Sensitivity of five rapid HIV tests on oral fluid or Finger-Stick whole blood: A real-time comparison in a healthcare setting

PLoS ONE

Volumn 5, Issue 7, 2010, Pages

  Pavie, Juliette ^a   Rachline, Anne ^a   Loze, Bénédicte ^a   Niedbalski, Laurence ^a   Delaugerre, Constance ^a   Laforgerie, Eric ^b   Plantier, Jean Christophe ^c   Rozenbaum, Willy ^a   Chevret, Sylvie ^a   Molina, Jean Michel ^a   Simon, François ^a  

^a SAINT LOUIS HOSPITAL   (France)

^b division surveillance   (France)

^c HÔPITAL CHARLES NICOLLE   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; VIRUS RNA; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY;

ADULT; ARTICLE; BLOOD ANALYSIS; BLOOD SAMPLING; BODY FLUID; CONTROLLED STUDY; ENZYME IMMUNOASSAY; FALSE NEGATIVE RESULT; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS 2 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; ORAL FLUID; SCREENING TEST; SENSITIVITY AND SPECIFICITY; SERODIAGNOSIS; SERUM; VIRUS LOAD; ADOLESCENT; BLOOD; CHEMISTRY; EUROPE; FINGER; METHODOLOGY; MIDDLE AGED; SALIVA; VASCULARIZATION;

HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 2;

ADOLESCENT; ADULT; AIDS SERODIAGNOSIS; EUROPE; FEMALE; FINGERS; HIV ANTIBODIES; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; SALIVA; SENSITIVITY AND SPECIFICITY; YOUNG ADULT;

EID: 77955371722     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0011581     Document Type: Article

References (36)

1. Losina E, Schackman BR, Sadownik SN, Gebo KA, Walensky RP, et al. (2009) Racial and Sex Disparities in Life Expectancy Losses among HIV-Infected Persons in the United States: Impact of Risk Behavior, Late Initiation, and Early Discontinuation of Antiretroviral Therapy. Clin Infect Dis 49: 1570-1578.
2. Hamers FF, Phillips AN (2008) Diagnosed and undiagnosed HIV infected populations in Europe. HIV Med 9 (Suppl 2): 6-12.
3. Delpierre C, Cuzin L, Lauwers-Cances V, Marchou B, Lang T, et al. (2006) High-Risk groups for late diagnosis of HIV infection: a need for rethinking testing policy in the general population. AIDS Patient care STDs 20: 838-847.
4. Braitstein P, Brinkhof MW, Dabis F, Schechter M, Boulle A, et al. (2006) Mortality of HIV-1-infected patients in the first year of antiretroviral therapy: comparison between low-income and high-income countries. Lancet 367: 817-824.
5. Kigozi I, Dobkin L, Martin JN, Geng EH, Muyindike W, et al. (2009) Late- Disease Stage at Presentation to an HIV Clinic in the Era of Free Antiretroviral Therapy in Sub-Saharan Africa. J AIDS 52: 280-289.
6. Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, et al. (2006) Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 55 (RR-14): 1-17.
7. Spielberg F, Kabeya CM, Ryder RW (1989) Field testing and comparative evaluation of rapid, visually read screening assays for antibody to human immunodeficiency virus. Lancet 333: 580-584.
8. Makuwa M, Souquière S, Niangui MT, Rouquet P, Apetrei C, et al. (2002) Reliability of rapid diagnostic tests for HIV variant infection. J Virol Methods 103: 183-190.
9. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Commission Decision of 3 February 2009 amending. Available: http://eur-lex.europa.eu/fr/index.htm.
10. Decision 2002/364/EC on common technical specifications for in vitrodiagnostic medical devices. 2009/108/EC.Available: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:131:0017:0030.
11. Conseil national du sida. Rapport sur l'évolution du dispositif de dépistage de l'infection par le VIH en France. Suivi de recommandations, adopté lors de la séance plénière du 16 novembre 2006 sur proposition de la commission "Dépistage". Available: http://www.cns.sante.fr/spip.php?article263.
12. Simon F, Souquière S, Damond F, Kfutwah A, Makuwa M, et al. (2001) Synthetic peptide strategy for the detection of and discrimination among highly divergent primate lentiviruses. AIDS Res Hum Retroviruses 17: 937-952.
13. von Sydow M, Gaines H, Sönnerborg A, Forsgren M, Pehrson PO, et al. (1988) Antigen detection in primary HIV infection. Br Med J 296: 238-240.
14. Eshleman SH, Khaki L, Laeyendecker O, Piwowar-Manning E, Johnson-Lewis L, et al. (2009) Detection of individuals with acute HIV-1 infection using the ARCHITECT HIV Ag/Ab Combo assay. J Acquir Immune Defic Syndr 52: 121-124.
15. Leung DH, Wang YG, Zhu M (2009) Efficient parameter estimation in longitudinal data analysis using a hybrid GEE method. Biostatistics 10: 436-445.
16. Smith W, Solow AR (1996) An Exact Mcnemar Test For Paired Binary Markov Chains. Biometrics 52: 1063-1070.
17. Fiebig EW, Wright DJ, Rawal BD, Garrett PE, Schumacher RT, et al. (2003) Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 17: 1871-1879.
18. Joint United Nations Programme on HIV/AIDS (UNAIDS) - WHO (1997) Revised recommendations for the selection and use of HIV antibody tests. Weekly epidemiological record 72: 81-88.
19. Technical Expert Panel Review of CDC HIV Counseling, Testing, and Referral Guidelines. (2001) Recommendations an Reports Revised Guidelines for HIV Counseling, Testing and Referral. MMWR 50(RR19): 1-58.
20. Delaney KP, Branson BM, Uniyal A, Kerndt PR, Keenan PA, et al. (2006) Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies. AIDS 20: 1655-1660.
21. Scott LE, Noble LD, Langeveldt M, Jentsch U, Francois Venter WD, Stevens W (2009) Can oral fluid testing be used to replace blood-based HIV rapid testing to improve access to diagnosis in South Africa? J Acquir Immune Defic Syndr 51: 646-648.
22. Holguín A, Gutiérrez M, Portocarrero N, Rivas P, Baquero M (2009) Performance of OraQuick Advance Rapid HIV-1/2 Antibody Test for detection of antibodies in oral fluid and serum/plasma in HIV-1+ subjects carrying different HIV-1 subtypes and recombinant variants. J Clin Virol 45: 150-152.
23. Stekler JD, Wood RW, Swenson PD, Golden M (2007) Negative rapid HIV antibody testing during early HIV infection. Ann Intern Med 147: 147-148.
24. Stekler JD, Swenson PD, Coombs RW, Dragavon J, Thomas KK, et al. (2009) HIV testing in a high-incidence population: is antibody testing alone good enough? Clin Infect Dis 49: 444-445.
25. Ly TD, Ebel A, Faucher V, Fihman V, Laperche S (2007) Could the new HIV combined P24 antigen and antibody assays replace P24 antigen specific assays? J Virol Methods; 143: 86-94.
26. Tardy JC (2009) Test Rapide VIH de 4ème génération. Journée Nationale d'InfectiologieLyon. Available: http://www.infectiologie.com/site/medias/JNI/JNI09/VIH/TARDY-depist-JNI09.
27. Laforgerie E, Boucher B, Ly TD, Maisoneuve L, Izopet J, et al. (2010) Sensitivity of 8 CE (European Community)-approved rapid disposable tests for anti-HIV antibody detection during and after seroconversion. J Virol Methods 165: 105-107.
28. Everett DB, Baisley K, Changalucha J, Vallely A, Watson-Jones D, et al. (2009) Suitability of Simple Human Immunodeficiency Virus Rapid Tests in Clinical Trials in Community-Based Clinic Settings. J Clin Microbiol 47: 1058-1062.
29. Schochetman G, George J (1992) Serologic tests for the detection of human immunodeficiency virus infection. In AIDS Testing Methodology and Management Issues, Springer-Verlag, New York.
30. Apetrei C, Loussert-Ajaka I, Descamps D, Damond F, Saragosti S, et al. (1996) Lack of screening test sensitivity during HIV-1 non-subtype B seroconversions. AIDS 10: 57-60.
31. Gautheret-Dejean A, Mesmin-Poho S, Birguel J, Lemée V, Huraux JM, et al. (2008) Unequal detection of HIV type 1 group O infection by simple rapid tests. Clin Infect Dis 46: 1936-1937.
32. Barin F, Cazein F, Lot F, Pillonel J, Brunet S, et al. (2007) Prevalence of HIV-2 and HIV-1 group O infections among new HIV diagnoses in France: 2003-2006. AIDS 21: 2351-53.
33. Wesolowski LG, MacKellar DA, Facente SN, Dowling T, Ethridge SF, et al. (2006) Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing. AIDS 20: 1661-1666.
34. Facente SN, Dowling T, Vittinghoff E, Sykes DL, Colfax GN (2009) False positive rate of rapid oral fluid HIV tests increases as kits near expiration date. PLoS One 4: e8217.
35. Wesolowski LG, Ethridge SF, Martin EG, Cadoff EM, MacKellar DA (2009) Rapid human immunodeficiency virus test quality assurance practices and outcomes among testing sites affiliated with 17 public health departments. J Clin Microbiol 47: 3333-3335.
36. Aghokeng AF, Mpoudi-Ngole E, Dimodi H, Atem-Tambe A, Tongo M, et al. (2009) Inaccurate diagnosis of HIV-1 group M and O is a key challenge for ongoing universal access to antiretroviral treatment and HIV prevention in Cameroon. PLoS One 4: e7702.