Assessment of oral fluid HIV test performance in an HIV pre-exposure prophylaxis trial in Bangkok, Thailand

PLoS ONE

Volumn 10, Issue 12, 2015, Pages

  Suntharasamai, Pravan ^a   Martin, Michael ^b,c   Choopanya, Kachit ^a   Vanichseni, Suphak ^a   Sangkum, Udomsak ^a   Tararut, Pairote ^b   Leelawiwat, Wanna ^b   Anekvorapong, Rapeepan ^d   Mock, Philip A ^b   Cherdtrakulkiat, Thitima ^b   Leethochawalit, Manoj ^d   Chiamwongpaet, Sithisat ^d   Gvetadze, Roman J ^c   McNicholl, Janet M ^c   Paxton, Lynn A ^c   Kittimunkong, Somyot ^b   Curlin, Marcel E ^b,c  

^a Bangkok Tenofovir Study Group   (Thailand)

^b MINISTRY OF PUBLIC HEALTH   (Thailand)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d Bangkok Metropolitan Administration   (Thailand)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TENOFOVIR DISOPROXIL; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; DIAGNOSTIC KIT; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; TENOFOVIR;

ADULT; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; DISEASE TRANSMISSION; DOUBLE BLIND PROCEDURE; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HIV RAPID TEST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTRAVENOUS DRUG ABUSE; MALE; NUCLEIC ACID AMPLIFICATION; PRE-EXPOSURE PROPHYLAXIS; PREDICTIVE VALUE; RANDOMIZED CONTROLLED TRIAL; SCREENING TEST; SENSITIVITY AND SPECIFICITY; SEQUENCE ANALYSIS; THAILAND; WESTERN BLOTTING; BLOOD; CLINICAL TRIAL; DIAGNOSTIC KIT; ENZYME IMMUNOASSAY; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 2; IMMUNOLOGY; MASS SCREENING; MIDDLE AGED; PROCEDURES; REPRODUCIBILITY; STANDARDS; VIROLOGY; YOUNG ADULT;

ADULT; ANTI-HIV AGENTS; FEMALE; HIV ANTIBODIES; HIV INFECTIONS; HIV-1; HIV-2; HUMANS; IMMUNOENZYME TECHNIQUES; MALE; MASS SCREENING; MIDDLE AGED; PRE-EXPOSURE PROPHYLAXIS; REAGENT KITS, DIAGNOSTIC; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TENOFOVIR; THAILAND; YOUNG ADULT;

EID: 84957093361     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0145859     Document Type: Article

References (23)

1. World Health Organization. Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Geneva 2013. Available: http://www.who.int/hiv/pub/guidelines/arv2013/en/. Accessed 27 May 2015
2. CDC. Advancing HIV prevention: new strategies for a changing epidemic-United States, 2003. MMWR Morb Mortal Wkly Rep. 2003; 52: 329-332. PMID: 12733863
3. UNAIDS. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. Geneva 2014. Available http://www.unaids.org/en/resources/documents/2014/90-90-90. Accessed 27 May 2015
4. World Health Organization. Service delivery approaches to HIV testing and counselling (HCT): a strategic HTC programme framework. Geneva 2012. Available: http://apps.who.int/iris/bitstream/10665/75206/1/9789241593877-eng.pdf. Accessed 27 May 2015.
5. Branson BM. State of the art for diagnosis of HIV infection. Clin Infect Dis. 2007; 45 Suppl 4: S221-225. doi: 10.1086/522541 PMID: 18190290
6. Food and Drug Administration. OraQuick1In-Home HIV Test Summary of Safety and Effectiveness. 2012. Available: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM312534.pdf. Accessed 27 May 2015.
7. Thailand Food and Drug Administration. Medical Device Control in Thailand. 1990. Available: http://www.fda.moph.go.th/fda-net/html/product/mdcd/eng/attach01-1.asp. Accessed 27 May 2015.
8. Thailand Ministry of Public Health, Department of Medical Sciences. Diagnositic HIV tests available in Thailand. 2014. Available: http://ttp.dmsc.moph.go.th/ttp/th/file/file2download/2557/kit-evaluation/TEST%20KIT%20update%20(2014%20May%2012).pdf. Accessed 27 May 2015.
9. Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013; 381: 2083-2090. doi: 10.1016/S0140-6736(13)61127-7 PMID: 23769234
10. OraSure Technologies. OraQuick Advance Rapid HIV-1/2 Antibody Test [package insert]. 2004. Available: http://www.fda.gov/downloads/BiologicsBloodVaccines/ucm091917.pdf. Accessed 27 May 2015.
11. Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Chuachoowong R, Mock PA, et al. Enrollment characteristics and risk behaviors of injection drug users participating in the Bangkok Tenofovir Study, Thailand. PLOS ONE. 2011; 6(9): e25127. doi: 10.1371/journal.pone.0025127 PMID: 21969870
12. OraSure Technologies. OraQuick Rapid HIV-1/2 Antibody Test 2001. Available: http://www.pathwaybiomed.com/pdf/204-7052%20%28rev.%206-01%29%20%202%20PI%20Outside%20USA %20Quoc%2020060608.pdf. Accessed 27 May 2015.
13. Armitage PBG, Matthews JNS. Statistical Methods in Medical Research. 4th Edition. New York: Blackwell Science; 2001.
14. van Elteren PH. On the combination of independent two-sample tests of Wilcoxon. Bulletin of the International Statistical Institute.1960; 37: 351-361.
15. Wesolowski LG, MacKellar DA, Facente SN, Dowling T, Ethridge SF, Zhu JH, et al. Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing. AIDS. 2006; 20: 1661-1666. PMID: 16868448
16. Delaney KP, Branson BM, Uniyal A, Kerndt PR, Keenan PA, Jafa K, et al. Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies. AIDS. 2006; 20: 1655-1660. PMID: 16868447
17. O'Connell RJ, Merritt TM, Malia JA, VanCott TC, Dolan MJ, Zahwa H, et al. Performance of the OraQuick rapid antibody test for diagnosis of human immunodeficiency virus type 1 infection in patients with various levels of exposure to highly active antiretroviral therapy. J ClinMicrobiol. 2003; 41: 2153-2155. PMID: 12734265
18. Hu DJ, Vanichseni S, Mastro TD, Raktham S, Young NL, Mock PA, et al. Viral load differences in early infection with two HIV-1 subtypes. AIDS. 2001; 15: 683-691. PMID: 11371682
19. Thailand Ministry of Public Health, Department of Disease Control. Guideline on HIV Counseling and Testing for Same Day Result. Nonthaburi 2013.
20. Patel P, Bennett B, Sullivan T, Parker MM, Heffelfinger JD, Sullivan PS. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. J Clin Virol. 2012; 54: 42-47. doi: 10.1016/j.jcv.2012. 01.022 PMID: 22381919
21. Pilcher CD, Louie B, Facente S, Keating S, Hackett J, Vallari A, et al. Performance of rapid point-ofcare and laboratory tests for acute and established HIV infection in San Francisco. PLoS One. 2013; 8(12): e80629. doi: 10.1371/journal.pone.0080629 PMID: 24349007
22. Pavie J, Rachline A, Loze B, Niedbalski L, Delaugerre C, Laforgerie E, et al. Sensitivity of five rapid HIV tests on oral fluid or finger-stick whole blood: a real-time comparison in a healthcare setting. PLoS One. 2010; 5(7): e11581. doi: 10.1371/journal.pone.0011581 PMID: 20657834
23. Owen SM, Yang C, Spira T, Ou CY, Pau CP, Parekh BS, et al. Alternative algorithms for human immunodeficiency virus infection diagnosis using tests that are licensed in the United States. J Clin Microbiol. 2008; 46: 1588-1595. doi: 10.1128/JCM.02196-07 PMID: 18322061