples R China. Southern Med Univ, Dept Infect Dis, Nanfang Hosp, Guangzhou 510515, Guangdong, Peoples R China. Cent S Univ, Dept Infect Dis, Xiangya Hosp, Changsha 410008, Hunan, Peoples R China. Peking Univ, Sch Basic Med Sci, Dept Microbiol, 38 Xueyuan Rd, Beijing 100191, Peoples R China. Shen, T (reprint author), Peking Univ, Sch Basic Med Sci, Ctr Infect Dis, 38 Xueyuan Rd, Beijing 100191, Peoples R China. |
| Keywords | Hepatitis C virus RNA Traceability Reproducibility Correlation GENOTYPE 1 INFECTION C VIRUS-INFECTION HEPATITIS-B EPIDEMIOLOGY BOCEPREVIR TELAPREVIR |
| Issue Date | 2016 |
| Publisher | BMC INFECTIOUS DISEASES |
| Citation | BMC INFECTIOUS DISEASES.2016,16. |
| Abstract | Background: Accurate quantitative detection of hepatitis C virus (HCV) RNA is critical for diagnosis of acute or chronic HCV infection, and for follow-up of virologic response during HCV targeted therapy. In the present study, traceability and reproducibility of a novel China-certified domestic Sansure HCV RNA diagnostic assay (Sansure, Changsha, Hunan, China) was evaluated and the clinical performance of this assay was also analyzed. Methods: Traceability of the Sansure HCV RNA assay to the WHO international standard for HCV (genotype 1a) was detected across multiple centers. Reproducibility, accuracy (the differences of observed average concentrations and expected concentrations) and precision were assessed using series dilutions of World HCV RNA performance panel WWHV303-02 (HCV-1b), WWHV303-04(HCV-2a), WWHV303-11(HCV-3a) and WWHV303-19 (HCV-6a). In addition, both Sansure HCV RNA and CAP/CTM HCV (Roche, Branchburg, NJ, USA) assays were used to detect HCV RNA in 346 EDTA anti-coagulated plasma samples from previous HCV-infected patients, during and after antiviral therapy. Results: The Sansure assay showed good traceability by agreeing with the HCV-1a WHO standard across all five concentrations tested (25, 50, 100, 1000, 10000 IU/ml). The differences between observed average concentrations and expected concentrations were all within 0.2 log(10) IU/ml. HCV WWHV303 standards across 4 HCV genotypes (1b, 2a, 3a and 6a) were used for evaluation of reproducibility and the accuracy of the test were all within 0.2 log10 IU/ml. The inter-assay variations across the above 4 HCV genotypes were all less than 0.03 on each evaluated concentration, indicating good precision of Sansure HCV RNA assay. In clinical practice, concordant results were determined in 99.42 % (344/346) samples (215 positive and 129 negative samples). Two specimens with negative HCV RNA results by Sansure assay were detected positive by CAP/CTM HCV test. Correlation analysis indicated a significantly positive correlation in detected HCV RNA concentrations (r = 0.9439, P < 0.0001). HCV RNA levels in 95.35 % (205/215) specimens were within mean difference +/- 1.96 SD as tested by both assays. Conclusions: With the advantages of traceability, reproducibility and lower price, Sansure HCV RNA assay represented an alternative option for HCV RNA detection in hospital and medical institution in China. |
| URI | http://hdl.handle.net/20.500.11897/435118 |
| ISSN | 1471-2334 |
| DOI | 10.1186/s12879-016-1390-9 |
| Indexed | SCI(E) PubMed |
| Appears in Collections: | 基础医学院 前沿交叉学科研究院 |
