Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France

Bottéro, J.; Boyd, Anders; Gozlan, Joël; Lemoine, Maud; Carrat, Fabrice; Collignon, Anne; Boo, Nicolas; Dhotte, Philippe; Varsat, B.; Müller, G; Cha, Olivier; Picard, O; Nau, Jean; Campa, Pauline; Silbermann, Benjamin; Bary, M.; Girard, Pierre‐Marie; Lacombe, Karine

doi:10.1016/j.jhep.2012.11.016

Cited by 62 publications

(81 citation statements)

References 16 publications

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“…To date, the Vikia test has been validated in parallel with Determine in two studies. Both studies found similar sensitivities in Vikia and Determine: 70.7% and 69.3% in Ghana and 96.5% and 93.6% in France, respectively (15,19). Similarly, we did not find a significant difference in sensitivities between the Vikia and Determine tests in study 2 (90.0% and 88.3%, respectively).…”

Section: Njai Et Alsupporting

confidence: 50%

“…However, the majority of these tests were evaluated under laboratory conditions using serum or plasma. Only a few studies assessed the performance of these tests using whole blood from venipuncture (9,12,16,17,19); none of them used capillary blood from finger prick in the field.…”

Section: Discussionmentioning

confidence: 99%

“…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).…”

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confidence: 99%

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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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Section: Njai Et Alsupporting

confidence: 50%

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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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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“…Therefore, the prevalence of HBV in this population could probably be underestimated especially when the sensitivity of the rapid test for HBVvaries between 86% -96% [28].…”

Section: Discussionmentioning

confidence: 97%

Prevalence of Hepatitis B among Students from the University of Lomé, Togo in 2015

Ekouévi¹,

Thomas²,

Dieudonné³

et al. 2017

OJEpi

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Objective: Hepatitis B virus (HBV) is endemic in sub-Saharan Africa where more than 80 million subjects are chronic carriers. However, screening is not systematic in the population and prevalence data are scarce, especially among the youth population. The objective of this study was to estimate the prevalence of HBV and its correlates among first-year University students at the University of Lomé. Study design: A cross-sectional survey was conducted between November 2015 and January 2016 at the University of Lomé during the annual checkup offered to newly enrolled students. Method: A self-administered questionnaire was used to collect data on demographics and sexual behaviors, and rapid tests were used for the detection of Antigen HB S (HBsAg) and HIV in each participant. A logistic regression model was performed to identify factors associated with HBsAg positivity. Results: A total of 800 students (56.2% were men) were screened among 1505 students who participated in the study. The median age was 20 years (IQR: [18 -21]). The overall prevalence of HBsAg was 4.6% (95% CI: [3.2 -6.3]): 5.8% among men and 3.1% among women (p = 0.04). The prevalence of HIV was 0.8; 95%CI [0.3% -1.6%] and one case (0.1%) of coinfection HIV and HBV was identified. Factors associated with HBsAg positivity were male gender [adjusted Odds Ratio (aOR) = 2.08, 95% CI: 1.02 -5.00, p = 0.0447] and ever having a sexual relationship [aOR = 2.44; 95% CI = 1.11 -5.78, p= 0.0264]. Conclusion: This study among university students demonstrates that the prevalence of HBV is high among this population and that there is a need for prevention programs to target this vulnerable population. This is an additional argument How to cite this paper:

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“…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%

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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Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France

Cited by 62 publications

References 16 publications

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

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

Prevalence of Hepatitis B among Students from the University of Lomé, Togo in 2015

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

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Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France

Cited by 62 publications

References 16 publications

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

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

Prevalence of Hepatitis B among Students from the University of Lom&#233;, Togo in 2015

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

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Prevalence of Hepatitis B among Students from the University of Lomé, Togo in 2015