Hepatitis Screening and Treatment Campaign in Malaysia-Validation of Low-cost Point of Care Screening Tests and Nucleic Acid Tests for Hepatitis B and C.

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 OrganizationHow to cite this article: Radzi AHM, Tan SS, Mohamed R, Jaya F, Senamjit K, Aun AC, Kutty GA, Wong HS, Abdullah R, Seman MR, Mahtab MA, Morad Z, Lim TO. Hepatitis Screening and Treatment Campaign in Malaysia-Validation of Low-cost Point of Care Screening Tests and Nucleic Acid Tests for Hepatitis B and C. Euroasian J Hepatogastroenterol, 2018;8(2):101-107.

A first study on the incidence and prevalence of IBD in Malaysia--results from the Kinta Valley IBD Epidemiology Study.

BACKGROUND: Inflammatory bowel disease [IBD] is known to be rare in the Asia Pacific region but epidemiological studies are scarce. METHODS: Kinta Valley [Ipoh] was chosen as the sample population. Malaysia has a multiethnic population consisting of Malays, Chinese, and Indians. New cases over 2 years were prospectively captured as well as all known existing cases. Total numbers of the population as a whole and of each ethnic group were obtained. Incidence, prevalence, and mean incidence over two decades were then calculated. RESULTS: There were 10 new cases of IBD diagnosed from April 2011 to April 2013. The crude incidence rates of IBD, ulcerative colitis [UC], and Crohn's disease[CD], respectively, were 0.68, 0.46, and 0.20 per 100,000 persons. The highest incidence was among the Indians, 1.91 compared with 0.35 and 0.63 per 100,000 persons among the Malays and the Chinese, respectively. The mean incidence of IBD has increased steadily from 0.07 to 0.69 per 100,000 person-years over the past two decades. The UC:CD ratio was 8:1 from 1990 to 2000 and 3.6:1 from 2000 to 2010. The prevalence rates of IBD, UC, and CD, respectively, were 9.24, 6.67, and 2.17 per 100,000 persons. The highest prevalence also was among the Indians: 24.91 compared with 7.00 and 6.90 per 100,000 persons among the Malay and Chinese races, respectively. CONCLUSIONS: The incidence and prevalence rates of IBD are low in Malaysia but the incidence appears to be increasing and marked racial differences exist. As in other Asian countries, the incidence of CD is increasing at a more rapid rate relative to UC.

Stroke patterns in Northeast Malaysia: a hospital-based prospective study.

All patients with a first-ever stroke admitted to the HUSM (Hospital Universiti Sains Malaysia) from 1997 to 1998 were included in this study. All risk factors were determined and analysed prospectively. There were 158 cases of stroke admitted during the study period. The majority of the patients were Malays (86.1%), with a male preponderance. The mean age (SD) of the patients with stroke was 59.3 (12.28) years. Hypertension was present in both cerebral infarct and intracerebral haemorrhage patients at almost the same rate (65.2 and 69.2%, respectively). The overall mortality was 37%, and most patients died in the 1st month after stroke (34%). We hope this study will highlight the problems associated with the presentation and management of stroke in Southeast Asia.