Objectives To assess clinical service value of STI point-of-care test (POCT) use in a ‘sample first’ clinical pathway (patients providing samples on arrival at clinic, before clinician consultation). Specific outcomes were: patient acceptability; whether a rapid nucleic acid amplification test (NAAT) for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) could be used as a POCT in practice; feasibility of non-NAAT POCT implementation for Trichomonas vaginalis (TV) and bacterial vaginosis (BV); impact on patient diagnosis and treatment.
Methods Service evaluation in a south London sexual health clinic. Symptomatic female and male patients and sexual contacts of CT/NG-positive individuals provided samples for diagnostic testing on clinic arrival, prior to clinical consultation. Tests included routine culture and microscopy; CT/NG (GeneXpert) NAAT; non-NAAT POCTs for TV and BV.
Results All 70 (35 males, 35 females) patients approached participated. The ‘sample first’ pathway was acceptable, with >90% reporting they were happy to give samples on arrival and receive results in the same visit. Non-NAAT POCT results were available for all patients prior to leaving clinic; rapid CT/NG results were available for only 21.4% (15/70; 5 males, 10 females) of patients prior to leaving clinic. Known negative CT/NG results led to two females avoiding presumptive treatment, and one male receiving treatment directed at possible Mycoplasma genitalium infection causing non-gonococcal urethritis. Non-NAAT POCTs detected more positives than routine microscopy (TV 3 vs 2; BV 24 vs 7), resulting in more patients receiving treatment.
Conclusions A ‘sample first’ clinical pathway to enable multiple POCT use was acceptable to patients and feasible in a busy sexual health clinic, but rapid CT/NG processing time was too long to enable POCT use. There is need for further development to improve test processing times to enable POC use of rapid NAATs.
- CLINICAL STI CARE
- SERVICE DELIVERY
- BACTERIAL INFECTION
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Contributors STS and EMH-E jointly conceived the study. EMH-E, AVN, AH, MJP, OO, AN, CML, PH and STS designed and planned the study and/or collected data. EMH-E, AVN and STS analysed the data. EMH-E and STS drafted the manuscript and all authors contributed to the manuscript.
Funding This work was supported by the UK Clinical Research Collaboration (Medical Research Council) Translation Infection Research Initiative Consortium (grant number G0901608).
Competing interests All authors have completed the International Committee of Medical Journal Editors uniform disclosure at http://www.icmje.org/coi_disclosure.pdf and declare: GeneXpert testing platform donation for the submitted work from Cepheid, and test kit donation support for the submitted work from Sekisui Diagnostics and Alere; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work. The Applied Diagnostic Research and Evaluation Unit at St George's, University of London, receives funding from the National Institute of Health Research (NIHR) i4i Programme (grant number II-LB-0214-20005), Atlas Genetics, Alere and Hologic to develop POCTs for STIs. The views expressed are those of the authors and not necessarily those of the NIHR, the NHS or the Department of Health.
Ethics approval Following review by the Interim Research Governance Lead of the Joint Research Office, St George's, the project was determined as fulfilling the criteria of a ‘service evaluation’.
Provenance and peer review Not commissioned; externally peer reviewed.
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