Evaluation of Four Rapid Tests for Detection of Hepatitis B Surface Antigen in Ivory Coast.
Algorithms
Antibodies, Viral
/ blood
Cote d'Ivoire
Cross-Sectional Studies
False Negative Reactions
Hepatitis B
/ diagnosis
Hepatitis B Surface Antigens
/ immunology
Hepatitis B virus
/ physiology
Humans
Mass Screening
Predictive Value of Tests
Reference Standards
Reproducibility of Results
Sensitivity and Specificity
Serologic Tests
/ methods
Journal
Journal of immunology research
ISSN: 2314-7156
Titre abrégé: J Immunol Res
Pays: Egypt
ID NLM: 101627166
Informations de publication
Date de publication:
2020
2020
Historique:
received:
19
02
2020
revised:
04
05
2020
accepted:
11
06
2020
entrez:
18
7
2020
pubmed:
18
7
2020
medline:
22
5
2021
Statut:
epublish
Résumé
Hepatitis B virus (HBV) infection is a leading cause of liver disease worldwide. Hepatitis B surface antigen (HBsAg) rapid diagnostic tests (RDTs) could be an ideal tool for a large-scale HBV screening in settings with high endemicity but limited infrastructure. The aim of this study was to evaluate the diagnosis performance of such RDTs for screening HBV infection in Ivory Coast. From September 2018 to January 2019, a cross-sectional phase I evaluation study of RDTs was conducted in three laboratories of Abidjan (CeDReS, CNTS and IPCI), on a panel of 405 whole blood samples and 699 plasmas. Four HBsAg RDTs (Determine™ HBsAg, SD Bioline HBsAg WB®, Standard Q HBsAg® and Vikia HBsAg®) were evaluated. The diagnostic performance (sensitivity and specificity) was calculated in comparison to the reference sequential algorithms of two EIA tests (Dia.Pro HBsAg® one version ULTRA and Monolisa™ HBsAg ULTRA). The Determine™ HBsAg and Vikia HBsAg® tests performed well, with 100% of sensitivity, specificity both on plasma and on whole blood. For SD Bioline HBsAg WB® and Standard Q HBsAg®, the specificities were 99.8% and the sensitivities 99.3% and 97.1% respectively. Finally, there were a total of 19 false negative results: 3 with SD Bioline HBsAg WB® and 16 with Standard Q HBsAg®. Determine HBsAg® from Alere and Vikia HBsAg® from Biomérieux are the most suitable RDTs for screening for HBV in Ivory Coast. A phase II evaluation must be initiated.
Sections du résumé
BACKGROUND
BACKGROUND
Hepatitis B virus (HBV) infection is a leading cause of liver disease worldwide. Hepatitis B surface antigen (HBsAg) rapid diagnostic tests (RDTs) could be an ideal tool for a large-scale HBV screening in settings with high endemicity but limited infrastructure. The aim of this study was to evaluate the diagnosis performance of such RDTs for screening HBV infection in Ivory Coast.
METHODS
METHODS
From September 2018 to January 2019, a cross-sectional phase I evaluation study of RDTs was conducted in three laboratories of Abidjan (CeDReS, CNTS and IPCI), on a panel of 405 whole blood samples and 699 plasmas. Four HBsAg RDTs (Determine™ HBsAg, SD Bioline HBsAg WB®, Standard Q HBsAg® and Vikia HBsAg®) were evaluated. The diagnostic performance (sensitivity and specificity) was calculated in comparison to the reference sequential algorithms of two EIA tests (Dia.Pro HBsAg® one version ULTRA and Monolisa™ HBsAg ULTRA).
RESULTS
RESULTS
The Determine™ HBsAg and Vikia HBsAg® tests performed well, with 100% of sensitivity, specificity both on plasma and on whole blood. For SD Bioline HBsAg WB® and Standard Q HBsAg®, the specificities were 99.8% and the sensitivities 99.3% and 97.1% respectively. Finally, there were a total of 19 false negative results: 3 with SD Bioline HBsAg WB® and 16 with Standard Q HBsAg®.
CONCLUSION
CONCLUSIONS
Determine HBsAg® from Alere and Vikia HBsAg® from Biomérieux are the most suitable RDTs for screening for HBV in Ivory Coast. A phase II evaluation must be initiated.
Identifiants
pubmed: 32676509
doi: 10.1155/2020/6315718
pmc: PMC7335398
doi:
Substances chimiques
Antibodies, Viral
0
Hepatitis B Surface Antigens
0
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
6315718Informations de copyright
Copyright © 2020 Bamory Dembele et al.
Déclaration de conflit d'intérêts
The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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