Field performance of the Determine HBsAg point-of-care test for diagnosis of hepatitis B virus co-infection among HIV patients in Zambia

Chisenga, Caroline Cleopatra; Musukuma, Kalo; Chilengi, Roma; Zürcher, Samuel; Munamunungu, Virginia; Siyunda, Alice; Ojok, David; Bauer, Sophie; Wandeler, Gilles; Vinikoor, Michael J.

doi:10.1016/j.jcv.2017.11.005

Cited by 15 publications

(10 citation statements)

References 17 publications

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“…Whereas, one step HCV test strip (Nantong Diagnos Technology Co., Ltd., China) was used to detects antibodies against HCV following the instructions of the manufacturer. Samples found positive for HBV infection by one step HBsAg test strip were further screened using qualitative immunoassay Alere Determine TM HBsAg (Alere Inc., Massachusetts, USA) which is more specific but less sensitive than the One Step HBsAg test [23–25]…”

Section: Methodsmentioning

confidence: 99%

Community-based Sero-prevalence of Hepatitis B and C Infections in South Omo Zone, Southern Ethiopia

Woldegiorgis

Erku

Medhin

et al. 2019

Preprint

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16Background: Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) are the leading causes of 17 liver-related morbidity and mortality throughout the world. The magnitude of HBV and HCV 18 infections in Ethiopia has not been well studied at community level. This study aimed at 19 investigating the sero-prevalence and associated risk factors of HBV and HCV among HBV 20 unvaccinated community members in South Omo Zone, Southern Ethiopia. 21 Methods: A community-based cross-sectional study was conducted in three districts from March 22 to May 2018. Structured questionnaire was used to collect relevant clinical and socio-23 demographic data. Three milliliter of blood sample was collected from each study participant and 24 screened for HBV and HCV using one step hepatitis B surface antigen (HBsAg) test strip and one 25 step HCV test strip, respectively. Samples found positive for HBsAg were further tested using 26 immunoassay of Alere Determine TM HBsAg (Alere Inc., USA). Data was analyzed using SPSS 27 version 25.0. 28 Results: A total of 625 (51.4% males, age 6-80 years, mean age ± SD = 30.83 ± 13.51 years) 29 individuals participated in the study. The sero-prevalence for HBV infection was 8.0% as 30 detected using one step HBsAg test strip, while it was 7.2% using Alere Determine TM HBsAg 31 test. The sero-prevalence for HCV infection was 1.9%. Two (0.3%) of the participants were 32 seropositive for both HBV and HCV infections. High sero-prevalence for HBV infection was 33 associated with weakness and fatigue (AOR = 5.20; 95% CI: 1.58, 17.15), while high sero-34 prevalence of HCV infection was associated with age group between 46 and 65 years (AOR = 35 13.02; 95% CI: 1.11, 152.41).36 Conclusion: this study revealed higher-intermediate endemicity level of HBV infection and low 37 to intermediate endemicity level of HCV infection in the study area. Clinical symptoms like 38 weakness and fatigue were found to be indictors for HBV infection, while individuals in the age 39 group between 46 and 65 years were at higher risk for HCV infection. Provision of community-40 based health education, vaccination, mass screening and providing treatment would have utmost 41 importance in reducing the transmission of these diseases in the present study area. 42 2 43 E viruses. Among these, hepatitis B virus (HBV) and hepatitis C virus (HCV) are the most 48 common causes of viral hepatitis [2]. 49 Both HBV and HCV can be transmitted through sexual, blood or vertically from mother-to-child 50 [3]. Thus, individuals who require blood transfusion, those who have multiple sexual partners 51 and infants born to HBV or HCV infected mothers are at a high-risk for acquiring HBV or 52 HCV infection [4]. Both viruses can cause acute and chronic infection of the liver [5, 6]. Chronic 53 HBV and HCV infections are the leading causes of liver-related morbidity and mortality [7, 8]. 54 Between 15% and 40% of chronically infected individuals can develop serious liver disease and 55 transmit the viruses to others [9, 10]. Globally, about 257 m...

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Section: Methodsmentioning

confidence: 99%

Community-based Sero-prevalence of Hepatitis B and C Infections in South Omo Zone, Southern Ethiopia

Woldegiorgis

Erku

Medhin

et al. 2019

Preprint

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“…Using a common protocol, we collected information on the following demographic, clinical and behavioural characteristics: age, sex, marital status, education level, CD4 cell count, body mass index, transaminases and ART history. Tobacco consumption was reported as “never smoker” or “current or past smoker.” Viral hepatitis infections were assessed using rapid diagnostic tests: Determine ® (Alere, Waltham, MA, USA) for hepatitis B surface antigen (HBsAg) and Oraquick ® (Orasure, Bethlehem, PA, USA) for anti‐hepatitis C virus (HCV) antibodies, as these tests have shown relatively good diagnostic accuracy, including a validation study performed at our Zambian study site .…”

Section: Methodsmentioning

confidence: 99%

“…Tobacco consumption was reported as "never smoker" or "current or past smoker. " Viral hepatitis infections were assessed using rapid diagnostic tests: Determine â (Alere, Waltham, MA, USA) for hepatitis B surface antigen (HBsAg) and Oraquick â (Orasure, Bethlehem, PA, USA) for anti-hepatitis C virus (HCV) antibodies, as these tests have shown relatively good diagnostic accuracy, including a validation study performed at our Zambian study site [19,20].…”

Section: Study Measurementsmentioning

confidence: 99%

High prevalence of binge drinking among people living with HIV in four African countries

et al. 2018

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IntroductionExcessive alcohol consumption leads to unfavourable outcomes in people living with HIV (PLHIV), including reduced adherence to antiretroviral therapy (ART) and engagement into care. However, there is limited information on alcohol consumption patterns among PLHIV in sub‐Saharan Africa.MethodsUsing a cross‐sectional approach, the Alcohol Use Disorders Identification Test (AUDIT‐C) was administered to PLHIV attending HIV clinics in Côte d'Ivoire, Togo, Senegal and Zambia (2013 to 2015). Hazardous drinking was defined as an AUDIT‐C score ≥4 for men or ≥3 for women, and binge drinking as ≥6 drinks at least once per month. The prevalence of binge drinking was compared to estimates from the general population using data from the World Health Organization. Factors associated with binge drinking among persons declaring any alcohol use in the past year were assessed using a logistic regression model to estimate odds ratio (OR) and their corresponding 95% confidence intervals (CI).ResultsAmong 1824 PLHIV (median age 39 years, 62.8% female), the prevalence of hazardous alcohol use ranged from 0.9% in Senegal to 38.4% in Zambia. The prevalence of binge drinking ranged from 14.3% among drinkers in Senegal to 81.8% in Zambia, with higher estimates among PLHIV than in the general population. Male sex (OR 2.4, 95% CI 1.6 to 3.7), tobacco use (OR 1.7, 95% CI 1.0 to 2.9) and living in Zambia were associated with binge drinking.ConclusionsAlcohol consumption patterns varied widely across settings and binge drinking was more frequent in HIV‐positive individuals compared to the general population. Interventions to reduce excessive alcohol use are urgently needed to optimize adherence in the era of universal ART.

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“…A 2017 meta-analysis [ 31 ] including 9 studies with 7730 samples showed a pooled sensitivity of 90.8% and specificity of 99.1% using Determine. Though most studies [ 32 , 33 , 34 , 35 , 36 , 37 , 38 ] showed high clinical sensitivity of 89–100% in the general population, the reported sensitivity varied widely in HIV-infected populations (56–100%) [ 39 , 40 , 41 , 42 , 43 , 44 ]. The cause of the reported lower sensitivity in HIV-coinfected populations [ 39 , 40 , 43 , 44 ] is unclear, but potential reasons may include the cross reaction of HIV-reverse transcriptase inhibitors and hepatitis B virus, a higher rate of occult hepatitis B infection in early HIV cohorts, a higher reported rate of HBsAg loss in both untreated and treated HIV-infected populations and the use of tenofovir-based HIV regimens that effectively suppress hepatitis B virus DNA levels and a large decline in HBsAg titres [ 31 , 45 , 46 ].…”

Section: Poc Tests For Hepatitis B and Their Clinical Performancementioning

confidence: 99%

Point-of-Care Tests for Hepatitis B: An Overview

Xiao

Thompson

Howell

2020

Cells

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Despite the heavy disease burden posed by hepatitis B, around 90% of people living with hepatitis B are not diagnosed globally. Many of the affected populations still have limited or no access to essential blood tests for hepatitis B. Compared to conventional blood tests which heavily rely on centralised laboratory facilities, point-of-care testing for hepatitis B has the potential to broaden testing access in low-resource settings and to engage hard-to-reach populations. Few hepatitis B point-of-care tests have been ratified for clinical use by international and regional regulatory bodies, and countries have been slow to adopt point-of-care testing into hepatitis B programs. This review presents currently available point-of-care tests for hepatitis B and their roles in the care cascade, reviewing evidence for testing performance, utility, acceptability, costs and cost-effectiveness when integrated into hepatitis B diagnosis and monitoring programs. We further discuss challenges and future directions in aspects of technology, implementation, and regulation when adopting point-of-care testing in hepatitis B programs.

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Field performance of the Determine HBsAg point-of-care test for diagnosis of hepatitis B virus co-infection among HIV patients in Zambia

Cited by 15 publications

References 17 publications

Community-based Sero-prevalence of Hepatitis B and C Infections in South Omo Zone, Southern Ethiopia

Community-based Sero-prevalence of Hepatitis B and C Infections in South Omo Zone, Southern Ethiopia

High prevalence of binge drinking among people living with HIV in four African countries

Point-of-Care Tests for Hepatitis B: An Overview

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