Reliability of rapid testing for hepatitis B in a region of high HIV endemicity

Davies, Julia; Oosterhout, Joep J. van; Nyirenda, Mulinda; Bowden, James H.; Moore, Elizabeth; Hart, Ian; Zijlstra, E.E.; Chaponda, Mas; Faragher, Brian; Beeching, Nicholas J.; Beadsworth, Mike

doi:10.1016/j.trstmh.2009.10.010

Cited by 20 publications

(25 citation statements)

References 8 publications

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“…Four studies had included cross reactive sera in sera panels. 35,37,46,50 Four studies had described patient's characteristics. 11,16,40,50 Sample size varied from 25 to 3956.…”

Section: Literature Searchmentioning

confidence: 99%

“…Neutralization test for HBsAg (CDC guideline for HBsAg testing by EIA), HBsAg quantification or molecular testing for HBV were employed in only 6 studies. 11,12,41,46,48,49 All the studies administered the same reference test to all patients, thus avoiding partial or differential verification bias.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Two studies reported a financial relationship with or received funding from the industry, 17,35 3 explicitly declared no conflict of interest, 37,42,46 and 2 were independent evaluation by International Organizations. 11,12 Most remaining studies omitted disclosure of conflict of interest.…”

Section: Conflict Of Interestmentioning

confidence: 99%

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Accuracy of Rapid Point-of-Care Diagnostic Tests for Hepatitis B Surface Antigen—A Systematic Review and Meta-analysis

Khuroo

Khuroo²,

Khuroo³

2014

Journal of Clinical and Experimental Hepatology

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Background: Rapid 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. Methods: Literature search was done with the help of a metasearch engine Mett a, 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. Results: Twenty-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. Conclusions: Tests with better analytical sensitivity need to be developed and their feasibility and outcomes in various clinical settings need to be addressed. ( J CLIN EXP HEPATOL 2014;4:226-240)

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“…Four studies had included cross reactive sera in sera panels. 35,37,46,50 Four studies had described patient's characteristics. 11,16,40,50 Sample size varied from 25 to 3956.…”

Section: Literature Searchmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

See 1 more Smart Citation

Accuracy of Rapid Point-of-Care Diagnostic Tests for Hepatitis B Surface Antigen—A Systematic Review and Meta-analysis

Khuroo

Khuroo²,

Khuroo³

2014

Journal of Clinical and Experimental Hepatology

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“…Taken together, HBsAg POC tests seem suitable for community-based and large-scale screening. However, most of the studies which validated their performance were done at the facility level and among specific populations, i.e., blood donors (8)(9)(10), hospital patients (11)(12)(13), or HIV-infected people (14)(15)(16)(17)(18). Although one study in France investigated the accuracy of HBsAg POC tests in the general population, the tests were performed in health centers using whole blood collected by venipuncture (19).…”

mentioning

confidence: 99%

Validation of Rapid Point-of-Care (POC) Tests for Detection of Hepatitis B Surface Antigen in Field and Laboratory Settings in the Gambia, Western Africa

et al. 2015

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f Hepatitis B virus (HBV) infection is a leading cause of death in sub-Saharan Africa (SSA). Point-of-care tests for hepatitis B surface antigen (HBsAg) could be an ideal tool for a large-scale HBV screening/treatment program in SSA. Using data from the PROLIFICA (Prevention of Liver Fibrosis and Cancer in Africa) program, we conducted a cross-sectional study to assess the diagnostic accuracy of three point-of-care tests (Determine, Vikia, and Espline) for the detection of HBsAg in the field or a laboratory setting in the Gambia. In the field, we used finger-prick whole blood for the Determine and Vikia tests and dried blood spots for the reference standard test (AxSYM HBsAg enzyme-linked immunosorbent assay [ELISA]). In the laboratory we used serum for the Determine, Espline, and reference test (Architect chemiluminescent microparticle immunoassay). Of 773 participants recruited at the community and 227 known chronic HBV carriers (1,000 subjects in total), 293 were positive for HBsAg. The sensitivity and specificity of the Determine test were 88.5% and 100% in the field and 95.3% and 93.3% in the laboratory setting, respectively. The sensitivity and specificity were 90.0% and 99.8% for the Vikia test (in the field) and 93.9% and 94.7% for the Espline test (in the laboratory). There was no evidence that one kit was better than another. Most of the patients with false-negative results (18/19) were classified as inactive chronic carriers. In summary, the three point-of-care tests had acceptable ranges of diagnostic accuracy. These tests may represent accurate, rapid, and inexpensive alternatives to serology testing for the screening of HBV infection at field level in SSA.

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“…The reason for this may be the higher proportion of relatively low-titer reactive samples and the longer window period in the early phases of infection. However also for HbSAg and HCVAb there are kits that show promising results in terms of diagnostic accuracy [60][61][62][63][64][65] and a HbSAg RDT has been recently CE marked as it achieves the requested sensitivity of at least 0.125 I.U/mL [66].…”

Section: Transfusion Transmitted Infections -"Ttis"-screeningmentioning

confidence: 99%

Point of Care Testing and Transfusion Safety in Resource Limited Settings: A Review

Musi¹

2015

J Blood Disord Transfus

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Worldwide, one of the fastest growing aspects of clinical laboratory testing is point of care testing (POCT). Decentralized patient care and access to testing in under-served areas are key elements in the evolving expansion of POCT. Several available POCT devices can potentially contribute to safer transfusion practices in resourcelimited settings. Only "rapid diagnostic tests" and some simple hemoglobinometers are normally encountered in the peripheral hospitals of low income countries. Strengths, weaknesses and barriers of large scale utilization of POCT in transfusion medicine are discussed.

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Reliability of rapid testing for hepatitis B in a region of high HIV endemicity

Cited by 20 publications

References 8 publications

Accuracy of Rapid Point-of-Care Diagnostic Tests for Hepatitis B Surface Antigen—A Systematic Review and Meta-analysis

Accuracy of Rapid Point-of-Care Diagnostic Tests for Hepatitis B Surface Antigen—A Systematic Review and Meta-analysis

Validation of Rapid Point-of-Care (POC) Tests for Detection of Hepatitis B Surface Antigen in Field and Laboratory Settings in the Gambia, Western Africa

Point of Care Testing and Transfusion Safety in Resource Limited Settings: A Review

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