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RESEARCH ARTICLE

The potential impact of new generation molecular point-of-care tests on gonorrhoea and chlamydia in a setting of high endemic prevalence

Ben B. Hui A D , David P. Wilson A , James S. Ward B , Rebecca J. Guy A , John M. Kaldor A , Matthew G. Law A , Jane S. Hocking C and David G. Regan A
+ Author Affiliations
- Author Affiliations

A The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia.

B Baker IDI Heart and Diabetes Institute, Alice Springs, NT 0871, Australia.

C Centre for Women’s Health, Gender and Society, The University of Melbourne, Carlton, Vic. 3053, Australia.

D Corresponding author. Email: bhui@kirby.unsw.edu.au

Sexual Health 10(4) 348-356 https://doi.org/10.1071/SH13026
Submitted: 22 February 2013  Accepted: 4 May 2013   Published: 28 June 2013

Abstract

Background: Despite the availability of testing and treatment, bacterial sexually transmissible infections (STIs) continue to occur at endemic levels in many remote Indigenous communities in Australia. New generation molecular point-of-care (POC) tests have high sensitivity, comparable with conventional diagnostic tests, and have the potential to increase the impact of STI screening. Methods: We developed mathematical models of gonorrhoea (Neisseria gonorrhoeae) and chlamydia (Chlamydia trachomatis) transmission in remote Indigenous communities in Australia to evaluate screening and treatment strategies that utilise POC tests. Results: The introduction of POC testing with 95% sensitivity could reduce the prevalence of gonorrhoea and chlamydia from 7.1% and 11.9% to 5.7% and 8.9%, respectively, under baseline screening coverage of 44% per year. If screening coverage is increased to 60% per year, prevalence is predicted to be reduced to 3.6% and 6.7%, respectively, under conventional testing, and further reduced to 1.8% and 3.1% with the introduction of POC testing. Increasing screening coverage to 80% per year will result in a reduction in the prevalence of gonorrhoea and chlamydia to 0.6% and 1.5%, respectively, and the virtual elimination of both STIs if POC testing is introduced. Conclusions: Modelling suggests that molecular POC tests of high sensitivity have great promise as a public health strategy for controlling chlamydia and gonorrhoea. However, evaluation of the cost-effectiveness of POC testing needs to be made before widespread implementation of this technology can be considered.

Additional keywords: Australia, Indigenous, mathematical model, rapid tests, STIs, vulnerable populations.


References

[1]  Gerbase A, Stein C, Levinson J, Htun Y. Global burden of sexually transmitted diseases (excluding HIV) in the year 2000: global burden of disease 2000. Geneva: WHO; 2000.

[2]  Wasik M, Djuric Kachli M. A review of common sexually transmitted diseases. Formulary 2009; 44 78–86.
| 1:CAS:528:DC%2BD1MXksVOqs7k%3D&md5=1e17b24d84bc9b9ad56f126c38b465f1CAS |

[3]  Australian Government Department of Health and Ageing (DoHA). Third national Aboriginal and Torres Strait Islander blood borne viruses and sexually transmissible infections strategy 2010–2013. Canberra: DoHA; 2010.

[4]  Guy R, Garton L, Taylor-Thompson D, Silver B, Hengel B, Knox J, et al. The 2010 baseline prevalence study conducted by the STRIVE trial. Australasian Sexual Health Conference, 26–28 September 2011; 2011; National Convention Centre, Canberra, ACT, Australia.

[5]  Bowden FJ, Fethers K. “Let’s not talk about sex”: reconsidering the public health approach to sexually transmissible infections in remote Indigenous populations in Australia. Med J Aust 2008; 188 182–4.
| 18241182PubMed |

[6]  Guy R, Ward J, Smith K, Su J-Y, Huang R-L, Tangey A, et al The impact of sexually transmissible infection programs in remote Aboriginal communities in Australia: a systematic review. Sex Health 2012; 9 205–12.
| 22697136PubMed |

[7]  van Dommelen L, van Tiel FH, Ouburg S, Brouwers EEHG, Terporten PHW, Savelkoul PHM, et al Alarmingly poor performance in Chlamydia trachomatis point-of-care testing. Sex Transm Infect 2010; 86 355–9.
Alarmingly poor performance in Chlamydia trachomatis point-of-care testing.CrossRef | 20876754PubMed |

[8]  Mahilum-Tapay L, Laitila V, Wawrzyniak JJ, Lee HH, Alexander S, Ison C, et al New point of care chlamydia rapid test – bridging the gap between diagnosis and treatment: performance evaluation study. BMJ 2007; 335 1190–4.
New point of care chlamydia rapid test – bridging the gap between diagnosis and treatment: performance evaluation study.CrossRef | 18055487PubMed |

[9]  Watchirs Smith LA, Hillman R, Ward J, Whiley DM, Causer L, Skov S, 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; 89 320–326.
Point-of-care tests for the diagnosis of Neisseria gonorrhoeae infection: a systematic review of operational and performance characteristics.CrossRef | 23093736PubMed |

[10]  Gift TL. Nucleic acid amplification tests are more accurate and cost-effective than the chlamydia rapid test for diagnosing genital chlamydia. Evid Based Nurs 2010; 14 45–6.

[11]  Gift TL, Pate M, Hook EW, Kassler WJ. The rapid test paradox: when fewer cases detected lead to more cases treated: a decision analysis of tests for Chlamydia trachomatis. Sex Transm Dis 1999; 26 232–40.
The rapid test paradox: when fewer cases detected lead to more cases treated: a decision analysis of tests for Chlamydia trachomatis.CrossRef | 1:STN:280:DyaK1M3ktVWhsQ%3D%3D&md5=136ce5c47f568f86fdf584cb12df4b36CAS | 10225593PubMed |

[12]  Loubiere S, Moatti JP. Economic evaluation of point-of-care diagnostic technologies for infectious diseases. Clin Microbiol Infect 2010; 16 1070–6.
Economic evaluation of point-of-care diagnostic technologies for infectious diseases.CrossRef | 1:STN:280:DC%2BC3cjhtlWqtg%3D%3D&md5=7b4d9df76d17fc1f6c5596bfcc5d9c1aCAS | 20670289PubMed |

[13]  Watchirs Smith L, Hillman R, Ward J, Whiley DM, Causer L, Skov S, et al. Point-of-care tests for the detection of N. gonorrhoeae; a systematic review of operational characteristics and performance. Australasian Sexual Health Conference, 26–28 Sept 2011; 2011; National Convention Centre, Canberra, ACT, Australia.

[14]  Cheng H, Macaluso M, Vermund SH, Hook EW. Relative accuracy of nucleic acid amplification tests and culture in detecting chlamydia in asymptomatic men. J Clin Microbiol 2001; 39 3927–37.
Relative accuracy of nucleic acid amplification tests and culture in detecting chlamydia in asymptomatic men.CrossRef | 1:CAS:528:DC%2BD3MXoslWnt7o%3D&md5=4f8e791130ffc276ead8ad2a8f8236a3CAS | 11682509PubMed |

[15]  Nadala E-C, Goh BT, Magbanua J-P, Barber P, Swain A, Alexander S, et al Performance evaluation of a new rapid urine test for chlamydia in men: prospective cohort study BMJ 2009; 339 389–96.

[16]  Huang W, Gaydos CA, Barnes MR, Jett-Goheen M, Blake DR. Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting. Sex Transm Infect 2013; 89 108–14.
| 22984085PubMed |

[17]  Tabrizi S, Twin J, Unemo M, Limnios EA, Guy R. Analytical performance of GeneXpert® CT/NG, the first real-time PCR point-of-care assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. 13th IUSTI World Congress, 15–17 Oct 2012; Melbourne Convention and Exhibition Centre, Melbourne,Victoria, Australia. 2012;

[18]  Anderson RM, May RM. Infectious diseases of humans: dynamics and control. New York: Oxford University Press; 1991.

[19]  Keeling MJ, Rohani P. Modeling infectious diseases in human and animals. Princeton: Princeton University Press; 2008.

[20]  Smith K, Watson C, Senior K, Latif A. Central Australian STI risk factor study. Alice Springs: Sexual Health and BBV Unit, Centre for Disease Control, Department of Health and Families, Northern Territory Government; 2008.

[21]  Garnett GP, Mertz KJ, Finelli L, Levine WC, St Louis ME. The transmission dynamics of gonorrhoea: modelling the reported behaviour of infected patients from Newark, New Jersey. Philos Trans R Soc Lond B Biol Sci 1999; 354 787–97.
The transmission dynamics of gonorrhoea: modelling the reported behaviour of infected patients from Newark, New Jersey.CrossRef | 1:STN:280:DyaK1M3ptlOgug%3D%3D&md5=f92734f353ef3b672777758393f97f9dCAS | 10365404PubMed |

[22]  De Visser RO, Smith AMA, Rissel CE, Richters J, Grulich AE. Sex in Australia: heterosexual experience and recent heterosexual encounters among a representative sample of adults. Aust N Z J Public Health 2003; 27 146–54.
| 14696705PubMed |

[23]  Johnson LF, Alkema L, Dorrington RE. A Bayesian approach to uncertainty analysis of sexually transmitted infection models Sex Transm Infect 2010; 86 169–74.
A Bayesian approach to uncertainty analysis of sexually transmitted infection modelsCrossRef | 19880971PubMed |

[24]  Nganampa Health Council. Nganampa Health Council 2011 annual report. Alice Spring: Nganampa Health Council; 2012. Available at www.nganampahealth.com.au/download-reports-a-documents/doc_download/181-nganampa-health-council-2011-annual-report.html [verified 2012 April 5].

[25]  Latif A, Smith K. STI screening conducted in NT Department of Health and Community Services and Community Controlled Health Services in Central Australia in 2004. The Northern Territory Disease Control Bulletin 2004; 11(4): 18–20.

[26]  Huang R-L, Torzillo PJ, Hammond VA, Coulter ST, Kirby AC. Epidemiology of sexually transmitted infections on the Anangu Pitjantjatjara Yankunytjatjara Lands: results of a comprehensive control program. Med J Aust 2008; 189 442–5.
| 18928437PubMed |

[27]  Schwebke JR, Sadler R, Sutton JM, Hook EW. Positive screening tests for gonorrhea and chlamydial infection fail to lead consistently to treatment of patients attending a sexually transmitted disease clinic. Sex Transm Dis 1997; 24 181–4.
Positive screening tests for gonorrhea and chlamydial infection fail to lead consistently to treatment of patients attending a sexually transmitted disease clinic.CrossRef | 1:STN:280:DyaK2s3ls1aqtQ%3D%3D&md5=8e8279b18ba19e4d4bae3188cf7c1fc8CAS | 9101628PubMed |

[28]  Hook EW, Spitters C, Reichart CA, Neumann TM, Quinn TC. Use of cell culture and a rapid diagnostic assay for Chlamydia trachomatis screening. JAMA 1994; 272 867–70.
Use of cell culture and a rapid diagnostic assay for Chlamydia trachomatis screening.CrossRef | 8078164PubMed |

[29]  Garton L, Guy R, Silver B, Taylor-Thompson D, Hengel B, Knox J, et al. Australia’s largest clustered randomised trial in Aboriginal sexual health: progress toward a goal. Australasian Sexual Health Conference, 26–28 Sept 2011; 2011; National Convention Centre, Canberra, ACT, Australia.

[30]  Vickerman P, Watts C, Peeling RW, Mabey D, Alary M. 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. Sex Transm Infect 2006; 82 403–12.
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.CrossRef | 1:STN:280:DC%2BD28rotlKrtQ%3D%3D&md5=814673f1ef8f22894557dfaad6a7a431CAS | 17012515PubMed |

[31]  Northern Territory Government. Medicines, Poisons and Therapeutic Goods Act (No 13 of 2012, section 89) Darwin: Northern Territory Government; 2012. Available at http://www.austlii.edu.au/au/legis/nt/num_act/mpatga201213o2012425/s89.html [verified May 2013].

[32]  Vickerman P. Sensitivity requirements for the point of care diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae in women. Sex Transm Infect 2003; 79 363–7.
Sensitivity requirements for the point of care diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae in women.CrossRef | 1:STN:280:DC%2BD3svpslaqtA%3D%3D&md5=1630546eb30e4950da0c6e569870904eCAS | 14573829PubMed |

[33]  Hislop J, Quayyum Z, Flett G, Boachie C, Fraser C, Mowatt G. 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 1–97.
| 1:STN:280:DC%2BC3crhtlCmuw%3D%3D&md5=248540fa0ab0cbae8b52eec425c5cd59CAS | 20738930PubMed |

[34]  Katz AR, Effler PV, Ohye RG, Brouillet B, Veneranda M, Lee C, et al False positive gonorrhea test results with a nucleic acid amplification test: the impact of low prevalence on positive predictive value. Clin Infect Dis 2004; 38 814–9.
False positive gonorrhea test results with a nucleic acid amplification test: the impact of low prevalence on positive predictive value.CrossRef | 14999624PubMed |

[35]  Grimes DA, Schulz KF. Uses and abuses of screening tests. Lancet 2002; 359 881–4.
Uses and abuses of screening tests.CrossRef | 11897304PubMed |

[36]  The Kirby Institute. Bloodborne viral and sexually transmitted infections in Aboriginal and Torres Strait Islander people: surveillance and evaluation Report 2011. Sydney: The Kirby Institute, the University of New South Wales; 2011.

[37]  Dietz K, Hadeler KP. Epidemiological models for sexually transmitted diseases. J Math Biol 1988; 26 1–25.
Epidemiological models for sexually transmitted diseases.CrossRef | 1:STN:280:DyaL1c7ntFWhug%3D%3D&md5=8052b0a816878c451a3f2351c60474e1CAS | 3351391PubMed |

[38]  Ong JB, Fu X, Lee GKK, Chen MI. Comparability of results from pair and classical model formulations for different sexually transmitted infections. PLoS ONE 2012; 7
Comparability of results from pair and classical model formulations for different sexually transmitted infections.CrossRef | 22761828PubMed |

[39]  Rissel CE, Richters J, Grulich AE, de Visser RO, Smith AMA. Sex in Australia: selected characteristics of regular sexual relationships. Aust N Z J Public Health 2003; 27 124–30.
Sex in Australia: selected characteristics of regular sexual relationships.CrossRef | 14696702PubMed |

[40]  De Visser RO, Smith AMA, Rissel CE, Richters J, Grulich AE. Sex in Australia: safer sex and condom use among a representative sample of adults. Aust N Z J Public Health 2003; 27 223–9.
Sex in Australia: safer sex and condom use among a representative sample of adults.CrossRef | 14696715PubMed |

[41]  Hooper RR, Reynolds GH, Jones OG, Zaidi A, Wiesner PJ, Latimer K, et al Cohort study of venereal disease. 1: the risk of gonorrhoea transmission from infected women to men. Am J Epidemiol 1978; 108 136–44.
| 1:STN:280:DyaE1M%2FjvFaksw%3D%3D&md5=b61cad67563cf118dada70143023a441CAS | 707474PubMed |

[42]  Regan D, Wilson DP, Hocking JS. Coverage is the key for effective screening of Chlamydia trachomatis in Australia. J Infect Dis 2008; 198 349–58.
Coverage is the key for effective screening of Chlamydia trachomatis in Australia.CrossRef | 18588484PubMed |

[43]  McCutchan JA. Epidemiology of veneral urethritis: comparison of gonorrhea and nongonococcal urethritis. Rev Infect Dis 1984; 6 669–88.
Epidemiology of veneral urethritis: comparison of gonorrhea and nongonococcal urethritis.CrossRef | 1:STN:280:DyaL2M%2FmsFenuw%3D%3D&md5=74202b470ed15d89daf2daab66672222CAS | 6438766PubMed |

[44]  Harrison WO, Hooper RR, Wiesner PJ, Campbell AF, Karney WW, Reynolds GH, et al A trial of minocycline given after exposure to prevent gonorrhea. N Engl J Med 1979; 300 1074–8.
A trial of minocycline given after exposure to prevent gonorrhea.CrossRef | 1:STN:280:DyaE1M7ls1Krsw%3D%3D&md5=9fd0bae5c381a03c51bf47b1a1f525d6CAS | 107450PubMed |

[45]  Brunham RC, Garnett GP, Swinton J, Anderson RM. Gonococcal infection and human fertility in sub-Saharan Africa Proc R Soc Lond B Biol Sci 1991; 246 173–7.
Gonococcal infection and human fertility in sub-Saharan AfricaCrossRef | 1:STN:280:DyaK387itlOhtw%3D%3D&md5=c4142c242bfb9a3b8fe7ff130310a544CAS |

[46]  Althaus CL, Heijne JCM, Roellin A, Low N. Transmission dynamics of Chlamydia trachomatis affect the impact of screening programmes. Epidemics. 2010; 2 123–31.
Transmission dynamics of Chlamydia trachomatis affect the impact of screening programmes.CrossRef | 21352783PubMed |

[47]  Parks KS, Dixon PB, Richey CM, Hook EW. Spontaneous clearance of Chlamydia trachomatis infection in untreated patients. Sex Transm Dis 1997; 24 229–35.
Spontaneous clearance of Chlamydia trachomatis infection in untreated patients.CrossRef | 1:STN:280:DyaK2s3ls1ejtg%3D%3D&md5=0d54436102ff2d48e4945f7ef008b1d0CAS | 9101635PubMed |

[48]  Morré SA, Sillekens PT, Jacobs MV, de Blok S, Ossewaarde JM, van Aarle P, et al Monitoring of Chlamydia trachomatis infections after antibiotic treatment using RNA detection by nucleic acid sequence based amplification. Mol Pathol 1998; 51 149–54.
Monitoring of Chlamydia trachomatis infections after antibiotic treatment using RNA detection by nucleic acid sequence based amplification.CrossRef | 9850338PubMed |

[49]  Farley TA, Cohen DA, Elkins W. Asymptomatic sexually transmitted disease: the case for screening. Prev Med 2003; 36 502–9.
Asymptomatic sexually transmitted disease: the case for screening.CrossRef | 12649059PubMed |

[50]  Korenromp EL, Sudaryo MK, De Vlas SJ, Gray RH, Sewankambo NK, Serwadda D, et al What proportion of episodes of gonorrhoea and chlamydia becomes symptomatic? Int J STD AIDS 2002; 13 91–101.
What proportion of episodes of gonorrhoea and chlamydia becomes symptomatic?CrossRef | 11839163PubMed |

[51]  Cook RL, Hutchison SL, Østergaard L, Braithwaite RS, Ness RB. Systematic review: noninvasive testing for Chlamydia trachomatis and Neisseria gonorrhoeae. Ann Intern Med 2005; 142 914–25.
Systematic review: noninvasive testing for Chlamydia trachomatis and Neisseria gonorrhoeae.CrossRef | 15941699PubMed |

[52]  Rockett R, Goire N, Limnios A, Turra M, Higgens G, Lambert SB, et al Evaluation of the Cobas 4800 CT/NG test for detecting Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Infect 2010; 86 470–3.
Evaluation of the Cobas 4800 CT/NG test for detecting Chlamydia trachomatis and Neisseria gonorrhoeae.CrossRef | 20719957PubMed |

[53]  Spigarelli MG. Urine gonococcal/chlamydia testing in adolescents. Curr Opin Obstet Gynecol 2006; 18 498–502.
Urine gonococcal/chlamydia testing in adolescents.CrossRef | 16932043PubMed |



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