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

Accurate and inexpensive point-of-care (POC) tests are urgently needed to control sexually transmitted infection epidemics, so that patients can receive immediate diagnoses and treatment. Current POC assays for Chlamydia trachomatis and Neisseria gonorrhoeae perform inadequately and require better assays. Diagnostics for Trichomonas vaginalis rely on wet preparation, with some notable advances. Serological POC assays for syphilis can impact resource-poor settings, with many assays available, but only one available in the U.S. HIV POC diagnostics demonstrate the best performance, with excellent assays available. There is a rapid assay for HSV lesion detection; but no POC serological assays are available. Despite the inadequacy of POC assays for treatable bacterial infections, application of technological advances offers the promise of advancing POC diagnostics for all sexually transmitted infections.

[1]  N. Hens,et al.  Partner-concurrency associated with herpes simplex virus 2 infection in young South Africans , 2013, International journal of STD & AIDS.

[2]  Takashi Kawana,et al.  [Genital herpes]. , 2009, Nihon rinsho. Japanese journal of clinical medicine.

[3]  D. Low,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 , 1991, Journal of clinical microbiology.

[4]  Tetsuya Matsumoto,et al.  Evaluation of a rapid antigen detection test for Neisseria gonorrhoeae in urine sediment for diagnosis of gonococcal urethritis in males , 2004, Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy.

[5]  Joseph D Tucker,et al.  Accelerating worldwide syphilis screening through rapid testing: a systematic review. , 2010, The Lancet. Infectious diseases.

[6]  Xiangsheng Chen,et al.  Syphilis Screening among 27,150 Pregnant Women in South Chinese Rural Areas Using Point-of-Care Tests , 2013, PloS one.

[7]  A. Wald,et al.  Rapid Polymerase Chain Reaction Assay to Detect Herpes Simplex Virus in the Genital Tract of Women in Labor , 2010, Obstetrics and gynecology.

[8]  C. Gaydos Nucleic acid amplification tests for gonorrhea and chlamydia: practice and applications. , 2005, Infectious disease clinics of North America.

[9]  R. Peeling,et al.  Prospective, multi-centre clinic-based evaluation of four rapid diagnostic tests for syphilis , 2006, Sexually Transmitted Infections.

[10]  Fujie Xu,et al.  Trends in herpes simplex virus type 1 and type 2 seroprevalence in the United States. , 2006, JAMA.

[11]  Charlotte A Gaydos,et al.  A new rapid molecular point-of-care assay for Trichomonas vaginalis: preliminary performance data , 2013, Sexually Transmitted Infections.

[12]  R. Lillis,et al.  Clinical Evaluation of the BD ProbeTec™ Chlamydia trachomatis Qx Amplified DNA Assay on the BD Viper™ System With XTR™ Technology , 2011, Sexually transmitted diseases.

[13]  M. Gilmour,et al.  Emergence and Characterization of Neisseria gonorrhoeae Isolates With Decreased Susceptibilities to Ceftriaxone and Cefixime in Canada: 2001–2010 , 2012, Sexually transmitted diseases.

[14]  C. Ison,et al.  Chlamydia point-of-care testing: where are we now? , 2013, Sexually Transmitted Infections.

[15]  B. Branson,et al.  Detection of acute HIV infection: we can't close the window. , 2012, The Journal of infectious diseases.

[16]  H. Kong,et al.  Near instrument-free, simple molecular device for rapid detection of herpes simplex viruses , 2012, Expert review of molecular diagnostics.

[17]  L. Stamm,et al.  Old foes, new challenges: syphilis, cholera and TB. , 2013, Future microbiology.

[18]  P. Granato,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. , 2012, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[19]  E. Hook,et al.  Vaginal swabs are the optimal specimen for detection of genital Chlamydia trachomatis or Neisseria gonorrhoeae using the Cobas 4800 CT/NG test. , 2013, Sexually transmitted diseases.

[20]  P. Butcher,et al.  Point-of-care antibiotic susceptibility testing for gonorrhoea: improving therapeutic options and sparing the use of cephalosporins , 2010, Sexually Transmitted Infections.

[21]  B H Schneider,et al.  Optical chip immunoassay for hCG in human whole blood. , 2000, Biosensors & bioelectronics.

[22]  Rosanna W. Peeling,et al.  Rapid Syphilis Tests as Catalysts for Health Systems Strengthening: A Case Study from Peru , 2013, PloS one.

[23]  C. Peyton,et al.  Genotyping of 27 Human Papillomavirus Types by Using L1 Consensus PCR Products by a Single-Hybridization, Reverse Line Blot Detection Method , 1998, Journal of Clinical Microbiology.

[24]  M. Hobbs,et al.  Modern diagnosis of Trichomonas vaginalis infection , 2013, Sexually Transmitted Infections.

[25]  Dobb's journal staff Of interest , 2001, Administration in mental health.

[26]  M. Maheshwari,et al.  Rapid Point-of-Care Testing for Detection of HIV and Clinical Monitoring , 2013, ISRN AIDS.

[27]  Charlotte A Gaydos,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 , 2013, International journal of STD & AIDS.

[28]  A. Grant,et al.  Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. , 2010, Health technology assessment.

[29]  G. Mcquillan,et al.  The prevalence of Trichomonas vaginalis infection among reproductive-age women in the United States, 2001-2004. , 2007, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[30]  G. Mowatt,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. , 2010, Health technology assessment.

[31]  B. Branson State of the art for diagnosis of HIV infection. , 2007, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[32]  K. Mohd Hanafiah,et al.  Point-of-care testing and the control of infectious diseases. , 2013, Biomarkers in medicine.

[33]  A. Castro,et al.  A comparison of the analytical level of agreement of nine treponemal assays for syphilis and possible implications for screening algorithms , 2013, BMJ Open.

[34]  M. Binnicker Which algorithm should be used to screen for syphilis? , 2012, Current opinion in infectious diseases.

[35]  Metal-Enhanced Fluorescence (MEF): Physical Characterization of Siver-Island Films and Exploring Sample Geometries. , 2009, Chemical physics letters.

[36]  Jill S. Huppert,et al.  What Is the Point? How Point-of-care Sexually Transmitted Infection Tests Can Impact Infected Patients , 2010 .

[37]  Feng Xu,et al.  Advances in developing HIV-1 viral load assays for resource-limited settings. , 2010, Biotechnology advances.

[38]  M. Handcock,et al.  The Prevalence of Trichomoniasis in Young Adults in the United States , 2005, Sexually transmitted diseases.

[39]  Richard J Hayes,et al.  Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies , 2006, AIDS.

[40]  T. Quinn,et al.  Performance of the APTIMA Combo 2 Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Female Urine and Endocervical Swab Specimens , 2003, Journal of Clinical Microbiology.

[41]  Reena Mahajan,et al.  Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2008 , 2013, Sexually transmitted diseases.

[42]  A. Severini,et al.  Evaluation of a Novel Serology Algorithm to Detect Herpes Simplex Virus 1 or 2 Antibodies , 2010, Sexually transmitted diseases.

[43]  Federico Girosi,et al.  Reducing the burden of sexually transmitted infections in resource-limited settings: the role of improved diagnostics , 2006, Nature.

[44]  Michael L Wilson,et al.  Routine opt-out rapid HIV screening and detection of HIV infection in emergency department patients. , 2010, JAMA.

[45]  J. Papp,et al.  Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae--2014. , 2014, MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports.

[46]  Jill S. Huppert,et al.  Perceptions of an Ideal Point-of-Care Test for Sexually Transmitted Infections – A Qualitative Study of Focus Group Discussions with Medical Providers , 2010, PloS one.

[47]  Y. Hsieh,et al.  What Qualities Are Most Important to Making a Point of Care Test Desirable for Clinicians and Others Offering Sexually Transmitted Infection Testing? , 2011, PloS one.

[48]  Veronica Leautaud,et al.  A Lateral Flow Assay for Quantitative Detection of Amplified HIV-1 RNA , 2012, PloS one.

[49]  Jill S. Huppert,et al.  Use of an Immunochromatographic Assay for Rapid Detection of Trichomonas vaginalis in Vaginal Specimens , 2005, Journal of Clinical Microbiology.

[50]  F. V. van Tiel,et al.  Alarmingly poor performance in Chlamydia trachomatis point-of-care testing , 2010, Sexually Transmitted Infections.

[51]  C. Gaydos,et al.  Clinical Evaluation of the BD ProbeTec™ Neisseria gonorrhoeae Qx Amplified DNA Assay on the BD Viper™ System With XTR™ Technology , 2012, Sexually transmitted diseases.

[52]  R. Walensky,et al.  Rapid HIV Testing at Home: Does It Solve a Problem or Create One? , 2006, Annals of Internal Medicine.

[53]  S. Morré,et al.  Point-of-Care Test for Detection of Urogenital Chlamydia in Women Shows Low Sensitivity. A Performance Evaluation Study in Two Clinics in Suriname , 2012, PloS one.

[54]  E. Corbett,et al.  A Review of Self-Testing for HIV: Research and Policy Priorities in a New Era of HIV Prevention , 2013, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[55]  C. Smith,et al.  Chlamydia trachomatis. , 1989, New Jersey medicine : the journal of the Medical Society of New Jersey.

[56]  P. Rutter Testing for HIV. , 1993, Canadian family physician Medecin de famille canadien.

[57]  J. Fortenberry,et al.  Prevalence, incidence, natural history, and response to treatment of Trichomonas vaginalis infection among adolescent women. , 2005, The Journal of infectious diseases.

[58]  King K. Holmes Sexually Transmitted Disease , 1999 .

[59]  E. Hook,et al.  The rapid test paradox: when fewer cases detected lead to more cases treated: a decision analysis of tests for Chlamydia trachomatis. , 1999, Sexually transmitted diseases.

[60]  Stuart Berman,et al.  Perspectives on Sexual and Reproductive Health Sexually Transmitted Diseases among American Youth: Incidence and Prevalence Estimates, 2000 , 2022 .

[61]  Chris D. Geddes,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 , 2011, IEEE Transactions on Biomedical Engineering.

[62]  R. Peeling,et al.  The Trade-Off between Accuracy and Accessibility of Syphilis Screening Assays , 2013, PloS one.

[63]  S. Mandalia,et al.  Do HIV POCT testing algorithms help in clinical practice? , 2013, Sexually Transmitted Infections.

[64]  C. Schofield Sexually transmitted disease surveillance. , 1982, British medical journal.

[65]  V. Preedy,et al.  National Health and Nutrition Examination Survey , 2010 .

[66]  E. Hook,et al.  Evaluation of the Biostar Chlamydia OIA Assay with Specimens from Women Attending a Sexually Transmitted Disease Clinic , 1998, Journal of Clinical Microbiology.

[67]  C. Gaydos Rapid tests for sexually transmitted diseases , 2006, Current infectious disease reports.

[68]  R. Peeling,et al.  Evaluation of a rapid point-of-care test for the detection of gonococcal infection among female sex workers in Benin , 2006, Sexually Transmitted Infections.

[69]  G. Whitesides,et al.  Diagnostics for the developing world: microfluidic paper-based analytical devices. , 2010, Analytical chemistry.

[70]  Richard J. Wright,et al.  Rapid testing strategies for HIV-1 serodiagnosis in high-prevalence African settings. , 2004, American journal of preventive medicine.

[71]  M. Krohn,et al.  Trichomonas vaginalis Associated With Low Birth Weight and Preterm Delivery , 1997, Sexually transmitted diseases.

[72]  G. Zimet,et al.  Low acceptance of HSV-2 testing among high-risk women , 2011, International journal of STD & AIDS.

[73]  G. Corbitt,et al.  Is there any role for rapid tests for Chlamydia trachomatis? , 2002, International journal of STD & AIDS.

[74]  D W Branch,et al.  Detection of viral bioagents using a shear horizontal surface acoustic wave biosensor. , 2008, Biosensors & bioelectronics.

[75]  A. Caliendo,et al.  Effect of Trichomoniasis Therapy on Genital HIV Viral Burden Among African Women , 2012, Sexually transmitted diseases.

[76]  C. Gaydos,et al.  Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae , 2013, Journal of Clinical Microbiology.

[77]  William C Miller,et al.  Detection of acute HIV infection: a field evaluation of the determine® HIV-1/2 Ag/Ab combo test. , 2012, The Journal of infectious diseases.

[78]  Y. K. Cheung,et al.  1 Supplementary Information for : Microfluidics-based diagnostics of infectious diseases in the developing world , 2011 .

[79]  Charlotte A Gaydos,et al.  Patients Can Accurately Perform Their Own Rapid HIV Point-of-Care Test in the Emergency Department. , 2012, Point of care.

[80]  R. Peeling,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 , 2006, Sexually Transmitted Infections.

[81]  A. Weissfeld,et al.  Multicenter comparative evaluation of two rapid immunoassay methods for the detection of Chlamydia trachomatis antigen in endocervical specimens. , 1997, Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases.

[82]  J. Schwebke,et al.  Comparison of Nucleic Acid Amplification Assays with BD Affirm VPIII for Diagnosis of Vaginitis in Symptomatic Women , 2013, Journal of Clinical Microbiology.

[83]  M. Unemo,et al.  Analytical Evaluation of GeneXpert CT/NG, the First Genetic Point-of-Care Assay for Simultaneous Detection of Neisseria gonorrhoeae and Chlamydia trachomatis , 2013, Journal of Clinical Microbiology.

[84]  G. Wendel,et al.  Rapid diagnostic methods in sexually transmitted infections. , 2008, Infectious disease clinics of North America.

[85]  E. Peterson,et al.  Evaluation of the rapid CLEARVIEW Chlamydia test for direct detection of chlamydiae from cervical specimens , 1991, Journal of clinical microbiology.

[86]  C. Golin,et al.  Modeling the Impact of Trichomonas vaginalis Infection on HIV Transmission in HIV-Infected Individuals in Medical Care , 2012, Sexually transmitted diseases.

[87]  R. Gray,et al.  Evaluation of current rapid HIV test algorithms in Rakai, Uganda. , 2013, Journal of virological methods.

[88]  A. Rompalo Preventing sexually transmitted infections: back to basics. , 2011, The Journal of clinical investigation.

[89]  Nancy S Miller,et al.  A rapid and simple isothermal nucleic acid amplification test for detection of herpes simplex virus types 1 and 2. , 2011, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[90]  David N. Reshef,et al.  Factors Related to Increasing Prevalence of Resistance to Ciprofloxacin and Other Antimicrobial Drugs in Neisseria gonorrhoeae, United States , 2012, Emerging infectious diseases.

[91]  J. Peipert,et al.  A Randomized Trial of Home Versus Clinic-Based Sexually Transmitted Disease Screening Among Men , 2012, Sexually transmitted diseases.

[92]  H. Weiss,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 , 2011, Sexually transmitted diseases.

[93]  Jill S. Huppert,et al.  Rapid antigen testing compares favorably with transcription-mediated amplification assay for the detection of Trichomonas vaginalis in young women. , 2007, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[94]  L. Myer,et al.  Comparison of point-of-care versus laboratory-based CD4 cell enumeration in HIV-positive pregnant women , 2013, Journal of the International AIDS Society.

[95]  C. Gaydos,et al.  Molecular Testing for Trichomonas vaginalis in Women: Results from a Prospective U.S. Clinical Trial , 2011, Journal of Clinical Microbiology.

[96]  C. Geddes,et al.  Blind Evaluation of the Microwave-Accelerated Metal-Enhanced Fluorescence Ultrarapid and Sensitive Chlamydia trachomatis Test by Use of Clinical Samples , 2013, Journal of Clinical Microbiology.

[97]  Lisa M. Lee,et al.  Estimation of HIV incidence in the United States. , 2008, JAMA.

[98]  D. Feikin,et al.  Detection of acute HIV infection in two evaluations of a new HIV diagnostic testing algorithm - United States, 2011-2013 References , 2014 .

[99]  J. Kaldor,et al.  The potential impact of new generation molecular point-of-care tests on gonorrhoea and chlamydia in a setting of high endemic prevalence. , 2013, Sexual health.

[100]  Christelle Vancutsem,et al.  A Vectorial Capacity Product to Monitor Changing Malaria Transmission Potential in Epidemic Regions of Africa , 2012, Journal of tropical medicine.

[101]  B H Schneider,et al.  Highly sensitive optical chip immunoassays in human serum. , 2000, Biosensors & bioelectronics.

[102]  Jenifer E. Allsworth,et al.  Trichomoniasis and Other Sexually Transmitted Infections: Results From the 2001–2004 National Health and Nutrition Examination Surveys , 2009, Sexually transmitted diseases.

[103]  Y. Hsieh,et al.  Trichomonas vaginalis infection in men who submit self-collected penile swabs after internet recruitment , 2013, Sexually Transmitted Infections.

[104]  M. Golden,et al.  HIV testing in a high-incidence population: is antibody testing alone good enough? , 2009, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[105]  S. Reynolds,et al.  A Quality Management Approach to Implementing Point-of-Care Technologies for HIV Diagnosis and Monitoring in Sub-Saharan Africa , 2012, Journal of tropical medicine.

[106]  Sonia Gupta,et al.  Has Point-of-Care Come of Age? , 2010 .

[107]  B. Branson,et al.  Outcomes of Offering Rapid Point-of-Care HIV Testing in A Sexually Transmitted Disease Clinic , 2005, Journal of acquired immune deficiency syndromes.

[108]  Margaret-Mary G. Wilson,et al.  Sexually transmitted diseases. , 2003, Clinics in geriatric medicine.

[109]  P. Kissinger,et al.  Trichomoniasis and HIV interactions: a review , 2013, Sexually Transmitted Infections.

[110]  M. Iadarola,et al.  Microfluidic LIPS for serum antibody detection: demonstration of a rapid test for HSV-2 infection , 2011, Biomedical microdevices.

[111]  R. Paranjape,et al.  Utility of the point of care CD4 analyzer, PIMA, to enumerate CD4 counts in the field settings in India , 2012, AIDS Research and Therapy.

[112]  Jill S. Huppert,et al.  Stepwise Diagnosis of Trichomonas vaginalis Infection in Adolescent Women , 2008, Journal of Clinical Microbiology.

[113]  R. Lillis,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 , 2012, Journal of Clinical Microbiology.

[114]  Wilson Dj Clinical manifestations of syphilis. , 1947 .

[115]  G. Cooke,et al.  Tracking the progress of HIV: the impact of point-of-care tests on antiretroviral therapy , 2013, Clinical epidemiology.

[116]  A. Wald,et al.  HSV-2: in pursuit of a vaccine. , 2011, The Journal of clinical investigation.

[117]  R. Peeling,et al.  Rapid tests for sexually transmitted infections (STIs): the way forward , 2006, Sexually Transmitted Infections.

[118]  J. Papp,et al.  Evaluation of the Rapid BioStar Optical Immunoassay for Detection of Chlamydia trachomatis in Adolescent Women , 2008, Journal of Clinical Microbiology.

[119]  B. Branson,et al.  2010 HIV Diagnostics Conference , 2010, Expert review of anti-infective therapy.

[120]  Helen H. Lee,et al.  New point of care Chlamydia Rapid Test—bridging the gap between diagnosis and treatment: performance evaluation study , 2007, BMJ : British Medical Journal.

[121]  L. Brown,et al.  Who accepts a rapid HIV antibody test? The role of race/ethnicity and HIV risk behavior among community adolescents. , 2011, The Journal of adolescent health : official publication of the Society for Adolescent Medicine.

[122]  J. Wasserheit,et al.  The emerging threat of untreatable gonococcal infection. , 2012, The New England journal of medicine.

[123]  J. Kaldor,et al.  Point-of-care tests for the diagnosis of Neisseria gonorrhoeae infection: a systematic review of operational and performance characteristics , 2012, Sexually Transmitted Infections.

[124]  N. Hens,et al.  Determinants of generalized herpes simplex virus-2 epidemics: the role of sexual partner concurrency , 2013, International journal of STD & AIDS.

[125]  J. Welsch,et al.  Performance of the Abbott RealTime CT/NG for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae , 2010, Journal of Clinical Microbiology.

[126]  R. Peeling,et al.  Diagnosis of gonococcal infection in high risk women using a rapid test , 2006, Sexually Transmitted Infections.

[127]  E. Hook,et al.  Type-Specific Identification of Anogenital Herpes Simplex Virus Infections by Use of a Commercially Available Nucleic Acid Amplification Test , 2012, Journal of Clinical Microbiology.

[128]  G. Sen,et al.  Women and Health: the key for sustainable development , 2015, The Lancet.

[129]  C. Gaydos,et al.  Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting , 2012, Sexually Transmitted Infections.

[130]  D. Branch,et al.  Rapid Detection of Human Immunodeficiency Virus Types 1 and 2 by Use of an Improved Piezoelectric Biosensor , 2013, Journal of Clinical Microbiology.

[131]  Patricia Agreda,et al.  Will patients "opt in" to perform their own rapid HIV test in the emergency department? , 2011, Annals of emergency medicine.

[132]  J. Klausner,et al.  Performance of the OSOM Trichomonas Rapid Test for diagnosis of Trichomonas vaginalis infection among women in Mysore, India. , 2013, Sexual health.

[133]  J. Schwebke,et al.  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. , 2009, American journal of obstetrics and gynecology.

[134]  David M Pearce,et al.  Evaluation of a Novel Electrochemical Detection Method for Chlamydia trachomatis : Application for Point-of-Care Diagnostics , 2011, IEEE Transactions on Biomedical Engineering.

[135]  J. Fortenberry,et al.  Herpes simplex virus type 2 serological testing at a community court: Predictors of test acceptance and seropositivity among female defendants , 2013, International journal of STD & AIDS.

[136]  Reena Mahajan,et al.  The Estimated Direct Medical Cost of Selected Sexually Transmitted Infections in the United States, 2008 , 2013, Sexually transmitted diseases.