Utilisation of rapid tests for sexually transmitted infections: Promises and challenges

Open Infectious Diseases Journal

Volumn 3, Issue SPEC.ISS.1, 2009, Pages 156-168

  Peeling, Rosanna W ^a  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 82555187489     PISSN: None     EISSN: 18742793     Source Type: Journal    
DOI: 10.2174/1874279301004010156     Document Type: Article

References (111)

1. World Health Organization. Global prevalence and incidence of selected curable sexually transmitted infections: overview and estimates. Geneva: WHO, 2002. (WHO/HIV_AIDS/2001.02).
2. World Health Organization. Guidelines for the management of sexually transmitted infections. Geneva: World Health Organization; 2001 (WHO/ HIV_AIDS/2001.01).
3. Hawkes S, Morison L, Foster S, et al. Reproductive-tract infections in women in low-income, low-prevalence situations: assessment of syndromic management in Matlab, Bangladesh. Lancet 1999; 354: 1776-1781.
4. Pepin J, Deslandes S, Khonde N, et al. Low prevalence of cervical infections in women with vaginal discharge in West Africa: implications for syndromic management. Sex Transm Infect 2004; 80: 230.
5. Shamos SJ, Mettenbrink CJ, Subiadur JA, Mitchell BL, Rietmeijer CA. Evaluation of a testing-only express visit option to enhance efficiency in a busy STI clinic. Sex Transm Dis 2008; 35: 336.
6. Van Bergen JE, Postma MJ, Peerbooms PG, Spangenberg AC, Tjen-A-Tak J, Bindels PJ. Effectiveness and cost-effectiveness of a pharmacy-based screening programme for Chlamydia trachomatis in a high-risk health centre population in Amsterdam using mailed home-collected urine samples. Int J STD AIDS 2004; 15: 797-802.
7. Adams EJ, Garcia PJ, Garnett GP, Edmunds WJ, Holmes KK. The cost-effectiveness of syndromic management in pharmacies in Lima, Peru. Sex Transm Dis 2003; 30: 379-387.
8. Michel C-EC, Saison FG, Joshi H, Mahilum-Tapay LM, Lee HH. Pitfalls of internet-accessible diagnostic tests: inadequate performance of a CE-marked Chlamydia test for home use. Sex Transm Infect 2009; 85: 187-189.
9. Gaydos CA, Arora N, Owens SL, Peeling RW, Holmes KK. Can the Internet be Used to Access Testing for sexually transmitted infections? Abstract presented at the meeting of the British Association for Sexual Health and HIV and the American STD Association: New York, USA 2008.
10. Peeling RW. Testing for sexually transmitted infections: a brave new world? Sex Transm Infect 2006; 82: 425-430.
11. Levine DK, Scott KC, Klausner JD. Online syphilis testing - confidential and convenient. Sex Transm Dis 2005; 32: 139-141.
12. Gaydos CA, Dwyer K, Barnes M, et al. Internet based screening for Chlamydia trachomatis to reach non-clinic populations with mailed self-administered vaginal swabs. Sex Transm Dis 2006; 33: 451-457.
13. Rietmeijer CA, Bull SS, McFarlane M, Patnaik JL, Douglas JMJ. Risks and benefits of the internet for populations at risk for sexually transmitted infections (STIs): resu lts of an STI clinic survey. Sex Transm Dis 2003; 30: 15-19.
14. Koekenbier RH, Davidovich U, van Leent EJ, Thiesbrummel HF, Fennema HS. Online-mediated syphilis testing: feasibility, efficacy, and usage. Sex Transm Dis 2008; 35: 764.
15. Rietmeijer CA, Hopkins E, Geisler WM, Orr DP, Kent CK. Chlamydia trachomatis positivity rates among men tested in selected venues in the United States: a review of the recent literature. Sex Transm Dis 2008; 35: S8.
16. Khan MR, Rasolofomanana JR, McClamroch KJ, et al. High-risk sexual behavior at social venues in Madagascar. Sex Transm Dis 2008; 35: 738-745.
17. Barnabas RV, Wasserheit JN. Riddle of the Sphinx revisited: the role of STDs in HIV prevention. Sex Transm Dis 2009; 36: 365.
18. Branger J, van der Meer JT, van Ketel RJ, Jurriaans S, Prins JM. High incidence of asymptomatic syphilis in HIV-infected MSM justifies routine screening. Sex Transm Dis 2009; 36: 84.
19. Kendrick SR, Kroc KA, Withum D, Rydman RJ, Branson BM, Weinstein RA. Outcomes of offering rapid point-of-care HIV testing in a sexually transmitted disease clinic. J Acquir Immune Defic Syndr 2005; 38: 142.
20. Huhn GD, McIntyre AF, Broad JM, et al. Factors associated with newly diagnosed HIV among persons with concomitant sexually transmitted diseases. Sex Transm Dis 2008; 35: 731.
21. Klausner JD. Frequency of syphilis testing in HIV-infected patients: more and more often. Sex Transm Dis 2009; 36: 86.
22. Ruan Y, Cao X, Qian HZ, et al. Syphilis among female sex workers in southwestern China: potential for HIV transmission. Sex Transm Dis 2006; 33: 719.
23. Chen XS, Yin YP, Tucker JD, et al. Detection of acute and established HIV infections in STD clinics in Guangxi, China: implications for screening and prevention of HIV infection. J Infect Dis 2007; 196: 1654-1661.
24. Peeling RW, Mabey D, Holmes KK. Diagnostics for sexually transmitted infections: the way forward. Sex Transm Infect 2006; 82(Suppl V): 1-6.
25. Kettler H, White K, Hawkes S. Mapping the landscape of diagnostics for sexually transmitted infections. 2004 WHO/TDR publication.
26. World Bank. World Development Report 2004: Making Services Work for Poor People. New York: Oxford University Press for the World Bank 2004
27. Ward P. Near-patient tests will improve the control of sexually transmitted infections: the arguments in favour. Sex Transm Infect 2006; 82: 506-508.
28. Dean GL. Near-patient tests will not improve the control of sexually transmitted infections. Sex Transm Infect 2006; 82: 509-512.
29. Vickerman P, Peeling RW, Watts C, Mabey D. Detection of Gonococcal Infection: Pros and cons of a rapid test. Mol Diagn 2005; 9: 175-179.
30. Watson-Jones D, Changalucha J, Gumodoka B, et al. Syphilis in pregnancy in Tanzania. I: impact of maternal syphilis on outcome of pregnancy. J Infect Dis 2002; 186: 940-947.
31. Peeling RW, Ye H. Diagnostic tools for preventing and managing maternal and congenital syphilis: an overview. Bull World Health Organ 2004; 82: 439-446.
32. Stray-Pedersen B. Economic evaluation of maternal screening to prevent congenital syphilis. Sex Transm Dis 1983; 10: 167-172.
33. Connor N, Roberts J, Nicoll A. Strategic option for antenatal screening for syphilis in the United Kingdom: a cost effectiveness analysis. J Med Screen 2000; 7: 7-13.
34. Terris-Prestholt F, Watson-Jones D, Mugeye K, et al. Is antenatal syphilis screening still cost-effective in Sub-Saharan Africa? Sex Transm Infect 2003; 79: 375-381.
35. Gloyd S, Chai S, Mercer MA. Antenatal syphilis in sub-Saharan Africa: missed opportunities for mortality reduction. Health Policy Plann 2001; 16: 29-34.
36. Schmid G. Economic and programmatic aspects of congenital syphilis prevention. Bull World Health Organ 2004; 82: 402-409.
37. Southwick KL, Blanco S, Santander A, et al. Maternal and congenital syphilis in Bolivia, 1996: prevalence and risk factors. Bull World Health Organ 2001; 79: 33-42.
38. Fonn S. A blood-result turn-around time survey to improve congenital syphilis prevention in rural area. South Afr Med J 1996; 1: 67-71.
39. Hira SK, Bhat GJ, Chikamata DM, Nkowane B, Tembo G, Perine PL. Syphilis intervention in pregnancy: Zambian demonstration project. Genitourin Med 1990; 66: 159-164.
40. Jenniskens F, Obwaka E, Kirisuah S, et al. Syphilis control in pregnancy: decentralization of screening facilities to primary care level, a demonstration project in Nairobi, Kenya. Int J Gynecol Obstet 1995; 48(Suppl): S121-S128.
41. Fitzgerald DW, Behets F, Preval J, Schulwolf L, Bommi V, Chaillet P. Decreased congenital syphilis incidence in Haiti's rural Artibonite Region following decentralized prenatal screening. Am J Public Health 2003; 93: 444-446.
42. Temmerman M, Fonck K, Bashir F, et al. Declining syphilis prevalence in pregnant women in Nairobi since 1995: another success story in the STD field? Int J STD AIDS 1999; 10: 405-408.
43. Siedner M, Zapitz V, Ishida M, De la Roca R, Klausner JD. Performance of rapid syphilis tests in venous and whole blood specimens. Sex Transm Dis 2004; 31: 557-560.
44. Montoya PJ, Lukehart SA, Brentlinger PE, et al. Comparison of the diagnostic accuracy of a rapid immunochromatographic test and the rapid plasma regain test for antenatal syphilis screening in Mozambique. Bull World Health Organ 2006; 84: 97-104.
45. Herring AJ, Ballard RC, Pope V, et al. A multi-centre evaluation of nine rapid, point-of-care syphilis tests using archived sera. Sex Transm Infect 2006; 82(Suppl 5): v7-v12.
46. Tinajeros F, Grossman D, Richmond K, et al. Diagnostic accuracy of a point-of-care syphilis test when used among pregnant women in Bolivia. Sex Transm Infect 2006; 82(Suppl V): 17-21.
47. Campos PE, Buffardi AL, Chiappe M, et al. Utility of the determine syphilis TP rapid test in commercial sex venues in Peru. Sex Transm Infect 2006; 82(Suppl V): 22-25.
48. Bronzan RN, Mwesigwa-Kayongo DC, Narkunas D, et al. Onsite rapid antenatal syphilis screening with an immunochromatographic strip improves case detection and treatment in rural South African clinics. Sex Transm Dis 2007; 34: S55-S60.
49. Mabey D, Peeling RW, Ballard R, et al. Prospective, multi-centre clinic-based evaluation of four rapid diagnostic tests for syphilis. Sex Transm Infect 2006; 82(Suppl v): v13-v16
50. Creegan L, Bauer HM, Samuel MC, Klausner J, Liska S, Bolan G. An evaluation of the relative sensitiv ities o f the venereal disease research laboratory test and the Treponema pallidum particle agglutination test among patients diagnosed with primary syphilis. Sex Transm Dis 2007; 34: 1016.
51. Vickerman P, Peeling RW, Terris-Prestholt F, et al. Modeling the cost-effectiveness of introducing rapid syphilis tests into a antenatal syphilis screening programme in Mwanza, Tanzania. Sex Transm Infect 2006; 82 (Suppl V): v38-v43.
52. Schackman BR, Neukermans CP, Fontain SNN, Nolte C, Joseph P. Cost-effectiveness of rapid syphilis screening in prenatal HIV testing programs in Haiti. PLoS Med 2007; 4: 183.
53. Levin CE, Steele M, Atherly D, et al. Analysis of the operational costs of using rap id syphilis tests for the detection of maternal syphilis in Bolivia and Mozambique. SexTransm Dis 2007; 34: S47-S54.
54. Blandford JM, Gift T, Vasaiker S, et al. Cost-effectiveness of on-site antenatal screening to prevent congenital syphilis in rural Eastern Cape Province, Republic of South Africa. Sex Transm Dis 2007; 34: S61.
55. Peeling RW, Mabey D, Fitzgerald DW, Watson-Jones D. Avoiding HIV and dying of syphilis. Lancet 2004; 364: 1561-1563.
56. United States Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2006. Morb Mortal Wkly Rep Recomm 2006; 55(RR-11): 1-94.
57. Public Health Agency of Canada. STI Management Guidelines. Available from: http//:www.phac-aspc.gc.ca/dpg-eng.php
58. th ed. New York: MeGraw Hill 2008; pp. 937-57.
59. Gaydos CA, Theodore M, Dalesio N, Wood BJ, Quinn TC. Comparison of three nucleic acid amplification tests for detection of Chlamydia trachomatis in urine specimens. J Clin Microbiol 2004; 42: 3041-3045.
60. Schachter J, Chernesky MA, Willis DE, et al. Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections. Sex Transm Dis 2005; 32: 725-728.
61. Chernesky MA, Hook EW III, Martin DH, et al. Women find it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia trachomatis or Neisseria gonorrhoeae infections. Sex Transm Dis 2005; 32: 729-733.
62. Hobbs MM, Van Der Pol B, Totten P, et al. From the NIH: Proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexually transmitted infections. Sex Transm Dis 2008; 35: 8-13.
63. Hoebe CJPA, Rademaker CW, Brouwers EEHG, Ter Waarbeek HLG, Van Bergan JEAM. Acceptability of self-taken vaginal swabs and first-catch urine samples for the diagnosis of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae with an amplified DNA assay in young women attending a public health sexually transmitted disease clinic. Sex Transm Dis 2006; 33: 491-495.
64. Jones HE, Altini L, de Kock A, Young T, van de Wijgert JHHM. Home-based vs clinic-based self-sampling and testing for sexually transmitted infections in Gugulethu, South Africa: randomised trial. Sex Transm Infect 2007; 83: 552-557.
65. Lippman SA, Jones HE, Luppi CG, Pinho AA, Veras MAMS, van de Wijgert JHHM. Home-based self-sampling and self-testing for sexually transmitted infections: Acceptable and feasible alternatives to provider-based screening in low-income women in Sao Paulo, Brazil. Sex Tansm Dis 2007; 34: 421-428.
66. Novak DP, Lindholm L, Jonsson M, Karlsson RB. A Swedish cost-effectiveness analysis of community-based Chlamydia trachomatis PCR testing of postal urine specimens obtained at home. Scand J Public Health 2004; 32: 324-332.
67. van Valkengoed IG, Postma MJ, Morre SA, et al. Cost effectiveness analysis of a population based screening programme for asymptomatic Chlamydia trachomatis infections in women by means of home obtained urine specimens. Sex Transm Infect 2001; 77: 276-282.
68. Gaydos CA. Rapid tests for sexually transmitted diseases. Curr Infect Dis Rep 2006; 8: 115-124.
69. Benzaken AS, Galban EG, Antunes W, et al. The diagnosis of gonococcal infection in high risk women using a rapid test. Sex Transm Infect 2006; 82 (Suppl v): v26-v28.
70. Alary M, Gbenafa-Agossa C, Aina G, et al. Evaluation of a rapid point-of-care test for the detection of gonococcal infection among female sex workers in Benin. Sex Transm Infect 2006; 82(Suppl v): v29-v32.
71. Yin YP, Peeling RW, Chen XS, et al. Clinic-based evaluation of clearview Chlamydia MF for detection of Chlamydia trachomatis in vaginal and cervical specimens from women at high-risk in China. Sex Transm Infect 2006; 82 (suppl v): v33-v37.
72. Saison F, Mahilum-Tapay L, Michel CC, et al. Prevalence of Chlamydia trachomatis infection among low- and high-risk Filipino women and performance of Chlamydia rapid tests in resource-limited settings. J Clin Microbiol 2007; 45: 4011-4017.
73. Mahilum-Tapay L, Laitila V, Wawrzyniak JJ, et al. New point of care Chlamydia Rapid Test-bridging the gap between diagnosis and treatment: performance evaluation study. BMJ 2007; 335; 1190-1194.
74. Gift TL, Pate MS, Hook EW, Kassler WJ. The rapid test paradox: when fewer cases detected led to more cases treated. Sex Transm Dis 1999; 26: 232-240.
75. Vickerman P, Watts C, Alary M, Mabey D, Peeling RW. Sensitivity requirements for the point of care diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Infect 2003; 79: 363-367.
76. Vickerman P, Watts C, Peeling RW, Mabey D, Alary M. Modeling the impact and cost-effectiveness of rapid point-of-care diagnostic tests in an STI treatment intervention in Cotonou, Benin. Sex Transm Infect 2006; 82: 403-412.
77. Kissinger P, Amedee A, Clark RA, et al. Trichomonas vaginalis treatment reduces vaginal HIV-1 shedding. Sex Transm Dis 2009; 36: 11.
78. Sewankambo N, Gray RH, Wawa MJ, et al. HIV-1 infection associated with abnormal vaginal flora morphology and bacterial vaginosis. Lancet 1997; 350: 546.
79. Martin HL, Richardson BA, Nyange PM, et al. Vaginal lactobacilli, microbial flora, and risk of human immunodeficiency virus type 1 and sexually transmitted disease acquisition. J Infect Dis 1999; 180: 1863-1868.
80. Huppert JS, Batteiger BE, Braslins P, et al. Use of an immunochromatographic assay for rapid detection of Trichomonas vaginalis in vaginal specimens. J Clin Microbiol 2005; 43: 684-68.
81. Miller GA, Klausner JD, Meza R, et al. Assessment of a rapid antigen detection system for Trichomonas vaginalis infection. Clin Diag Lab Immunol 2003; 10: 1157.
82. Hillier S, Marrazzo J, Holmes KK. Bacterial Vaginosis. In: Holmes KK, Sparling PF, Stamm WE et al., Eds. Sexually Transmitted Diseases. 4th ed. New York: MeGraw Hill 2008: pp. 737-768.
83. Myziuk L, Romanowski B, Johnson SC. BV Blue test for diagnosis of bacterial vaginosis. J Clin Microbiol 2003; 41: 1925-1928.
84. Bradshow CS, Morton AN, Garland SM, Horvath LB, Kuzevska I, Fairley CK. Evaluation of a point-of-care test, BVBlue, and clinical and laboratory criteria for diagnosis of bacterial vaginosis. J Clin Microbiol 2005; 43: 1304-1308.
85. Wiggins R, Crowley T, Horner PJ, Soothill PW, Millar MR, Corfield AP. Use of 5-bromo-4-chloro-3-indoyl-a-D-N-acetylneuraminic acid in a novel spot test to identify sialidase activity in vaginal swabs from women with bacterial vaginosis. J Clin Microbiol 2000; 38: 3096-3097.
86. West B, Morrison L, Van Der Leoff MS, et al. Evaluation of a new rapid diagnostic kit (FemExam) for bacterial vaginosis in patients with vaginal discharge syndrome in The Gambia. Sex Transm Dis 2003; 30: 483-489.
87. Gallo MF, Warner L, Macaluso M, et al. Risk factors for incident herpes simplex type 2 virus infection among women attending a sexually transmitted disease clinic. Sex Transm Dis 2008; 35: 679.
88. Gardella C, Krantz E, Daruthayan C, Drolette L, Corey L, Wald A. The acceptance of HSV-testing partners of HSV-2 seronegative pregnant women. Sex Transm Dis 2009; 36: 211.
89. Fitzgerald DW, Behets FMTF. Beyond Folklore. J Am Med Assoc 2002; 288: 2791-2792
90. Gloyd S, Montoya P, Floriano F, Chadreque MC, Pfeiffer J, Gimbel-Sherr K. Scaling up antenatal syphilis screening in Mozambique: transforming policy to action. Sex Transm Dis 2007; 34: S31.
91. Petti CA, Polage CR, Quinn TC, Ronald AR, Sande MA. Laboratory medicine in Africa: a barrier to effective health care. Clin Infect Dis 2006; 42: 377-382.
92. Oliff M, Mayaud P, Brugha R, Semakafu AM. Integrating reproductive health services in a reforming health sector: the case of Tanzania. Reprod Health Matters 2003; 11: 37-48.
93. Pang T, Peeling RW. Diagnostic tests for infectious diseases in the developing world: two sides of the coin. Trans R Soc Trop Med Hyg 2007; 101: 856-857.
94. World Health Organization. Regulation of in vitro diagnostics: a global perspective. Annex in: diagnostics for tuberculosis: global demand and market potential. Geneva: WHO 2006; pp. 194-203.
95. Peeling RW, Smith PJ, Bossuyt PMM. A guide for diagnostic evaluations. Nat Microbiol Rev 2006; Suppl: S2-S6. Available from: http://www.nature.com/nrmicro/supplements
96. Plate DK on behalf of the Rapid HIV Test Evaluation Working Group. Evaluation and implementation of rapid HIV tests: the experience in 11 African countries. AIDS Res Hum Retroviruses 2007; 23: 1491-1498.
97. World Health Organization. Primary health care: now more than ever. The World Health Report 2008.
98. Ministry of Health and Population, Malawi. Essential Medical Laboratory Services Project, Malawi 1998-2002. Final Report published in 2003.
99. Schmid GP, Stoner BP, Hawkes S, Broutet N. The need and plan for global elimination of congenital syphilis. Sex Transm Dis 2007; 34: S5.
100. Fraser CM, Norris SJ, Weinstock GM, et al. Complete genome sequence of Treponema pallidum, the syphilis spirochete. Science 1998; 281: 375-381.
101. Stephens RS, Kalman S, Lammel C, et al. Genome sequence of an obligate intracellular pathogen of humans: Chlamydia trachomatis. Science 1998; 282: 754-759.
102. Pohlner J, Halter R, Beyreuther K, Meyer TF. Genome structure and extracellular secretion of Neisseria gonorrhoeae IgA protease. Nature 1987; 325: 458-462.
103. Sorger PK. Microfluidics closes in on point of care assays. Nat Biotechnol 2008; 26: 1345-1346.
104. Lewin Group. The value of diagnostics: innovation, adoption and diffusion into health care 2005.
105. WHO Task Force on Health Economics. Cost containment and cost analysis of TB control programmes: the case of Malawi 2003.
106. Hay Burgess DC, Wasserman J, Dahl CA. Global health diagnostics. Nature 2006; S1: 1-2. (23 November 2006). doi:10.1038/nature05440.
107. Urdea M, Penny LA, Olmsted SS, et al. Requirements for high impact diagnostics in the developing world: nature supplement: determining the global health impact of improved diagnostic technologies for the developing world. Nature 2006; S1: 73-79.
108. Aledort JE, Ronald A, Rafael ME, et al. Reducing the burden of sexually transmitted infections in resource-limited settings: the role of improved diagnostics. Nature 2006; 444(Suppl 1): 59-72.
109. Peeling RW, Mabey D, Herring A, Hook EW 3rd. Why do we need quality assured rapid diagnostic tests for sexually transmitted infections? Nat Rev Microbiol 2006; 4: 909-921.
110. Mboya-Okeyo T, Ridley RG, Nwaka S. The African network for Drugs and diagnostics innovation. Lancet 2009; 373: 1507-1508.
111. Point-of-Care Technologies Research Network. Available from: http://www.nibib.nih.gov/research/POCTRN