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Definitions and descriptions of acute-on-chronic liver failure (ACLF) vary between Western and Eastern types, and alcoholism and hepatitis B virus (HBV) are, respectively, the main etiologies. To determine whether there are unified diagnostic criteria and common treatment programs for different etiologies of ACLF, a multicenter prospective cohort with the same inclusion criteria and disease indicators as those used in the European Consortium Acute-on-Chronic Liver Failure in Cirrhosis Study is urgently needed in Asia, where the prevalence of HBV is high. A multicenter prospective cohort of 2,600 patients was designed, drawing from 14 nationwide liver centers from tertiary university hospitals in China, and 2,600 hospitalized patients with chronic liver disease (both cirrhotic and noncirrhotic) of various etiologies with acute decompensation or acute hepatic injury were continuously recruited from January 2015 to December 2016. Data were collected during hospitalization, and follow-ups were performed once a month, with plans to follow all patients until 36 months after hospital discharge. Of these patients, 1,859 (71.5%) had HBV-related disease, 1,833 had cirrhotic disease, and 767 had noncirrhotic disease. The numbers and proportions of enrolled patients from each participating center and the baseline characteristics of the patients with or without cirrhosis are presented. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]