Utilisation of Rapid Tests for Sexually Transmitted Infections: Promises and Challenges

The control of curable STIs in countries with high disease burden has been hampered by the lack of accessible STI laboratory services. Rapid tests that are sensitive, specific and easy to use have the potential to increase the specificity of syndromic management of STIs in symptomatic patients and increase access to screening of asymptomatic infection to prevent the development of long-term complications and to interrupt the chain of transmission of STIs in the population. Although most rapid tests for chlamydia and gonorrhoea have sub-optimal sensitivity, and are neither simple nor affordable, some rapid syphilis tests have been shown to have acceptable performance. These can be deployed to increase access to screening in settings where testing is not previously possible or where laboratory services are inconsistent. With more political commitment and technological advances made possible by increased funding and public and private product development partnerships, there is much optimism in the near future for point of care tests for STIs that can improve patient management and disease control. The WHO estimates that more than 380 million new cases of sexually transmitted chlamydia, gonorrhea, syphilis and trichomoniasis occur worldwide every year (1). An equal or greater number of viral sexually transmitted infections (STIs) such as those caused by herpes simplex virus and human papilloma virus also occur every year but efforts to estimate the annual incidence of these infections on a global basis have been limited. THE NEED FOR STI DIAGNOSTICS Most STIs are asymptomatic but their consequences are serious. Undiagnosed and untreated STIs can lead to long term complications (Table 1). While complications are relatively rare in men, infections in women can lead to pelvic inflammatory disease and tubal infertility, a condition, which, in some societies renders a woman worthless. STIs also cause serious adverse outcomes in pregnancy for both the women and their foetus or infant. Affordable curative therapy is available for the major bacterial STIs. Screening and early treatment are therefore critical for effective patient management to prevent the development of long term complications and to interrupt onward transmission. For infected individuals with symptoms, STI laboratory services are scarce in most high burden countries, requiring patients to travel long distances to access these services.

[1]  K. Holmes,et al.  The Cost-Effectiveness of Syndromic Management in Pharmacies in Lima, Peru , 2003, Sexually transmitted diseases.

[2]  K. Workowski,et al.  Centers for Disease Control and Prevention Sexually Transmitted Disease Treatment Guidelines. , 2011, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[3]  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.

[4]  R. Brugha,et al.  Integrating Reproductive Health Services in a Reforming Health Sector: The Case of Tanzania , 2003, Reproductive health matters.

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

[6]  A. Nicoll,et al.  Strategic options for antenatal screening for syphilis in the United Kingdom: a cost effectiveness analysis , 2000, Journal of medical screening.

[7]  High-Risk Sexual Behavior at Social Venues in Madagascar , 2008, Sexually transmitted diseases.

[8]  S. Moses,et al.  Syphilis control in pregnancy: decentralization of screening facilities to primary care level, a demonstration project in Nairobi, Kenya , 1995, International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics.

[9]  Helen H. Lee,et al.  Prevalence of Chlamydia trachomatis Infection among Low- and High-Risk Filipino Women and Performance of Chlamydia Rapid Tests in Resource-Limited Settings , 2007, Journal of Clinical Microbiology.

[10]  U. Davidovich,et al.  Online-Mediated Syphilis Testing: Feasibility, Efficacy, and Usage , 2008, Sexually transmitted diseases.

[11]  Peter K Sorger,et al.  Microfluidics closes in on point-of-care assays , 2008, Nature Biotechnology.

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

[13]  T. Gift,et al.  Cost-Effectiveness of On-Site Antenatal Screening to Prevent Congenital Syphilis in Rural Eastern Cape Province, Republic of South Africa , 2007, Sexually transmitted diseases.

[14]  C. Gaydos,et al.  Internet-Based Screening for Chlamydia trachomatis to Reach Nonclinic Populations With Mailed Self-Administered Vaginal Swabs , 2006, Sexually transmitted diseases.

[15]  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.

[16]  N. Khonde,et al.  Low prevalence of cervical infections in women with vaginal discharge in west Africa: implications for syndromic management , 2004, Sexually Transmitted Infections.

[17]  D. Watson-Jones,et al.  Syphilis in pregnancy in Tanzania. I. Impact of maternal syphilis on outcome of pregnancy. , 2002, The Journal of infectious diseases.

[18]  A. Wald,et al.  The Acceptance of HSV-Testing Partners of HSV-2 Seronegative Pregnant Women , 2009, Sexually transmitted diseases.

[19]  C. Rietmeijer,et al.  Evaluation of a Testing-Only “Express” Visit Option to Enhance Efficiency in a Busy STI Clinic , 2008, Sexually transmitted diseases.

[20]  A. McIntyre,et al.  Factors Associated With Newly Diagnosed HIV Among Persons With Concomitant Sexually Transmitted Diseases , 2008, Sexually transmitted diseases.

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

[22]  A. Meheus,et al.  Syphilis intervention in pregnancy: Zambian demonstration project. , 1990, Genitourinary medicine.

[23]  J. Klausner,et al.  Online Syphilis Testing—Confidential and Convenient , 2005, Sexually transmitted diseases.

[24]  Lex M Bouter,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 , 2001, Sexually transmitted infections.

[25]  S. Hawkes,et al.  Mapping the landscape of diagnostics for sexually transmitted infections: key findings and recommendations. , 2004 .

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

[27]  S. Garland,et al.  Evaluation of a Point-of-Care Test, BVBlue, and Clinical and Laboratory Criteria for Diagnosis of Bacterial Vaginosis , 2005, Journal of Clinical Microbiology.

[28]  J. H. van de Wijgert,et al.  Home-based versus clinic-based self-sampling and testing for sexually transmitted infections in Gugulethu, South Africa: randomised controlled trial , 2007, Sexually Transmitted Infections.

[29]  M. Siedner,et al.  Performance of Rapid Syphilis Tests in Venous and Fingerstick Whole Blood Specimens , 2004, Sexually transmitted diseases.

[30]  P. Kirui,et al.  Declining syphilis prevalence in pregnant women in Nairobi since 1995: another success story in the STD field? , 1999, International journal of STD & AIDS.

[31]  R. W. Davis,et al.  Genome sequence of an obligate intracellular pathogen of humans: Chlamydia trachomatis. , 1998, Science.

[32]  J. Pfeiffer,et al.  Scaling Up Antenatal Syphilis Screening in Mozambique: Transforming Policy to Action , 2007, Sexually transmitted diseases.

[33]  B. Chohan,et al.  Vaginal lactobacilli, microbial flora, and risk of human immunodeficiency virus type 1 and sexually transmitted disease acquisition. , 1999, The Journal of infectious diseases.

[34]  Jeffrey Wasserman,et al.  Global health diagnostics , 2006, Nature.

[35]  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.

[36]  L. Morison,et al.  Evaluation of a New Rapid Diagnostic Kit (FemExam) for Bacterial Vaginosis in Patients With Vaginal Discharge Syndrome in The Gambia , 2003, Sexually transmitted diseases.

[37]  S. C. Johnson,et al.  BVBlue Test for Diagnosis of Bacterial Vaginosis , 2003, Journal of Clinical Microbiology.

[38]  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.

[39]  J. V. D. van der Meer,et al.  High Incidence of Asymptomatic Syphilis in HIV-Infected MSM Justifies Routine Screening , 2009, Sexually Transmitted Diseases.

[40]  D. Fitzgerald,et al.  Decreased congenital syphilis incidence in Haiti's rural Artibonite region following decentralized prenatal screening. , 2003, American journal of public health.

[41]  R. Hayes,et al.  Is antenatal syphilis screening still cost effective in sub-Saharan Africa , 2003, Sexually transmitted infections.

[42]  D. Grossman,et al.  Diagnostic accuracy of a point-of-care syphilis test when used among pregnant women in Bolivia , 2006, Sexually Transmitted Infections.

[43]  R. Peeling,et al.  A multi-centre evaluation of nine rapid, point-of-care syphilis tests using archived sera , 2006, Sexually Transmitted Infections.

[44]  M. McFarlane,et al.  Risks and Benefits of the Internet for Populations at Risk for Sexually Transmitted Infections (STIs): Results of an STI Clinic Survey , 2003, Sexually transmitted diseases.

[45]  R. Peeling,et al.  Sensitivity requirements for the point of care diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae in women , 2003, Sexually transmitted infections.

[46]  R. Peeling,et al.  Modelling the cost effectiveness of rapid point of care diagnostic tests for the control of HIV and other sexually transmitted infections among female sex workers , 2006, Sexually Transmitted Infections.

[47]  S. Gloyd,et al.  Antenatal syphilis in sub-Saharan Africa: missed opportunities for mortality reduction. , 2001, Health policy and planning.

[48]  B. Schackman,et al.  Cost-Effectiveness of Rapid Syphilis Screening in Prenatal HIV Testing Programs in Haiti , 2007, PLoS medicine.

[49]  R. Peeling,et al.  Modelling the cost-effectiveness of introducing rapid syphilis tests into an antenatal syphilis screening programme in Mwanza, Tanzania , 2006, Sexually Transmitted Infections.

[50]  S. Fonn A blood-result turn-around time survey to improve congenital syphilis prevention in a rural area. , 1996, South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde.

[51]  N. Sewankambo,et al.  HIV-1 infection associated with abnormal vaginal flora morphology and bacterial vaginosis , 1997, The Lancet.

[52]  M. Millar,et al.  Use of 5-Bromo-4-Chloro-3-Indolyl-α-d-N-Acetylneuraminic Acid in a Novel Spot Test To Identify Sialidase Activity in Vaginal Swabs from Women with Bacterial Vaginosis , 2000, Journal of Clinical Microbiology.

[53]  Claude-Edouard Michel,et al.  Pitfalls of internet-accessible diagnostic tests: inadequate performance of a CE-marked Chlamydia test for home use , 2006, Sexually Transmitted Infections.

[54]  Yiming Shao,et al.  Syphilis Among Female Sex Workers in Southwestern China: Potential for HIV Transmission , 2006, Sexually transmitted diseases.

[55]  R. Peeling,et al.  Detection of gonococcal infection : pros and cons of a rapid test. , 2005, Molecular diagnosis : a journal devoted to the understanding of human disease through the clinical application of molecular biology.

[56]  David H. Martin,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 , 2005, Sexually transmitted diseases.

[57]  K. Holmes,et al.  Utility of the Determine Syphilis TP rapid test in commercial sex venues in Peru , 2006, Sexually Transmitted Infections.

[58]  R. Peeling,et al.  Diagnostic tools for preventing and managing maternal and congenital syphilis: an overview. , 2004, Bulletin of the World Health Organization.

[59]  P. Ward Near-patient testing will improve the control of sexually transmitted infections: the arguments in favour , 2006, Sexually Transmitted Infections.

[60]  C. Levin,et al.  Analysis of the Operational Costs of Using Rapid Syphilis Tests for the Detection of Maternal Syphilis in Bolivia and Mozambique , 2007, Sexually transmitted diseases.

[61]  S. Nwaka,et al.  The African Network for Drugs and Diagnostics Innovation , 2009, The Lancet.

[62]  J. Klausner Frequency of syphilis testing in HIV-infected patients: more and more often. , 2009, Sexually transmitted diseases.

[63]  Cathy A Petti,et al.  Laboratory medicine in Africa: a barrier to effective health care. , 2006, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[64]  R. Peeling,et al.  Avoiding HIV and dying of syphilis , 2004, The Lancet.

[65]  P. Brentlinger,et al.  Comparison of the diagnostic accuracy of a rapid immunochromatographic test and the rapid plasma reagin test for antenatal syphilis screening in Mozambique. , 2006, Bulletin of the World Health Organization.

[66]  David H. Martin,et al.  Women Find It Easy and Prefer to Collect Their Own Vaginal Swabs to Diagnose Chlamydia trachomatis or Neisseria gonorrhoeae Infections , 2005, Sexually transmitted diseases.

[67]  K. Holmes,et al.  From the NIH: Proceedings of a Workshop on the Importance of Self-Obtained Vaginal Specimens for Detection of Sexually Transmitted Infections , 2008, Sexually transmitted diseases.

[68]  M. Postma,et al.  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 , 2004, International journal of STD & AIDS.

[69]  C. Gaydos,et al.  Erratum: Internet-based screening for Chlamydia trachomatis to reach nonclinic populations with mailed self-administered vaginal swabs (Sexually Transmitted Diseases (2006) 33, 7, (451-457)) , 2007 .

[70]  H. T. ter Waarbeek,et al.  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 , 2006, Sexually transmitted diseases.

[71]  C. Kent,et al.  Chlamydia trachomatis Positivity Rates Among Men Tested in Selected Venues in the United States: A Review of the Recent Literature , 2008, Sexually transmitted diseases.

[72]  J. Wasserheit,et al.  Riddle of the Sphinx revisited: the role of STDs in HIV prevention. , 2009, Sexually transmitted diseases.

[73]  G. Schmid Economic and programmatic aspects of congenital syphilis prevention. , 2004, Bulletin of the World Health Organization.

[74]  J. Chakraborty,et al.  Reproductive-tract infections in women in low-income, low-prevalence situations: assessment of syndromic management in Matlab, Bangladesh , 1999, The Lancet.

[75]  Mellisa L. Theodore,et al.  Comparison of Three Nucleic Acid Amplification Tests for Detection of Chlamydia trachomatis in Urine Specimens , 2004, Journal of Clinical Microbiology.

[76]  I. Brill,et al.  Risk Factors for Incident Herpes Simplex Type 2 Virus Infection Among Women Attending a Sexually Transmitted Disease Clinic , 2008, Sexually transmitted diseases.

[77]  B. Stray-Pedersen Economic Evaluation of Maternal Screening to Prevent Congenital Syphilis , 1983, Sexually transmitted diseases.

[78]  R. Peeling,et al.  A guide for diagnostic evaluations , 2006, Nature Reviews Microbiology.

[79]  J. Klausner,et al.  Assessment of a Rapid Antigen Detection System for Trichomonas vaginalis Infection , 2003, Clinical Diagnostic Laboratory Immunology.

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

[81]  S. Liska,et al.  An Evaluation of the Relative Sensitivities of the Venereal Disease Research Laboratory Test and the Treponema pallidum Particle Agglutination Test Among Patients Diagnosed With Primary Syphilis , 2007, Sexually transmitted diseases.

[82]  G. Schmid,et al.  The Need and Plan for Global Elimination of Congenital Syphilis , 2007, Sexually transmitted diseases.

[83]  S. Salzberg,et al.  Complete genome sequence of Treponema pallidum, the syphilis spirochete. , 1998, Science.

[84]  D. Filmer Determinants of Health and Education Outcomes Background Note for World Development Report 2004: Making Services Work for Poor People , 2003 .

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

[86]  T. Farley,et al.  Trichomonas Vaginalis Treatment Reduces Vaginal HIV-1 Shedding , 2009, Sexually transmitted diseases.

[87]  R. Peeling Testing for sexually transmitted infections: a brave new world? , 2006, Sexually Transmitted Infections.

[88]  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.

[89]  R. Peeling,et al.  Diagnostic tests for infectious diseases in the developing world: two sides of the coin. , 2007, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[90]  T. Meyer,et al.  Gene structure and extracellular secretion of Neisseria gonorrhoeae IgA protease , 1987, Nature.

[91]  G. Schmid,et al.  Onsite Rapid Antenatal Syphilis Screening With an Immunochromatographic Strip Improves Case Detection and Treatment in Rural South African Clinics , 2007, Sexually transmitted diseases.

[92]  W. Levine,et al.  Maternal and congenital syphilis in Bolivia, 1996: prevalence and risk factors. , 2001, Bulletin of the World Health Organization.