title: Traceability, reproducibility and clinical evaluation of Sansure Realtime HCV RNA assay.
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, 10,000 IU/ml). The differences between observed average concentrations and expected concentrations were all within 0.2 log10 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.
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
authors.forename: Xiangbo
authors.initials: X
authors.lastname: Huang
authors.affiliation: Academy for Advanced Interdisciplinary Studies, Peking University, Beijing, 100871, China.
authors.forename: Zhongping
authors.initials: Z
authors.lastname: Deng
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
authors.forename: Lu
authors.initials: L
authors.lastname: Long
authors.affiliation: Department of Infectious Diseases, Nanfang Hospital of Southern Medical University, Guangzhou, 510515, China.
authors.forename: Jinjun
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of Infectious Diseases, Xiangya Hospital of Central South University, Changsha, 410008, China.
authors.forename: Deming
authors.initials: D
authors.lastname: Tan
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
authors.forename: Liyan
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
authors.forename: Xueying
authors.initials: X
authors.lastname: Fan
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China. taoshen@hsc.pku.edu.cn.
authors.forename: Tao
authors.initials: T
authors.lastname: Shen
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China.
authors.forename: Fengmin
authors.initials: F
authors.lastname: Lu
mesh_terms: D002681:China; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000821:virology*; D006801:Humans; D012367:RNA, Viral / Q000235:genetics*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
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