title: 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.
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.
authors: Medical Research Council Unit, the Gambia, Banjul, the Gambia.
authors: Harr Freeya
authors: HF
authors: Njai
authors: Medical Research Council Unit, the Gambia, Banjul, the Gambia Department of Epidemiology/Infectious Disease Control and Prevention, Hiroshima University, Hiroshima, Japan.
authors: Yusuke
authors: Y
authors: Shimakawa
authors: National Public Health Laboratory, Banjul, the Gambia.
authors: Bakary
authors: B
authors: Sanneh
authors: Medical Research Council Unit, the Gambia, Banjul, the Gambia.
authors: Lynne
authors: L
authors: Ferguson
authors: Medical Research Council Unit, the Gambia, Banjul, the Gambia.
authors: Gibril
authors: G
authors: Ndow
authors: Laboratory Services and Biobank Group, International Agency for Research on Cancer, Lyon, France.
authors: Maimuna
authors: M
authors: Mendy
authors: Laboratoire de Bacteriologie Virologie, Université Cheikh Anta Diop, CHU Le Dantec, Dakar, Senegal.
authors: Amina
authors: A
authors: Sow
authors: Laboratoire de Bacteriologie Virologie, Université Cheikh Anta Diop, CHU Le Dantec, Dakar, Senegal.
authors: Gora
authors: G
authors: Lo
authors: Laboratoire de Bacteriologie Virologie, Université Cheikh Anta Diop, CHU Le Dantec, Dakar, Senegal.
authors: Coumba
authors: C
authors: Toure-Kane
authors: Department of Epidemiology/Infectious Disease Control and Prevention, Hiroshima University, Hiroshima, Japan.
authors: Junko
authors: J
authors: Tanaka
authors: National Public Health Laboratory, Banjul, the Gambia.
authors: Makie
authors: M
authors: Taal
authors: Medical Research Council Unit, the Gambia, Banjul, the Gambia.
authors: Umberto
authors: U
authors: D'alessandro
authors: Medical Research Council Unit, the Gambia, Banjul, the Gambia Laboratory Services and Biobank Group, International Agency for Research on Cancer, Lyon, France.
authors: Ramou
authors: R
authors: Njie
authors: Department of Hepatology, Division of Medicine, Imperial College, London, United Kingdom.
authors: Mark
authors: M
authors: Thursz
authors: 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.
authors: Maud
authors: M
authors: Lemoine
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D005714:Gambia; D006509:Hepatitis B / Q000175:diagnosis*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D006514:Hepatitis B Surface Antigens
references: Bull World Health Organ. 1996;74(1):19-24
references: 8653812
references: Lancet. 1983 May 28;1(8335):1203-6
references: 6133999
references: Lancet Oncol. 2008 Jul;9(7):683-92
references: 18598933
references: Nat Rev Gastroenterol Hepatol. 2012 Sep;9(9):492-4
references: 22868658
references: Clin Microbiol Infect. 2013 Dec;19(12):E533-41
references: 23902574
references: Am J Trop Med Hyg. 2000 Feb;62(2):301-9
references: 10813489
references: Liver Int. 2009 Feb;29(2):242-7
references: 18637064
references: Int J STD AIDS. 2012 Oct;23(10):e10-3
references: 23104758
references: J Clin Microbiol. 2010 Sep;48(9):3223-30
references: 20631103
references: Am J Gastroenterol. 2012 Sep;107(9):1306-13
references: 22641308
references: Trop Med Int Health. 2010 Jan;15(1):2-4
references: 19843297
references: Vox Sang. 2010 Apr;98(3 Pt 2):403-14
references: 20412171
references: Cancer. 2012 Sep 15;118(18):4372-84
references: 22252462
references: J Hepatol. 2013 Mar;58(3):473-8
references: 23183527
references: PLoS One. 2013;8(3):e58468
references: 23469281
references: J Clin Microbiol. 2008 Oct;46(10):3319-24
references: 18701669
references: J Infect. 2008 Jul;57(1):72-7
references: 18555534
references: Aliment Pharmacol Ther. 2014 Jan;39(2):188-96
references: 24308698
references: Ann Intern Med. 2003 Jan 7;138(1):40-4
references: 12513043
references: J Hepatol. 2008 May;48(5):835-47
references: 18334275
references: Vaccine. 2012 Mar 9;30(12):2212-9
references: 22273662
references: J Med Virol. 2011 Sep;83(9):1522-9
references: 21739441
references: J Virol Methods. 2008 Aug;151(2):294-297
references: 18462816
references: HIV Med. 2014 Oct;15(9):571-6
references: 24717010
references: Afr J Med Med Sci. 2006 Mar;35(1):5-8
references: 17209320
references: J Infect Dis. 1990 Jun;161(6):1112-5
references: 2345294
references: Korean J Lab Med. 2008 Apr;28(2):160-8
references: 18458514
references: Trans R Soc Trop Med Hyg. 2010 Feb;104(2):162-4
references: 19931107
references: J Hepatol. 2012 Jul;57(1):167-85
references: 22436845
references: Farmaco. 1990 Apr;45(4):431-8
references: 2119178