Abstract
BackgroundTwo 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.MethodsWe 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).ResultsBetween 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.ConclusionWe 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.AbbreviationsABS: 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.
Highlights
According to the Global Burden of Disease Study 2010, chronic liver disease (CLD) ranks ninth among the top 10 major disease burden in Malaysia.[1]
We found adequate evidence for the diagnostic validity of a low-cost point of care tests (POCT) for anti-Hepatitis C virus (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
In South-East Asia, it is estimated that 27% and 23% of deaths from CLD are attributable to Chronic Hepatitis B (HBV) and Hepatitis C virus (HCV) infection respectively, while alcohol accounts for another 19% of CLD deaths.[2]
Summary
According to the Global Burden of Disease Study 2010, chronic liver disease (CLD) ranks ninth among the top 10 major disease burden in Malaysia.[1] Each year in Malaysia, about 1500 people died of CLD.[2] Globocan[3] estimated another 1750 people died of liver cancer, the fourth most common cause of cancer deaths in Malaysia after lung, breast, and colorectal cancers. Chronic HBC and HCV are likely major causes of CLD and liver cancer in Malaysia, though admittedly in the absence of population-based epidemiologic studies, these estimates are derived from studies on blood donors, patients on dialysis or from single tertiary institutions[4,5,6,7,8,9,10,11,12,13,14,15,16,17] or were modeled estimates.[18,19,20]
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