Evaluation of a rapid point of care test for detecting acute and established HIV infection, and examining the role of study quality on diagnostic accuracy: A Bayesian meta-analysis

PLoS ONE

Volumn 11, Issue 2, 2016, Pages

  Smallwood, Megan ^a   Vijh, Rohit ^b   Nauche, Bénédicte ^c   Lebouché, Bertrand ^a,b   Joseph, Lawrence ^a,b   Pai, Nitika Pant ^a,b  

^a MCGILL UNIVERSITY   (Canada)

^b MCGILL UNIVERSITY HEALTH CENTRE   (Canada)

^c McGill University Health Centre   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN P24; VIRUS RNA;

ANTIBODY DETECTION; ANTIBODY SPECIFICITY; ANTIGEN DETECTION; ANTIGEN SPECIFICITY; ARTICLE; BAYES THEOREM; BLOOD SAMPLING; CASE CONTROL STUDY; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; HIV RAPID TEST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; META ANALYSIS; PERFORMANCE MEASUREMENT SYSTEM; POINT OF CARE TESTING; SENSITIVITY AND SPECIFICITY; EVALUATION STUDY; HEALTH CARE QUALITY; HIV INFECTIONS; HIV SEROPOSITIVITY; SERODIAGNOSIS;

BAYES THEOREM; HIV INFECTIONS; HIV SERONEGATIVITY; HIV SEROPOSITIVITY; HUMANS; POINT-OF-CARE TESTING; QUALITY ASSURANCE, HEALTH CARE; SENSITIVITY AND SPECIFICITY;

EID: 84960851120     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0149592     Document Type: Article

References (50)

1. UNAIDS. AIDS by the numbers 2015. Geneva 2015.
2. WHO. Global summary of the AIDS epidemic 2013. [Table] Geneva: World Health Organization HIV/ AIDS department; 2014 [cited 2014 August 9]; Available from: http://www.who.int/hiv/data/epi-core- dec2014.png?ua=1.
3. Brenner Bluma G, Roger M, Routy JP, Moisi D, Ntemgwa M, Matte C, et al. High Rates of Forward Transmission Events after Acute/Early HIV-1 Infection. J Infect Dis. 2007; 195(7):951-9. PMID: 17330784
4. Hollingsworth TD, Anderson Roy M, Fraser C. HIV-1 Transmission, by Stage of Infection. J Infect Dis. 2008; 198(5):687-93. doi: 10.1086/590501 PMID: 18662132
5. Wawer MJ, Gray RH, Sewankambo NK, Serwadda D, Li X, Laeyendecker O, et al. Rates of HIV-1 transmission per coital act, by stage of HIV-1 infection, in Rakai, Uganda. J Infect Dis. 2005 May 1; 191 (9):1403-9. PMID: 15809897
6. Branson BM. The Future of HIV Testing. J Acquir Immune Defic Syndr. 2010; 55:S102-S5. doi: 10.1097/QAI.0b013e3181fbca44 PMID: 21406978
7. Prabhu VS, Hutchinson AB, Farnham PG, Sansom SL. Sexually acquired HIV infections in the United States due to acute-phase HIV transmission: an update. AIDS. 2009 Aug 24; 23(13):1792-4. doi: 10.1097/QAD.0b013e32832e7d04 PMID: 19684485
8. Dombrowski JC, Harrington RD, Golden MR. Evidence for the Long-Term Stability of HIV Transmission-Associated Sexual Behavior After HIV Diagnosis. Sex Transm Dis. 2013; 40(1):41-5. doi: 10.1097/OLQ.0b013e3182753327 PMID: 23254116
9. Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS. 2006 Jun 26; 20(10):1447-50. PMID: 16791020
10. Bell Sigall K, Little Susan J, Rosenberg Eric S. Clinical Management of Acute HIV Infection: Best Practice Remains Unknown. J Infect Dis. 2010; 202(S2):S278-S88.
11. Wood E, Kerr T, Rowell G, Montaner JSG, Phillips P, Korthuis PT, et al. Does This Adult Patient Have Early HIV Infection? JAMA. 2014; 312(3):278. doi: 10.1001/jama.2014.5954 PMID: 25027143
12. O'Brien M, Markowitz M. Should We Treat Acute HIV Infection? Curr HIV/AIDS Rep. 2012; 9(2):101-10. doi: 10.1007/s11904-012-0113-0 PMID: 22415472
13. Thomas G. WHO issues new HIV recommendations calling for earlier treatment. World Health Organization; 2013 [cited 2014 May 30]; Available from: http://www.who.int/mediacentre/news/releases/2013/ new-hiv-recommendations-20130630/en/.
14. Yang M, Prestage G, Maycock B, Brown G, Wit Jd, McKechnie M, et al. The acceptability of different HIV testing approaches: cross-sectional study among GMSM in Australia. Sex Transm Infect. 2014; 0:1-4.
15. Piwowar-Manning EM, Tustin NB, Sikateyo P, Kamwendo D, Chipungu C, Maharaj R, et al. Validation of Rapid HIV Antibody Tests in 5 African Countries. J Int Assoc Provid AIDS Care. 2010; 9(3):170-2.
16. Burns F, Edwards SG, Woods J, Haidari G, Calderon Y, Leider J, et al. Acceptability, feasibility and costs of universal offer of rapid point of care testing for HIV in an acute admissions unit: results of the RAPID project. HIV Med. 2013 Oct; 14 Suppl 3:10-4. doi: 10.1111/hiv.12056 PMID: 24033896
17. Lewis NM, Gahagan JC, Stein C. Preferences for rapid point-of-care HIV testing in Nova Scotia, Canada. Sex Health. 2013 May; 10(2):124-32. doi: 10.1071/SH12100 PMID: 23369262
18. Appiah LT, Havers F, Gibson J, Kay M, Sarfo F, Chadwick D. Efficacy and acceptability of rapid, pointof-care HIV testing in two clinical settings in Ghana. AIDS Patient Care STDS. 2009 May; 23(5):365-9. doi: 10.1089/apc.2008.0224 PMID: 19323606
19. Branson BM. Point-of-Care Rapid Tests for HIV Antibodies. Laboratoriums Medizin. 2003; 27(7-8):288-95.
20. Stekler Joanne D, Swenson Paul D, Coombs Robert W, Dragavon J, Thomas Katherine K, Brennan Catherine A, et al. HIV Testing in a High-Incidence Population: Is Antibody Testing Alone Good Enough? Clin Infect Dis. 2009; 49(3):444-53. doi: 10.1086/600043 PMID: 19538088
21. Yerly S, Hirschel B. Diagnosing acute HIV infection. Expert Rev Anti Infect Ther. 2012 Jan; 10 (1):31-41.
22. United Nations. The Millennium Development Goals Report: United Nations 2014.
23. Delaney KP, Branson BM, Uniyal A, Phillips S, Candal D, Owen SM, et al. Evaluation of the performance characteristics of 6 rapid HIV antibody tests. Clin Infect Dis. 2011 Jan 15; 52(2):257-63. doi: 10.1093/cid/ciq068 PMID: 21288853
24. Branson BM, Stekler JD. Detection of Acute HIV Infection: We Can't Close the Window. J Infect Dis. 2011; 205(4):521-4. doi: 10.1093/infdis/jir793 PMID: 22207652
25. Branson BM, Owen SM, Wesolowski LG, Bennett B, Werner BG, Wroblewski KE, et al. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. Atlanta, GA: Centers for Disease Control and Prevention; 2014 [September 2 2014]; Available from: http://www.cdc.gov/hiv/pdf/ HIVtestingAlgorithmRecommendation-Final.pdf.
26. Epstein JS. August 9, 2013 Approval Letter - Alere Determine HIV-1/2 Ag/Ab Combo. Silver Spring, MD: U.S. Food and Drug Administration; 2013 [September 2, 2014]; Available from: http://www.fda. gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ ucm364653.htm.
27. Alere International Limited. Alere Determine™HIV-1/2 Ag/Ab Combo. 2014 [August 10 2014]; Available from: http://alerehiv.com/hiv-screening/features.
28. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and metaanalyses: the PRISMA statement. PLoS Med. 2009 Jul 21; 6(7):e1000097. doi: 10.1371/journal.pmed. 1000097 PMID: 19621072
29. Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011 Oct 18; 155 (8):529-36. doi: 10.7326/0003-4819-155-8-201110180-00009 PMID: 22007046
30. Beelaert G, Fransen K. Evaluation of a rapid and simple fourth-generation HIV screening assay for qualitative detection of HIV p24 antigen and/or antibodies to HIV-1 and HIV-2. J Virol Methods. 2010; 168(1-2):218-22. doi: 10.1016/j.jviromet.2010.06.002 PMID: 20561542
31. Bhowan K, Kalk E, Khan S, Sherman G. Identifying HIV infection in South African women, How does a fourth generation HIV rapid test perform? Afr J Lab Med. 2011; 1(1).
32. Brauer M, De Villiers JC, Mayaphi SH. Evaluation of the Determine™fourth generation HIV rapid assay. J Virol Methods. 2013; 189(1):180-3. doi: 10.1016/j.jviromet.2013.01.017 PMID: 23391823
33. Chetty V, Moodley D, Chuturgoon A. Evaluation of a 4th generation rapid HIV test for earlier and reliable detection of HIV infection in pregnancy. J Clin Virol. 2012; 54(2):180-4. doi: 10.1016/j.jcv.2012.02.021 PMID: 22445263
34. Conway DP, Holt M, McNulty A, Couldwell DL, Smith DE, Davies SC, et al. Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population. PLoS ONE 2014; 9(4):e94062. doi: 10.1371/journal.pone.0094062 PMID: 24714441
35. Faraoni S, Rocchetti A, Gotta F, Ruggiero T, Orofino G, Bonora S, et al. Evaluation of a rapid antigen and antibody combination test in acute HIV infection. J Clin Virol. 2013; 57(1):84-7. doi: 10.1016/j.jcv. 2013.01.007 PMID: 23380659
36. Fox J, Dunn H, O'Shea S. Low rates of p24 antigen detection using a fourth-generation point of care HIV test. Sex Trans Infect. 2010; 87(2):178-9.
37. Jones CB, Kuldanek K, Muir D, Phekoo K, Black A, Sacks R, et al. Clinical evaluation of the Determine HIV-1/2 Ag/Ab Combo test. J Infect Dis. 2012 Dec 15; 206(12):1947-9; author reply 9-50. doi: 10.1093/infdis/jis617 PMID: 23045627
38. Kilembe W, Keeling M, Karita E, Lakhi S, Chetty P, Price MA, et al. Failure of a novel, rapid antigen and antibody combination test to detect antigen-positive HIV infection in African adults with early HIV infection. PLoS ONE. 2012; 7(6):e37154. doi: 10.1371/journal.pone.0037154 PMID: 22715363
39. Laperche S, Leballais L, Ly TD, Plantier JC. Failures in the detection of HIV p24 antigen with the Determine HIV-1/2 Ag/Ab Combo rapid test. J Infect Dis. 2012 Dec 15; 206(12):1946-7; author reply 9-50. doi: 10.1093/infdis/jis616 PMID: 23045630
40. Masciotra S, Luo W, Youngpairoj AS, Kennedy MS, Wells S, Ambrose K, et al. Performance of the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast. J Clin Virol. [Research Support, U.S. Gov't, P.H. S.]. 2013 Dec; 58 Suppl 1:e54-8.
41. 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(1):42-7. doi: 10.1016/j.jcv.2012. 01.022 PMID: 22381919
42. 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
43. Pilcher CD, Louie B, Facente S, Keating S, Hackett J, Vallari A, et al. Performance of Rapid Point-of-Care 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
44. Rosenberg NE, Kamanga G, Phiri S, Nsona D, Pettifor A, Rutstein SE, et al. Detection of acute HIV infection: a field evaluation of the Determine HIV-1/2 Ag/Ab combo test. J Infect Dis. 2012 Feb 15; 205 (4):528-34. doi: 10.1093/infdis/jir789 PMID: 22207651
45. Stekler JD, O'Neal JD, Lane A, Swanson F, Maenza J, Stevens CE, et al. Relative accuracy of serum, whole blood, and oral fluid HIV tests among Seattle men who have sex with men. J Clin Virol. 2013; 58: e119-e22. doi: 10.1016/j.jcv.2013.09.018 PMID: 24342471
46. Duong YT, Mavengere Y, Patel H, Moore C, Manjengwa J, Sibandze D, et al. Poor performance of the determine HIV-1/2 Ag/Ab combo fourth-generation rapid test for detection of acute infections in a National Household Survey in Swaziland. J Clin Microbiol. 2014 Oct; 52(10):3743-8. doi: 10.1128/ JCM.01989-14 PMID: 25122853
47. Alere International Limited. The Alere Determine™HIV-1/ 2 Ag /Ab Combo Brochure. Ballybrit, Galway, Ireland: Alere International Limited; 2012 [September 2 2014]; Available from: http://alerehiv.s3. amazonaws.com/wp-content/uploads/12000140-v03-Alere-Determine-HIV-12-AgAb-Combo-Broc.pdf.
48. Willis BH. Spectrum bias - why clinicians need to be cautious when applying diagnostic test studies. Fam Pract. October 1, 2008; 25(5):390-6. doi: 10.1093/fampra/cmn051 PMID: 18765409
49. Cohen Myron S, Gay Cynthia L, Busch Michael P, Hecht Frederick M. The Detection of Acute HIV Infection. J Infect Dis. 2010; 202(S2):S270-S7.
50. Macaskill P, Gatsonis C, Deeks JJ, Harbord RM, Y T. Chapter 10: Analysing and Presenting Results. In: Deeks JJ, Bossuyt PM, C G, editors. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy The Cochrane Collaboration; 2010. p. 46-7.