Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Xiao Y

PROVIDER: S-EPMC7650625 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Xiao Yinzong Y Thompson Alexander J AJ Howell Jessica J

Cells 20201002 10

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-o ...[more]

PMID: 33023265

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Project description:BackgroundPoint-of-care tests provide a plausible diagnostic strategy for hepatitis C infection in economically impoverished areas. However, their utility depends upon the overall performance of individual tests.MethodsA literature search was conducted using the metasearch engine Mett?, a query interface for retrieving articles from five leading medical databases. Studies were included if they employed point-of-care tests to detect antibodies of hepatitis C virus and compared the results with reference tests. Two reviewers performed a quality assessment of the studies and extracted data for estimating test accuracy.FindingsThirty studies that had evaluated 30 tests fulfilled the inclusion criteria. The overall pooled sensitivity, specificity, positive likelihood-ratio, negative likelihood-ratio and diagnostic odds ratio for all tests were 97.4% (95% CI: 95.9-98.4), 99.5% (99.2-99.7), 80.17 (55.35-116.14), 0.03 (0.02-0.04), and 3032.85 (1595.86-5763.78), respectively. This suggested a high pooled accuracy for all studies. We found substantial heterogeneity between studies, but none of the subgroups investigated could account for the heterogeneity. Genotype diversity of HCV had no or minimal influence on test performance. Of the seven tests evaluated in the meta-regression model, OraQuick had the highest test sensitivity and specificity and showed better performance than a third generation enzyme immunoassay in seroconversion panels. The next highest test sensitivities and specificities were from TriDot and SDBioline, followed by Genedia and Chembio. The Spot and Multiplo tests produced poor test sensitivities but high test specificities. Nine of the remaining 23 tests produced poor test sensitivities and specificities and/or showed poor performances in seroconversion panels, while 14 tests had high test performances with diagnostic odds ratios ranging from 590.70 to 28822.20.ConclusionsPerformances varied widely among individual point-of-care tests for diagnosis of hepatitis C virus infection. Physicians should consider this while using specific tests in clinical practice.

Project description:BackgroundRapid point-of-care tests provide plausible diagnostic strategy for hepatitis B surface antigen (HBsAg) in low resource areas. However, their utility depends upon their overall performance. Our objective was to meta-analyze the diagnostic accuracy of rapid point-of-care tests for HBsAg.MethodsLiterature search was done with the help of a metasearch engine Mett?, a query interface for retrieving articles from five leading medical databases. Studies that employed rapid point-of-care tests for detection of HBsAg and compared the results with reference test were included. Two reviewers performed quality assessment of the studies and extracted data for estimating test accuracy. Twenty-seven studies were meta-analyzed and stratified by multiple parameters.ResultsTwenty-seven studies had evaluated 49 test brands and generated 76 data points. Sensitivity of individual tests varied widely and were heterogeneous (range 43.5%-99.8%); while specificity estimates were more robust and close to 100% (range 90%-100%). Overall pooled sensitivity, specificity, positive likelihood ratio (LR), negative LR and diagnostic odds ratio for all tests were 97.1% (95% CI, 96.1%-97.9%), 99.9% (CI, 99.8%-100%), 118.4 (CI, 84.7-165.5), 0.032 (CI, 0.023-0.045) and 4094.7 (CI, 2504.1-6600.8) respectively. This suggested high pooled accuracy for all studies. We found substantial heterogeneity between studies. Three factors (study location, reference standard and study score) appeared most strongly associated with test estimates and observed heterogeneity. The Determine test showed consistency in performance in studies done across developed and developing countries and the Determine and the BinaxNOW tests had significantly higher estimates than pooled estimates of remaining tests. Tests revealed analytical sensitivity of 4 IU/ml against manufacturer's claim of 0.5 IU/ml; reduced sensitivity with HBsAg mutants and poor performance in seroconversion panels.ConclusionsTests with better analytical sensitivity need to be developed and their feasibility and outcomes in various clinical settings need to be addressed.

Dataset Information

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

Publications

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

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