Evaluation of a New Hepatitis B Virus Surface Antigen Rapid Test with Improved Sensitivity

Lin, Yaw Huei; Wang, Yichuan; Loua, André; Day, Gwo-Jen; Qiu, Yan; Nadala, Cesar; Allain, Jean‐Pierre; Lee, Helen H.

doi:10.1128/jcm.00498-08

Cited by 52 publications

(52 citation statements)

References 14 publications

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“…We believe that the high accuracy of some tests may have been obscured. For example, Lin et al 17 made head-to-head comparison of DRW test and Determine and found DRW did better in overall accuracy, analytical and seroconversion panels.…”

Section: Discussionmentioning

confidence: 99%

“…[11][12][13][15][16][17] Data from 2 studies had duplicate publications. Official report of International Consortium for Blood Safety 2007 (ICBS, 12 ) was Figure 1 Flow diagram of study selection.…”

Section: Literature Searchmentioning

confidence: 99%

“…11,16,40,50 Sample size varied from 25 to 3956. For defining analytical sensitivity of the tests, 5 studies employed low titer sera panels 11,12,[15][16][17] and 1 included seroconversion sera panels. 11 None of the studies had included sera from general population, patients with acute hepatitis syndrome, fulminant hepatic failure or HBV infected patients on antiviral therapy.…”

Section: Literature Searchmentioning

confidence: 99%

“…We believe complete transparency regarding the handling of inconclusive results in the analysis phase is essential for the reader to understand how key summary statistics have been derived. 14 Analytical sensitivity of the tests based on low titer and seroconversion panels performed in several included studies [15][16][17] were not evaluated, which affected the conclusions made on the accuracy of the tests under consideration. Authors did not evaluate heterogeneity (differences in reported estimates among studies) and its potential sources, an important component in metaanalysis studies.…”

mentioning

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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Section: Discussionmentioning

confidence: 99%

Section: Literature Searchmentioning

confidence: 99%

Section: Literature Searchmentioning

confidence: 99%

mentioning

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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“…However, high specificity enzyme-linked immunosorbent assays (ELISAs) are still commonly used [4,5,10,11]. Low cost ELISA systems allow fast screening of a large number of samples even though many researches are still focused on increasing the sensitivity and the specificity of HBsAg detection assays [9,[12][13][14]. However, most of them are based on the conventional ELISA system, relying on a cumbersome and time-consuming procedure.…”

Section: Article; Medical Biotechnology (Mb)mentioning

confidence: 99%

Cloning of anti-HBsAg single-chain variable fragments from hybridoma cells for one-step ELISA

Erdağ

Balcıoğlu

Bahadır

et al. 2017

Biotechnology & Biotechnological Equipment

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Hepatitis B virus (HBV) infection is a worldwide health problem. More than 400 million people are chronic HBV carriers in the world. Infected individuals are at a high risk of developing liver cirrhosis and hepatocellular carcinoma as the main consequences of HBV. The discoveries of fast diagnostic systems and new therapeutic applications are crucial in the fight against viral hepatitis. In this paper we present the generation of a single-chain variable fragment (scFv) from a mouse monoclonal antibody specific to the HBV surface antigen (HBsAg) and demonstrate its expression as a bacterial alkaline phosphatase (AP) fusion protein. In this study, we constructed scFvs from hybridoma cells expressing HBsAg-specific antibody using phage display technology and expressed them in Escherichia coli. The anti-HBsAg scFvs were inserted into pQE-2 vector to produce scFv antibody genetically fused to bacterial AP. Reproducibility of the recombinant HBsAg-scFv fusion protein was tested using Enzyme-linked Immunosorbent Assay (ELISA). Present preliminary findings indicate that the anti-HBsAg-scFv AP conjugate could be further used for the development of one-step ELISA for the detection of HBV.

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A signal amplification system on a lateral flow immunoassay detecting for hepatitis e‐antigen in human blood samples

Zhang

et al. 2019

Journal of Medical Virology

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Hepatitis B e-antigen (HBeAg) is the secretory form of the nucleocapsid of the hepatitis B virus (HBV), which is a marker of viral replication. In this study, a novel signal amplification system (SAS) based on the lateral flow immunoassay (LFIA) was used for rapid detection of HBeAg in blood samples from patients or blood donors. In this assay, the detection antibody was conjugated with gold nanoparticles (GNPs), and the capture antibody was labeled with biotin. The presence of targeting antigen HBeAg in blood sample would act as a bridge with biotinylated captured antibody and GNP-conjugated detection antibody to form the dendritic nanoparticle complex. The dendritic complexes in the sample solution were migrated and immobilized on the testing line of strip coated with antibiotin antibodies. Signal intensity was massively amplified by the SAS, which was positively correlated with the concentration of targeting antigen in the blood sample and was assessed by eyes or strip scanner. The SAS worked only when targeting antigens were present in the sample. By using this SAS-LFIA, we were able to detect a very low concentration of HBeAg (9 ng/mL), which was 27-fold sensitive than that by conventional LFIA (cLFIA). A number of 420 blood samples were detested by this novel SAS-LFIA, the results were in accordance with those of enzymelinked immunosorbent assay (ELISA) completely, while the cLFIA missed an HBeAgpositive sample. In conclusion, the novel SAS has high specificity and sensitivity, which can be used to replace the conventional rapid test and ELISA in clinical diagnosis. K E Y W O R D S detection, hepatitis B e-antigen, lateral flow immunoassay, sensitivity and specificity, signal amplification system

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Evaluation of a New Hepatitis B Virus Surface Antigen Rapid Test with Improved Sensitivity

Cited by 52 publications

References 14 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

Cloning of anti-HBsAg single-chain variable fragments from hybridoma cells for one-step ELISA

A signal amplification system on a lateral flow immunoassay detecting for hepatitis e‐antigen in human blood samples

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