Point of care diagnostics for sexually transmitted infections: Perspectives and advances

Expert Review of Anti-Infective Therapy

Volumn 12, Issue 6, 2014, Pages 657-672

  Gaydos, Charlotte ^a   Hardick, Justin ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Chlamydia trachomatis; HIV; HSV 2; Neisseria gonorrhoeae; PCR; point of care diagnostics; resource limited settings; serology; syphilis; Trichomonas vaginalis

Indexed keywords

EDETIC ACID;

AGGLUTINATION TEST; ARTICLE; CHLAMYDIASIS; DIAGNOSTIC APPROACH ROUTE; FLUORESCENT TREPONEMA ANTIBODY TEST; GONORRHEA; HERPES SIMPLEX; HERPES SIMPLEX VIRUS 1; HERPES SIMPLEX VIRUS 2; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOAFFINITY CHROMATOGRAPHY; NUCLEIC ACID AMPLIFICATION; POINT OF CARE TESTING; RAPID TEST; SENSITIVITY AND SPECIFICITY; SEROLOGY TEST KIT; SEXUALLY TRANSMITTED DISEASE; SYPHILIS; TRICHOMONIASIS; CHLAMYDIA INFECTIONS; CHLAMYDIA TRACHOMATIS; FEMALE; HIV INFECTIONS; HOSPITAL INFORMATION SYSTEM; HUMAN IMMUNODEFICIENCY VIRUS; ISOLATION AND PURIFICATION; MALE; NEISSERIA GONORRHOEAE; SEXUALLY TRANSMITTED DISEASES; TREPONEMA PALLIDUM; TRICHOMONAS VAGINALIS; TRICHOMONAS VAGINITIS;

CHLAMYDIA INFECTIONS; CHLAMYDIA TRACHOMATIS; FEMALE; GONORRHEA; HIV; HIV INFECTIONS; HUMANS; MALE; NEISSERIA GONORRHOEAE; POINT-OF-CARE SYSTEMS; SEXUALLY TRANSMITTED DISEASES; SYPHILIS; TREPONEMA PALLIDUM; TRICHOMONAS VAGINALIS; TRICHOMONAS VAGINITIS;

EID: 84901012642     PISSN: 14787210     EISSN: 17448336     Source Type: Journal    
DOI: 10.1586/14787210.2014.880651     Document Type: Article

References (149)

1. Satterwhite CL, Torrone E, Meites E, et al. Sexually transmitted infections among US women and men: prevalence and incidence estimates. 2008. Sex Transmit Dis 2013;40: 187-93
2. Owusu-Edusei JK, Chesson HW, Gift TL, et al. The estimated direct medical costs of selected sexually transmitted infections in the United States. 2008. Sex Transmit Dis 2013;40:197-201
3. Centers for Disease Control and Prevention. Sexually transmitted disease surveillance, 2011. Atlanta: U.S. Department of Health and Human Services, 2012. CDC 2012; 1-156
4. Pothier K, Kirtland M and Gupta S. Has Point-of care come of age? Point Care 2010;9:147-50
5. Gaydos CA, Quinn TC, Willis D, et al. Performance of the APTIMA. Combo 2 assay for the multiplex detection of Chlamydia trachomatis and Neisseria gonorrheae in female urine and endocervical swab specimens. J Clin Microbiol 2003;41: 304-9
6. Gaydos CA. Nucleic acid amplification tests for gonorrhea and chlamydia: practice and applications. In: Zenilman JM, Moellering RC Jr, editors. Infect Dis Clin N Am. Elsevier Saunders; Philadelphia, PA, USA: 2005
7. Gaydos CA, Cartwight CP, Colaninno P, et al. Performance of the Abbott RealTime CT/NG for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol 2010;48:3236-43
8. Taylor SN, Van Der Pol B, Lillis R, et al. Clinical evaluation of the BD. ProbeTecTM Chlamydia trachomatis (CT) Qx amplified DNA assay on the BD ViperTM system with XTRTM technology. Sex Transm Dis 2011;38:603-9
9. TM technology. Sex Transmit Dis 2012;39:147-53
10. Van Der Pol B, Liesenfeld O, Williams JA, et al. Performance of the cobas CT/NG test compared to the aptima AC2 and viper CTQ/GCQ assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol 2012;50: 2244-9
11. Van Der Pol B, Taylor SN, Liesenfeld O, et al. Vaginal swabs are the optimal specimen for detection of genital Chlamydia trachomatis or Neisseria gonorrhoeae using the cobas 4800 CT/NG test. Sex Transmit Dis 2013;40:247-50
12. Centers for Disease Control and Prevention. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae. MMWR 2014; In press
13. Schwebke JR, Hobbs M, Taylor S, et al. Molecular testing for Trichomonas vaginalis in women: results of a pivotal US clinical trial. J Clin Microbiol 2011;49:4106-11
14. Gravitt PE, Peyton CL, Apple RJ, Wheeler CM. Genotyping of 27 human papillomavirus types by using L1 consensus PCR products by a single-hybridization, reverse line blot detection method. J Clin Microbiol 1998;36:3020-7
15. Van Der Pol B, Warren T, Taylor SN, et al. Type-specific identification of anogenital herpes simplex virus infections by use of a commercially available nucleic acid amplification test. J Clin Microbiol 2012;50:3466-71
16. Shott JP, Galiwango RMm, Reynolds SJ. A Quality management approach to implementing point-of-care technologies for HIV diagnosis and monitoring in sub-Saharan Africa. J Trop Med 2012;2012: 1-8
17. van Dommelen L, van Tiel FH, Ouburg S, et al. Alarmingly poor performance in Chlamydia trachomatis point-of-care testing. Sex Transm Infect 2010;86:355-9
18. Gift TL, Pate M, Hook IEW, Kassler WJ. The rapid test paradox: when fewer cases detected lead to more cases treated, a decision analysis of tests for Chlamydia trachomatis. Sex Trans Dis 1999;26:232-40
19. Huang W, Gaydos CA, Barnes M, et al. Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting. Sex Transmit Infect 2013;89:108-14
20. Huppert JS, Hesse E, Gaydos CA. What's the point? How point-of-care sexually transmitted infection tests can impact infected patients. Point Care 2010;9:36-46
21. Hsieh YH, Hogan MT, Barnes M, et al. Perception of an ideal point-of-care test for sexually transmitted infections-a qualitative study of eight focus group discussions. PLoS One 2010;5:e14144
22. Hsieh YH, Gaydos CA, Hogan MT, et al. What qualities are most important to making a point of care test desirable for clinicians and others offering sexually transmitted infection testing? PLoS One 2011;6:e19263
23. Peeling RW, Holmes KK, Mabey D, et al. Rapid tests for sexually transmitted infections (STIs): the way forward. Sex Transm Infect 2006;82:v1-6
24. Gaydos CA. Chlamydia trachomatis. In: Marlene G, Rebecca T, Katherine R, editors. Women and Health. Academic Press; Elsevier; NY, USA: 2013
25. Bandea CI, Koumans EH, Sawyer MK, et al. Evaluation of the rapid BioStar optical immunoassay foe detection of Chlamydia trachomatis in adolescent women. J Clin Microbiol 2009;47:215-16
26. Pate MS, Dixon PB, Hardy K, et al. Evaluation of the BioStar chlamydia OIA assay with specimens from women attending a sexually transmitted disease clinic. J Clin Microbiol 1998;36:2183-6
27. Yin Y-P, Peeling RW, Chen X-S, et al. Clinic-based evaluation of Clearview chamydia MF for detection of Chlamydia trachomatis in vaginal and cervical specimens from women at risk in China. Sex Transm Infect 2006;82(Suppl):v33-7
28. Stratton NJ, Hirsch L, Harris F, et al. Evaluation of the rapid Clearview Chlamydia test for direct detection of chlamydiae from cervical specimens. J Clin Microbiol 1991;29:1551-3
29. Skulnick M, Small GW, Simor AE, et al. Comparison of the Clearview Chlamydia test, chlamydiazyme, and cell culture for detection of Chlamydia trachomatis in women with a low prevalence of infection. J Clin Microbiol 1991;29:2086-8
30. Steingrimsson O, Pawlak C, Van Der Pol B, et al. Multicenter comparative evaluation of two rapid immunoassay methods for the detection of Chlamydia trachomatis antigen in endocervical specimens. Clin Microbiol Infect 1997;3:663-7
31. Rani R, Corbitt G, Killough R, Curless E. Is there any role for rapid tests for Chlamydia trachomatis? Int J STD AIDS 2002;13:22-4
32. Mahilum-Tapay L, Laitila V, Wawrzyiak JJ, et al. New point of care chlamydia rapid test-bridging the gap between diagnosis and treatment: performance evaluation study. BMJ 2007;335:1190-4
33. Greer L, Wendel JG. Rapid diagnostic methods in sexually transmitted infections. Infect Dis Clin North Am 2008;22:601-17
34. van der Helm JJ, Sabajo LOA, Gruneberg AW, et al. Point-of-care tests for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname. PLoS One 2012;7:e32122
35. Hislop J, Quayyum Z, Fleet G, et al. Systematic review of the clinical effectiveness and cost-effectiveness of rapid point-of-care tests for the detection of genital chlamydia infection in women and men. Health Technol Assess 2010;14:1-125
36. Jain A, Ison CA. Chlamydia point-of-care testing: where are we now? Sex Transmit Infect 2013;89:88-9
37. Gaydos CA, Van Der Pol B, Jett-Goheen M, et al. Performance of the cepheid CT/NG X-pert rapid PCR test for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol 2013;51:1666-72
38. Tabrizi SN, Unemo M, Golparian D, et al. Analytical evaluation of the GenXpert CT/NG, the first genetic point-of-care assay for simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis. J Clin Microbiol 2013;51:1945-7
39. Hui BB, Wilson DP, Ward JS, et al. The potential impact of new generation molecular point-of-care tests on gonorrhoea and chlamydia in a setting of high endemic prevalence. Sex Health 2013;10:348-56
40. Pearce DM, Shenton DP, Holden J Gaydos CA. Evaluation of a novel electrochemical detection method for Chlamydia trachomatis: application for point-of-care diagnostics. IEEE Trans BioMed Eng 2011;58:755-8
41. Pribik R, Dragan AI, Zhang Y, et al. Metal-enhanced fluorescence (MEF): physical characterization of silver-island films and exploring sample geometrics. Chem Phys Lett 2009;478:70-4
42. Zang Y, Agreda P, Kelly S, et al. Development of a microwave-accelerated metal-enhanced fluorescence 40 second, 100 cfu/mL point of care assay for the detection of Chlamydia trachomatis. IEEE Trans BioMed Eng 2011;58:781-4
43. Melendez JH, Huppert JS, Jett-Goheen M, et al. Blind evaluation of the microwave-accelerated metal-enhanced fluorescence ultrarapid and sensitive Chlamydia trachomatis test by use of clinical samples. J Clin Microbiol 2013;51: 2913-20
44. Bolan GA, Sparling PF and Wasserheit JN. The emerging threat of untreatable gonoccocal infection. N Eng J Med 2012;366:485-7
45. Goldstein E, Kirkcaldy RD, Reshef D, et al. Factors related to increasing prevalence of resistance to ciprofloxacin and other antimicrobial drugs in Neisseria gonorrhoeae, United States. Emerg Infect Dis 2012;18:1290-7
46. Martin I, Sawatzky P, Allan V, et al. Emergence and characterization of Neisseria gonorrhoeae isolates with decreases susceptibilities to ceftriaxone and cefixime in Canada: 2001-2010. Sex Transmit Dis 2012;39:316-23
47. Sadiq ST, Dave J, Butcher PD. Point-of-care antibiotic susceptibility testing for gonorrhea: improving therapeutic options and sparing the use of cephalosporins. Sex Transmit Infect 2010;86:445-6
48. Smith LAW, Hillman R, Ward J, et al. Point-of-care tests for the diagnosis of Neisseria gonorrhoeae infection: a systematic review of operational and performance characteristics. Sex Transm Infect 2012;89: 320-6
49. 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 5):v29-32
50. Benzaken AS, Galban EG, Antunes W, et al. Diagnosis of gonococcal infection in high risk women using a rapid test. Sex Transm Infect 2006;82(Suppl 5):v26-8
51. Szuki K, Matsumoto T, Murakami H, et al. Evaluation of a rapid antigen detection test for Neisseria gonorrhoeae in urine sediment for diagnosis of gonococcal urethritis in males. J Infect Chemother 2004;10:208-11
52. Sparling PF, Swartz MN, Musher DM, Healy BP. Clinical manifestations of syphilis. In: Holmes KK, Sparling PF, Stamm WE, Piot P, Wasserheit JN, Corey L, Cohen MR, Watts DH, editors. Sexually transmitted disease. McGraw Hill; NY, USA: 2008
53. Stamm LV, Mudrak B. Old foes, new challenges: syphilis, cholera and TB. Future Microbiol 2013;8:177-9
54. Castro A, Jost H, Cox D, et al. A comparison of the analytical level of agreement of nine treponemal assays for syphilis and possible implications for screening algorithms. BMJ Open 2013;3: e003347
55. Binnicker MJ. Which algorithm should be used to screen for Syphilis? Curr Opin Infect Dis 2012;25:79-85
56. Centers for Disease Control and Prevention. Syphilis testing algorithms using treponemal tests for initial screening: four laboratories. New York City, 2005-2006. MMWR Morb Mortal Wkly Rep 2008;57:872-5
57. Centers for Disease Control and Prevention. Discordant results from reverse sequence Syphilis screening: five laboratories, United States 2006-2010. MMWR Morb Mortal Wkly Rep 2011;60:133-7
58. Syphilis health check. Available from: www. diagnosticsdirect2u.com/ images/PDF/Syphilis-Product-Sheet-May-2013.pdf
59. Tucker JD, Bu J, Brown LB, et al. Accelerating worldwide syphilis screening through rapid testing: a systematic review. Lancet Infect Dis 2010;10:381-6
60. 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):v13-16
61. Smit PW, Mabey D, Changalucha J, et al. The trade-off between accuracy and accessibility of Syphilis screening assays. PLoS One 2013;8:e75327
62. Yang LG, Tucker JD, Liu FY, et al. Syphilis screening among 27, 150 pregnant women in South Chinese rural areas using point-of-care tests. PLoS One 2013;8: e72149
63. Garcia PJ, Caramo CP, Chiappe M, et al. Rapid Syphilis tests as catalysts for health systems strengthening: a case study from Peru. PLoS One 2013;9:e66905
64. World Health Organization. Global incidence and prevalence of selected curable sexually transmitted infections-2008 Trichomonas. WHO, Geneva, Switzerland; 2012
65. Van Der Pol B, Williams JA, Orr DP, et al. Prevalence, incidence, natural history, and response to treatment of Trichomonas vaginalis infection among adolescent women. J Infect Dis 2005;192:2039-44
66. Weinstock H, Berman S, Cates W. Sexually transmitted disease among American youth: incidence and prevalence estimates. Perspect Sex Reprod Health 2004;36:6-10
67. Cotch MF, Pastorek JG, Nugent RP, et al. Trichomonas vaginalis associated with low birth weight and preterm delivery. Sex Transmit Dis 1997;24:353-60
68. Schwebke JR and Burgess D. Trichomoniasis. Clin Microbiol Review 2004;17:794-803
69. Sutton M, Sternberg M, Koumans EH, et al. The prevalence of Trichomonas vaginalis infection among reproductive-age women in the United States, 2001-2004. Clin Inf Dis 2007;45:1319-26
70. Miller WC, Swygard H, Hobbs MM, et al. The prevalence of trichomoniasis in young adults in the United States. Sex Tansmit Dis 2005;32:593-8
71. Allsworth JE, Ratner JA, Peipert JF. Trichomonas and other sexually transmitted infections: results from the 2001-2004. National Health and Nutrition Examination Surveys. Sex Tansmit Dis 2009;36:738-44
72. Kissinger P, Adamski A. Trichomoniasis and HIV interactions: a review. Sex Transmit 2013;89:426-33
73. Anderson BL, Firnhaber C, Liu T, et al. Effect of trichomoniasis therapy on genital HIV viral burden among African Women. Sex Transmit Dis 2012;39:638-42
74. Quinlivan EB, Patel SN, Grodensky CA, et al. Modeling the impact of Trichomonas vaginalis infection on HIV transmission in HIV-infected individuals in medical care. Sex Transm Dis 2012;39:671-7
75. Gaydos CA, Barnes MR, Quinn N, Jett-Gohneen M. Trichomonas vaginalis infection in men who submit self-collected penile swabs after internet recruitment. Sex Transm Infect 2013;89:505-8
76. Reagen MM, Xu H, Shih SL, et al. A randomized trial of home versus clinic-based sexually transmitted disease screening among men. Sex Transm Dis 2012;39:842-7
77. Hobbs MM, Sena AC. Modern diagnosis of Trichomonas vaginalis infection. Sex Transm Infect 2013;89:434-8
78. 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;43:684-7
79. Huppert JS, Mortensen JE, Reed JL, et al. Rapid antigen testing compares favorably with transcription-mediated amplification assay for the detection of Trichomonas vaginalis in young women. Clin Infect Dis 2007;45:194-8
80. Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol 2009;200:188.e1-188.e7
81. Pattullo L, Griffeth S, Ding L, et al. Stepwise diagnosis of Trichomonas vaginalis infection in adolescent women. J Clin Microbiol 2009;47:59-63
82. Madhivanan P, Li T, Trammell S, et al. Performance of the OSOM. Trichomonas rapid test for the diagnosis of Trichomonas vaginalis infection among women in Mysore, India. Sex Health 2013;10:320-4
83. Cartwright CP, Lembke BD, Ramachandran K, et al. Comparison of nucleic acid amplification assays with BD Affirm VPIII for diagnosis of vaginitis in symptomatic women. J Clin Microbiol 2013;51:3694-9
84. Pearce DM, Styles DN, Hardick J, Gaydos CA. A new rapid molecular point-of-care assay for Trichomonas vaginalis: preliminary performance data. Sex Transm Infect 2013;89:495-7
85. Corey L, Wald A. Genital herpes. In: Holmes KK, Sparling PF, Stamm WE, Piot P, Wasserheit JN, Corey L, Cohen MR, Watts DH, editors. Sexually transmitted diseases. McGraw Hill Medical; NY, USA: 2008
86. Markle W, Conti T, Kad M. Sexually transmitted diseases. Prim Care Clin Office Pract 2013;40:557-87
87. Centers for Disease Control and Prevention. Sexually transmitted disease treatment guidelines 2010. CDC 2010.59:1-110. Available from: www.cdc.gov/std/treatment/2010
88. Xu F, Sternberg MR, Kottiri BJ, et al. Trends in herpes simplex virus type 1 and type 2 seroprevalence in the United States. JAMA 2006;296:964-73
89. Johnston C, Koelle DM, Wald A. HSV-2: in pursuit of a vaccine. J Clin Invest 2013;121:4600-9
90. Rompalo A. Preventing sexually transmitted infections: back to basics. J Clin Invest 2012;12:4580-3
91. Fagundes LJ, Vieira EE Jr, Moyses ACMC, et al. Sexually transmitted diseases in a specialized STD healthcare center: epidemiology and demographic profile from January 1999 to December 2009. An Bras Dermatol 2013;88:523-9
92. Kenyon C, Colebunders R, Buve A, Hens N. Partner-concurrency associated with herpes simplex virus 2 infection in young South Africans. Inter J STD AIDS 2013;24:804-12
93. Kenyon C, Colebunders R, Hens N. Determinants of generalized herpes simplex virus-2 epidemics: the role of sexual partner concurrency. Inter J STD AIDS 2013;24: 375-82
94. Freeman EE, Weiss HA, Glynn JR, et al. Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS 2006;20:73-83
95. Zahariadis G, Severini A. Evaluation of a novel serology algorithm to detect herpes simplex virus 1 or 2 antibodies. Sex Transmit Dis 2010;37:696-9
96. Roth AM, Van Der Pol B, Fortenberry JD, et al. Herpes simplex virus type 2 serological testing at a community court: predictors of test acceptance and seropositivity among female defendants. Inter J STD AIDS 2013;24:169-74
97. Roth AM, Dodge BM, Van Der Pol B, Reece M Zimet GD. Low acceptance of HSV-2 testing among high-risk women. Inter J STD AIDS 2013;22:329-31
98. Biraro S, Mayaud P, Morrow A, et al. Performance of commercial herpes simplex virus type-2 antibody tests using serum samples from sub-Saharan Africa: a systematic review and meta-analysis. Sex Transmit Dis 2011;38:140-7
99. Gardella C, Huang ML, Wald A, et al. Rapid polymerase chain reaction assay to detect herpes simplex virus in the genital tract of women in labor. Obstet Gynecol 2010;115:1209-16
100. Chin CD, Laksanasopin T, Cheung YK, et al. Microfluidics-based diagnostics of infectious diseases in the developing world. Nat Med 2011;17:1015-19
101. Zubair A, Burbelo PD, Vincent LG, et al. Microfluidic LIPS for serum antibody detection: demonstration of a rapid test for HSV-2 infection. Biomed Microdevices 2011;13:1053-62
102. Lemieux B, Kong H, Tang YW. Near instrument-free, simple molecular device for rapid detection of herpes simplex viruses. Expert Rev Mol Diagn 2012;12:437-43
103. Kim HJ, Tong Y, Tang W, et al. A rapid and simple isothermal nucleic acid amplification test for detection of herpes simplex virus types 1 and 2. J Clin Virol 2011;50:26-30
104. Miller NS, Yen-Lieberman B, Poulter MD, et al. Comparative clinical evaluation of the IsoAMP® HSV Assay with ELVIS® HSV culture/ID/typing test system for the detection of herpes simplex virus in genital and oral lesions. J Clin Virol 2012;54:355-8
105. Hall H, Song R, Hodes P, et al. Estimation of HIV incidence in the United States. JAMA 2008;300:520-9
106. Centers for Disease Control and Prevention. HIV Surveillance report: estimated HIV incidence in the United States, 2007-2010. HIV Surveillance Supplemental Report 2012;17:1-26
107. Gaydos CA, Hsieh YH, Harvey L, et al. Will Patients "Opt-In" to perform their own rapid HIV test in the emergency department? Ann Emerg Med 2011;(Suppl 58):S74-8
108. Nour S, Hsieh Y-H, Jett-Goheen M, et al. Patients can accurately perform their own rapid HIV point-of-care test in the emergency department. Point Care J 2012;11:176-9
109. Mavedzenge SN, Baggaley R, Corbett E. A review of self-testing for HIV: research and policy priorities in a new era of HIV prevention. Clin Infect Dis 2013;57:126-38
110. Gaydos CA, Solis M, Hsieh YH, et al. Use of tablet-based kiosks in the emergency department to guide patient HIV self-testing with a point-of-care oral fluid test. Inter J STD AIDS 2013;24:714-21
111. Walensky RP, Paltiel AD. Rapid HIV Testing at home: does it solve a problem or create one? Ann Intern Med 2006;145: 459-62
112. Arora DR, Maheshwari M, Arora B. Rapid point-of-care testing for detection of HIV and clinical monitoring. ISRN AIDS 2013;2013:287269
113. Branson BM. State of the art for diagnosis of HIV infection. Clin Infect Dis 2007; 2007(Suppl):S221-5
114. Gaydos CA. Rapid tests for sexually transmitted diseases. Current Infect Dis Reports 2006;8:115-24
115. Pandori MW, Branson BM. 2010 HIV Diagnostics conference. Expert Rev Anti Infect Ther 2010;8:631-3
116. Centers for Disease Control and Prevention. Advantages and disadvantages of different types of FDA-approved HIV immunoassays used for screening by generation and platform. CDC 2013;10-25-0013
117. Hanafiah KM, Garcia M, Anderson D. Point-of-care testing and the control of infectious diseases. Biomark Med 2013;7: 333-47
118. Branson BM, Stekler JD. Detection of acute HIV infection: we can't close the window. J Infect Dis 2012;205:521-4
119. Rosenberg NE, Kamanga G, Phiri S, et al. Detection of acute HIV infection: a field evaluation of the Determine HIV-1/2 Ag/Ab Combo test. Detection of acute HIV infection: a field evaluation of the Determine HIV-1/2 Ag/Ab combo test. J Infect Dis 2012;205:528-34
120. OraQuick Advance Rapid HIV-1/2 Antibody Test [package insert]. 2004. Available from: www.oraquick.com/[Last accessed 25 October 2013]
121. Stekler JD, Swenson PD, Coombs RW, et al. HIV testing in a high-incidence population: is antibody testing alone good enough? Clin Infect Dis 2009;49:444-53
122. Reveall G3. Rapid HIV-1 antibody test [package insert]. 2006. Available from: www.medmira.com/images/uploads/RevealG3-NCCLS.pdf [Last accessed 25 October 2013]
123. Multispot HIV-1/HIV-2 Rapid Test [package insert]. 2004. Available from: www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ ApprovedProducts/PremarketApprovalsPMAs/ucm091384.pdf. [Last accessed 25 October 2013]
124. Centers for Disease Control and Prevention. Detection of acute HIV infection in two evaluations of a new HIV diagnostic testing algorithm-United States, 2011-2013. MMWR 2013;62:489-94
125. Uni-Gold Recombigen HIV [package insert]. 2004. Available from: www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ ApprovedProducts/PremarketApprovalsPMAs/ucm093428.pdf [Last accessed 25 October 2013]
126. Clearview HIV 1/2 STAT-PAK [package insert]. 2011. Available from: www.alere. com/us/en/product-details/clearview-hiv-1-2-STAT-PAK.html [Last accessed 25 October 2013]
127. Summary of safety and effectiveness Chembio DPP HIV 1/2 assay [package insert]. 2013. Available from: www.fda.gov/downloads/BiologicsBloodVaccines/ BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM333941.pdf [Last accessed 25 October 2013]
128. INSTI HIV-1 Antibody test kit [package insert]. 2013. Available from: www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ ApprovedProducts/PremarketApprovalsPMAs/UCM235249.pdf [Last accessed 25 October 2013]
129. Swenson RR, Hadley WS, Houck CD, et al. Who accepts a rapid HIV antibody test? The role of race/ethnicity and HIV risk behavior among community adolescents. J Adol Health 2011;48:527-9
130. Haukoos JS, Hopkins E, Conroy AA, et al. Routine opt-out rapid HIV screening and detection of HIV infection in emergency department patients. JAMA 2010;304: 284-92
131. Kendrick SR, Kroc KA, Withum D, et al. Outcomes of offering rapid point-of-care HIV testing in a sexually transmitted disease clinic. J Acquir Immune Defic Syndr 2005;38:142-6
132. Stack R, Mandalia S, McOwan A. Do HIV POCT testing algorithms help in clinical practice? Sex Transm Infect 2013;89:99
133. Galiwango RM, Musoke R, Lubyayi L, et al. Evaluation of current rapid HIV test algorithms in Rakai. Uganda. J Vir Methods 2013;192:25-7
134. Wright RJ, Stringer JSA. Rapid Testing Strategies for HIV-1 Serodiagnosis in High-prevalence African settings. Amer J Prev Med 2004;27:42-8
135. Advisory Committee Meeting GM3N2.2005 Approaches to over-the-counter home-use HIV test kits. FDA Blood Products. Available from: http://www.fda.gov/ ohrms/dockets/ac/05/briefing/2005-4190B1-01-issue% 20summary.htmon. [Last accessed 28 October 2013]
136. US FDA. 2011 Testing for HIV. Available from: http://wwwfdagov/ BiologicsBlood Vaccines/SafetyAvailability/HIVHome TestKits/ucm126460htm. [Last accessed 28 October 2013]
137. Reid SD, Fidler SJ, Cooke GS. Tracking the progress of HIV: the impact of point-of-care tests on antiretroviral therapy. Clin Epidemiol 2013;5:387-96
138. Myer L, Daskilewicz K, McIntyre J, Bekker LG. Comparison of point-of-care versus laboratory-based CD4 cell enumeration in HIV-positive pregnant women. J Inter AIDS Soc. 2013. Available from: http://dx.doi.org/10.7448/IAS.16.1.18649
139. Morawski BM, Meya DB, Boulware DR. Accuracy of Pima point-of-care CD4 analyzer in routine use in public health clinics in Uganda. J Acquir Immune Defic Syndr 2013;63:e113
140. Thaker M, Mahajan B, Shaikh N, et al. Utility of the point of care CD4 analyzer, PIMA, to enumerate CD4 counts in the field settings in India. AIDS Research Therapy 9. 2012. Available from: http://www. aidsrestherapy.com/ content/9-1/26
141. Rohram BA, Leautaud V, Molyneux E, Richards-Kortum RR. A lateral flow assay for quantitative detection of amplified HIV-1 RNA. PLoS One 2012;7:e45611
142. Wang SQ, Xu F, Demirci U. Advances in developing HIV-1 viral load assays for resource-limited settings. Biotechnol Adv 2010;28:770-81
143. Martinez AW, Phillips ST, Whitesides GM. Diagnostics for the developing world: microfluidic paper-based analytical devices. Anal Chem 2010;83:3-10
144. 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 Pub Group. 2006. Available from: www.nature. com/diagnostics 59-72
145. Schneider BH, Dickinson EL, Vach MD, et al. Optical chip immunoassay for hCG in human whole blood. Biosens Bioelectron 2000;15:597-604
146. Schneider BH, Dickinson EL, Vach MD, et al. Highly sensitive optical chip immunoassays in humans serum. Biosens Bioelectron 2000;15:13-22
147. Bisoffi M, Severns V, Larson R. CTSA-enhanced innovative device development. Clin Transl Sci 2012;5: 311-13
148. Bisoffi M, Hjelle B, Brown DC, et al. Detection of viral bioagents using a shear horizontal surface acoustic wave biosensor. Biosens Bioelectron 2008;23: 1397-403
149. Bisoffi M, Severns V, Branch DW, et al. Rapid detection of human immunodeficiency virus type 1 and 2 using an improved piezoelectric biosensor. J Clin Microbiol 2013;51:1685-91 Diseases