Background Two major challenges in implementing budget-constrained Hepatitis screening and treatment campaign in Malaysia are the availability of low-cost point of care tests (POCT) and nucleic acid tests (NAT) for hepatitis C virus ribonucleic acid (HCV RNA) and hepatitis B virus dioxyribo nucleic acid (HBV DNA). We evaluated the performance of these tests in this study. Methods We conducted a cross-sectional study to evaluate the diagnostic performance of four POCT brands at 12 sites in Malaysia. We assessed the sensitivity and specificity of the POCTs for the detection of HBsAg and anti-HCV in a finger-stick capillary or venepuncture whole-blood samples compared with test results from lab-based enzyme immunoassay (EIA) or chemi-luminescence immunoassay (CLIA) assay as the reference standard. We also conducted a cross-sectional study on 30 to 139 serum specimen panel to evaluate the diagnostic performance of a low-cost in-house Applied Biosystem ® TaqMan real-time polymerase chain reaction (PCR) assay (ABS) for the detection of HCV RNA and HBV DNA, compare with Roche Cobas ® Ampliprep/TaqMan assay (COBAS). Results Between March and December 2017, we enroll 295 participants for the evaluation of POCT for HBsAg and another 307 participants for POCT anti-HCV evaluation. Three of the four POCT brands dropped out of evaluation early on account of sub-optimal sensitivity. The sensitivity of the remaining POCT for HBsAg was 95.2%and specificity 100%, while the POCT for anti-HCV has a sensitivity of 98.1% and specificity 100%. Hepatitis B virus dioxyribo nucleic acid and HCV RNA concentrations detected by the ABS were systematically higher than those measured by COBAS (mean bias +0.10 and +0.17 log10 IU/mL respectively). The 95% limits of agreement between the two assays are -1.28 to 1.47 log10 IU/mL for HBV DNA and –0.41 to 0.75 log10 IU/mL for HCV RNA. Conclusion We found adequate evidence for the diagnostic validity of a low-cost POCT for anti-HCV and HBsAg, as well as for an in-house nucleic acid tests (NAT), to provide support for their broader use in our Hepatitis screening and treatment campaign. Abbreviations ABS: Applied Biosystem ® TaqMan real-time PCR assay, CI: Confidence interval, CLD: Chronic liver disease, CLIA: Chemi-luminescence immunoassay, COBAS: Roche Cobas ® Ampliprep/ TaqMan assay, DAA: Direct Acting Anti-Viral drugs, EIA: Enzyme immunoassay, HBV: Hepatitis B virus, HCV: Hepatitis C virus, HFPM: Hepatitis Free Pahang Malaysia, LOA: Limits of agreement, LOD: Limit of detection, MOH: Ministry of Health, Malaysia, NAT: Nucleic Acid Tests, POCT: Point of Care Tests, SD: Standard deviation, WHO: World Health Organization How to cite this article: Radzi AHM, Tan SS, Mohamed R, Jaya F, Senamjit K, Aun AC, Kutty GA, Wong HS, Abd...
Background: Although there are thousands of patients with hepatocellular carcinoma (HCC) in Bangladesh, almost there is no nationwide recommendations for therapeutic maneuver for HCC patients. As most of the HCC patients of Bangladesh are diagnosed late, patients with advanced HCC with large and multiple HCC nodules represent the usual presentation of HCC. The study is presented here to assess the effects of a combined therapy of transarterial chemoembolization (TACE) and sorafenib in advanced HCC patients. Materials and methods: A total of 77 patients with advanced HCC were enrolled in this study. All of them had advanced HCC with variable etiologies and clinical conditions. All patients were treated by TACE and also given systemic sorafenib at the same time. The patients were checked 1 and 3 months after therapy commencement. Results: Out of 77 patients, 18 patients died within 1 month and additional 15 patients died within 3 months after therapy commencement. Thus, there remains 44 surviving patients after 3 months. When different parameters of dead patients and survived patients were compared, no specific parameters dictated the factors about overall survival of more than 3 months. Discussion: This is the first approach to initiate an invasive and a systemic therapy for treatment of advanced HCC in Bangladesh. Further follow-up of patients and their long-term overall survival may cast some lights about the role of these therapies in Bangladeshi HCC patients.
Background: Chronic liver disease (CLD) is common in Bangladesh; however, a major bulk remains as cryptogenic CLD as they remain devoid of known pathological agents leading to have a check of Kayser-Fleischer (K-F) rings for possible Wilson's disease (WD) and many of these patients develop complications such as cirrhosis of liver and hepatocellular carcinoma. However, there remains considerable proportions of CLD patients with undefined etiology (cryptogenic CLD) and these patients cannot be provided effective therapy based on etiological factors. Here, the proportion of WD among cryptogenic CLD patients in Bangladesh has been evaluated to improve the management of CLD and reduce complications. Materials and methods: A total of 941 patients with cryptogenic CLD [negative for hepatitis viruses, alcohol, nonalcoholic fatty liver disease (NAFLD), drug, and autoimmunity] were enrolled in the study. To assess if they have been suffering from WD, the levels of copper in 24-hour urine were evaluated. Definitive WD was diagnosed when 24-hour urinary copper output was >100 μg and strongly indicative WD patients excreted >40 μg of copper in 24 hours. Results: Out of 941 patients with cryptogenic CLD, 212 patients were diagnosed as definitive WD and 239 patients as strongly indicative WD on the basis of 24-hours copper excretion. The age distribution ranging of the patients varied from 1 year to 90 years. There was a male predominance. Considerable numbers of WD patients had previous history of jaundice. Kayser-Fleischer rings were mostly uncommon and detected in five patients with WD only. Discussion: Wilson's disease is not a rare entity in Bangladesh; rather, it seems to be fairly common among CLD patients. A country-wide epidemiological survey should be conducted for diagnosis of WD in Bangladesh to provide a proper management strategy for these huge numbers of WD patients. In fact, most of the WD patients are unaware of their diagnosis and the general physicians are equally unaware of diagnosis and management of WD.
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