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

Journal of Clinical Microbiology

Volumn 53, Issue 4, 2015, Pages 1156-1163

  Njai, Harr Freeya ^a   Shimakawa, Yusuke ^a,b   Sanneh, Bakary ^c   Ferguson, Lynne ^a   Ndow, Gibril ^a   Mendy, Maimuna ^d   Sow, Amina ^e   Lo, Gora ^e   Toure Kane, Coumba ^e   Tanaka, Junko ^b   Taal, Makie ^c   D'Alessandro, Umberto ^a   Njie, Ramou ^a,d   Thursz, Mark ^f   Lemoine, Maud ^a,f  

^a MEDICAL RESEARCH COUNCIL LABORATORIES   (Gambia)

^b HIROSHIMA UNIVERSITY   (Japan)

^c National Health Laboratory   (Gambia)

^d INTERNATIONAL AGENCY FOR RESEARCH ON CANCER   (France)

^e UNIVERSITÉ CHEIKH ANTA DIOP   (Senegal)

^f IMPERIAL COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS B SURFACE ANTIGEN;

ADOLESCENT; ADULT; AFRICA; AGED; ANTIGEN DETECTION; ARTICLE; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DRIED BLOOD SPOT TESTING; ENZYME LINKED IMMUNOSORBENT ASSAY; FALSE NEGATIVE RESULT; FEMALE; HEPATITIS B; HEPATITIS B RAPID TEST; HEPATITIS ELISA KIT; HUMAN; INTERMETHOD COMPARISON; INTERRATER RELIABILITY; MAJOR CLINICAL STUDY; MALE; POINT OF CARE TESTING; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY; VERY ELDERLY; BLOOD; GAMBIA; MIDDLE AGED; POINT OF CARE SYSTEM; PROCEDURES; REPRODUCIBILITY; YOUNG ADULT;

HEPATITIS B VIRUS;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; GAMBIA; HEPATITIS B; HEPATITIS B SURFACE ANTIGENS; HUMANS; MALE; MIDDLE AGED; POINT-OF-CARE SYSTEMS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; YOUNG ADULT;

EID: 84925234033     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.02980-14     Document Type: Article

References (33)

1. Ott JJ, Stevens GA, Groeger J, Wiersma ST. 2012. Global epidemiology of hepatitis B virus infection: new estimates of age-specific HBsAg seroprevalence and endemicity. Vaccine 30:2212-2219. http://dx.doi.org/10.1016/j.vaccine.2011.12.116.
2. Parkin DM, Sitas F, Chirenje M, Stein L, Abratt R, Wabinga H. 2008. Part I: cancer in indigenous Africans - burden, distribution, and trends. Lancet Oncol 9:683-692. http://dx.doi.org/10.1016/S1470-2045(08)70175-X.
3. Jemal A, Bray F, Forman D, O'Brien M, Ferlay J, Center M, Parkin DM. 2012. Cancer burden in Africa and opportunities for prevention. Cancer 118:4372-4384. http://dx.doi.org/10.1002/cncr.27410.
4. Thursz M, Cooke GS, Hall AJ. 2010. Hepatitis B treatment in resource poor settings: time for action. Trop Med Int Health 15:2-4. http://dx.doi.org/10.1111/j.1365-3156.2009.02410.x.
5. Thursz M, Njie R, Lemoine M. 2012. Hepatitis: global eradication of hepatitis B-feasible or fallacy? Nat Rev Gastroenterol Hepatol 9:492-494. http://dx.doi.org/10.1038/nrgastro.2012.155.
6. Shivkumar S, Peeling R, Jafari Y, Joseph L, Pai NP. 2012. Rapid point-of-care first-line screening tests for hepatitis B infection: a meta-analysis of diagnostic accuracy (1980-2010). Am J Gastroenterol 107: 1306-1313. http://dx.doi.org/10.1038/ajg.2012.141.
7. Hwang SH, Oh HB, Choi SE, Kim HH, Chang CL, Lee EY, Son HC. 2008. Meta-analysis for the pooled sensitivity and specificity of hepatitis B surface antigen rapid tests. Korean J Lab Med 28:160-168. http://dx.doi.org/10.3343/kjlm.2008.28.2.160.
8. Mvere D, Constantine NT, Katsawde E, Tobaiwa O, Dambire S, Corcoran P. 1996. Rapid and simple hepatitis assays: encouraging results from a blood donor population in Zimbabwe. Bull World Health Organ 74:19-24.
9. Akanmu AS, Esan OA, Adewuyi JO, Davies AO, Okany CC, Olatunji RO, Babalola T. 2006. Evaluation of a rapid test kit for detection of HBsAg/eAg in whole blood: a possible method for pre-donation testing. Afr J Med Med Sci 35:5-8.
10. Lin YH, Wang Y, Loua A, Day GJ, Qiu Y, Nadala EC, Jr, Allain JP, Lee HH. 2008. Evaluation of a new hepatitis B virus surface antigen rapid test with improved sensitivity. J Clin Microbiol 46:3319-3324. http://dx.doi.org/10.1128/JCM.00498-08.
11. Shibahara K, Sugada F, Okuse C, Yasuda K, Lino S. 1997. Fundamental evaluation of HBs antigen and HBs antibody rapid test by immunochromatography assay. Jpn J Med Pharm Sci 38:343-350.
12. Lien TX, Tien NT, Chanpong GF, Cuc CT, Yen VT, Soderquist R, Laras K, Corwin A. 2000. Evaluation of rapid diagnostic tests for the detection of human immunodeficiency virus types 1 and 2, hepatitis B surface antigen, and syphilis in Ho Chi Minh City, Vietnam. Am J Trop Med Hyg 62:301-309.
13. Nyirenda M, Beadsworth MB, Stephany P, Hart CA, Hart IJ, Munthali C, Beeching NJ, Zijlstra EE. 2008. Prevalence of infection with hepatitis B and C virus and coinfection with HIV in medical inpatients in Malawi. J Infect 57:72-77. http://dx.doi.org/10.1016/j.jinf.2008.05.004.
14. Davies J, van Oosterhout JJ, Nyirenda M, Bowden J, Moore E, Hart IJ, Zijlstra EE, Chaponda M, Faragher B, Beeching NJ, Beadsworth MB. 2010. Reliability of rapid testing for hepatitis B in a region of high HIV endemicity. Trans R Soc Trop Med Hyg 104:162-164. http://dx.doi.org/10.1016/j.trstmh.2009.10.010.
15. Geretti AM, Patel M, Sarfo FS, Chadwick D, Verheyen J, Fraune M, Garcia A, Phillips RO. 2010. Detection of highly prevalent hepatitis B virus coinfection among HIV-seropositive persons in Ghana. J Clin Microbiol 48:3223-3230. http://dx.doi.org/10.1128/JCM.02231-09.
16. Hoffmann CJ, Dayal D, Cheyip M, McIntyre JA, Gray GE, Conway S, Martinson NA. 2012. Prevalence and associations with hepatitis B and hepatitis C infection among HIV-infected adults in South Africa. Int J STD AIDS 23:e10-e13. http://dx.doi.org/10.1258/ijsa.2009.009340.
17. Franzeck FC, Ngwale R, Msongole B, Hamisi M, Abdul O, Henning L, Letang E, Mwaigomole G, Battegay M, Hatz C, Tanner M. 2013. Viral hepatitis and rapid diagnostic test based screening for HBsAg in HIV-infected patients in rural Tanzania. PLoS One 8:e58468. http://dx.doi.org/10.1371/journal.pone.0058468.
18. Honge B, Jespersen S, Medina C, Te D, da Silva Z, Ostergaard L, Laursen A, Wejse C, Krarup H, Erikstrup C. 2014. Hepatitis B virus surface antigen and anti-hepatitis C virus rapid tests underestimate hepatitis prevalence among HIV-infected patients. HIV Med 15:571-576. http://dx.doi.org/10.1111/hiv.12158.
19. Bottero J, Boyd A, Gozlan J, Lemoine M, Carrat F, Collignon A, Boo N, Dhotte P, Varsat B, Muller G, Cha O, Picard O, Nau J, Campa P, Silbermann B, Bary M, Girard PM, Lacombe K. 2013. Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France. J Hepatol 58:473-478. http://dx.doi.org/10.1016/j.jhep.2012.11.016.
20. Whittle HC, Bradley AK, McLauchlan K, Ajdukiewicz AB, Howard CR, Zuckerman AJ, McGregor IA. 1983. Hepatitis B virus infection in two Gambian villages. Lancet i:1203-1206.
21. Whittle H, Inskip H, Bradley AK, McLaughlan K, Shenton F, Lamb W, Eccles J, Baker BA, Hall AJ. 1990. The pattern of childhood hepatitis B infection in two Gambian villages. J Infect Dis 161:1112-1115. http://dx.doi.org/10.1093/infdis/161.6.1112.
22. Castera L, Forns X, Alberti A. 2008. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol 48:835-847. http://dx.doi.org/10.1016/j.jhep.2008.02.008.
23. Lemoine M, Shimakawa Y, Njie R, Njai HF, Nayagam S, Khalil M, Goldin R, Ingiliz P, Taal M, Nyan O, Corrah T, D'Alessandro U, Thursz M. 2014. Food intake increases liver stiffness measurements and hampers reliable values in patients with chronic hepatitis B and healthy controls: the PROLIFICA experience in the Gambia. Aliment Pharmacol Ther 39: 188-196. http://dx.doi.org/10.1111/apt.12561.
24. Marcellin P, Ziol M, Bedossa P, Douvin C, Poupon R, de Ledinghen V, Beaugrand M. 2009. Non-invasive assessment of liver fibrosis by stiffness measurement in patients with chronic hepatitis B. Liver Int 29:242-247. http://dx.doi.org/10.1111/j.1478-3231.2008.01802.x.
25. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC. 2003. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Ann Intern Med 138:40-44. http://dx.doi.org/10.7326/0003-4819-138-1-200301070-00010.
26. Papatheodoridis G, Buti M, Cornberg M, Janssen HL, Mutimer D, Pol S, Raimondo G, Dusheiko G, Lok A, Marcellin P, European Association for the Study of the Liver. 2012. EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J Hepatol 57:167-185. http://dx.doi.org/10.1016/j.jhep.2012.02.010.
27. Scheiblauer H, El-Nageh M, Diaz S, Nick S, Zeichhardt H, Grunert HP, Prince A. 2010. Performance evaluation of 70 hepatitis B virus (HBV) surface antigen (HBsAg) assays from around the world by a geographically diverse panel with an array of HBV genotypes and HBsAg subtypes. Vox Sang 98: 403-414. http://dx.doi.org/10.1111/j.1423-0410.2009.01272.x.
28. Farghaly AM, Mohsen A, Omar ME, Khalil MA, Gaber MA. 1990. Synthesis of 3-aryl-2-substituted-4(3H)-quinazolines as potential antimicrobial agents. Farmaco 45:431-438.
29. Villar LM, de Oliveira JC, Cruz HM, Yoshida CF, Lampe E, Lewis-Ximenez LL. 2011. Assessment of dried blood spot samples as a simple method for detection of hepatitis B virus markers. J Med Virol 83:1522-1529. http://dx.doi.org/10.1002/jmv.22138.
30. Kania D, Bekale AM, Nagot N, Mondain AM, Ottomani L, Meda N, Traore M, Ouedraogo JB, Ducos J, Van de Perre P, Tuaillon E. 2013. Combining rapid diagnostic tests and dried blood spot assays for point-of-care testing of human immunodeficiency virus, hepatitis B and hepatitis C infections in Burkina Faso, West Africa. Clin Microbiol Infect 19: E533-E541. http://dx.doi.org/10.1111/1469-0691.12292.
31. World Health Organization. 2014. Call to action to scale up global hepatitis response. World Health Organization, Geneva, Switzerland. http://www.who.int/hiv/mediacentre/news/hep-calltoaction2014/en/.
32. th Intersci Conf Antimicrob Agents Chemother, 26 to 29 September 1999. American Society for Microbiology, Washington, DC.
33. Randrianirina F, Carod JF, Ratsima E, Chretien JB, Richard V, Talarmin A. 2008. Evaluation of the performance of four rapid tests for detection of hepatitis B surface antigen in Antananarivo, Madagascar. J Virol Methods 151:294-297. http://dx.doi.org/10.1016/j.jviromet.2008.03.019.