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J Clin Microbiol. 2015 Apr;53(4):1156-63. doi: 10.1128/JCM.02980-14. Epub 2015 Jan 28.

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.

Author information

1
Medical Research Council Unit, the Gambia, Banjul, the Gambia.
2
Medical Research Council Unit, the Gambia, Banjul, the Gambia Department of Epidemiology/Infectious Disease Control and Prevention, Hiroshima University, Hiroshima, Japan.
3
National Public Health Laboratory, Banjul, the Gambia.
4
Laboratory Services and Biobank Group, International Agency for Research on Cancer, Lyon, France.
5
Laboratoire de Bacteriologie Virologie, Université Cheikh Anta Diop, CHU Le Dantec, Dakar, Senegal.
6
Department of Epidemiology/Infectious Disease Control and Prevention, Hiroshima University, Hiroshima, Japan.
7
Medical Research Council Unit, the Gambia, Banjul, the Gambia Laboratory Services and Biobank Group, International Agency for Research on Cancer, Lyon, France.
8
Department of Hepatology, Division of Medicine, Imperial College, London, United Kingdom.
9
Medical Research Council Unit, the Gambia, Banjul, the Gambia Department of Hepatology, Division of Medicine, Imperial College, London, United Kingdom m.lemoine@imperial.ac.uk.

Abstract

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.

PMID:
25631805
PMCID:
PMC4365211
DOI:
10.1128/JCM.02980-14
[Indexed for MEDLINE]
Free PMC Article

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