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      Impact of deploying multiple point-of-care tests with a ‘sample first’ approach on a sexual health clinical care pathway. A service evaluation

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          Abstract

          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.

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          Most cited references21

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          SQUIRE 2.0—Standards for Quality Improvement Reporting Excellence—Revised Publication Guidelines from a Detailed Consensus Process

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            Existing and Emerging Technologies for Point-of-Care Testing.

            The volume of point-of-care testing (PoCT) has steadily increased over the 40 or so years since its widespread introduction. That growth is likely to continue, driven by changes in healthcare delivery which are aimed at delivering less costly care closer to the patient's home. In the developing world there is the challenge of more effective care for infectious diseases and PoCT may play a much greater role here in the future. PoCT technologies can be split into two categories, but in both, testing is generally performed by technologies first devised more than two decades ago. These technologies have undoubtedly been refined and improved to deliver easier-to-use devices with incremental improvements in analytical performance. Of the two major categories the first is small handheld devices, providing qualitative or quantitative determination of an increasing range of analytes. The dominant technologies here are glucose biosensor strips and lateral flow strips using immobilised antibodies to determine a range of parameters including cardiac markers and infectious pathogens. The second category of devices are larger, often bench-top devices which are essentially laboratory instruments which have been reduced in both size and complexity. These include critical care analysers and, more recently, small haematology and immunology analysers. New emerging devices include those that are utilising molecular techniques such as PCR to provide infectious disease testing in a sufficiently small device to be used at the point of care. This area is likely to grow with many devices being developed and likely to reach the commercial market in the next few years.
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              Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae.

              Tests for Chlamydia trachomatis and Neisseria gonorrhoeae, which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being ≥ 99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being ≥ 99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts.
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                Author and article information

                Journal
                Sex Transm Infect
                Sex Transm Infect
                sextrans
                sti
                Sexually Transmitted Infections
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                1368-4973
                1472-3263
                September 2017
                3 February 2017
                : 93
                : 6
                : 424-429
                Affiliations
                [1 ] Applied Diagnostic Research and Evaluation Unit, St George's University of London, Institute for Infection & Immunity , London, UK
                [2 ] HIV/STI Department, National Infection Service, Public Health England , London, UK
                [3 ] Courtyard Clinic, St George's University Hospitals NHS Foundation Trust , London, UK
                Author notes
                [Correspondence to ] Dr S Tariq Sadiq, St George's University of London, Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, Cranmer Terrace, Tooting, London SW17 0RE, UK; ssadiq@ 123456sgul.ac.uk
                Author information
                http://orcid.org/0000-0002-1432-8109
                Article
                sextrans-2016-052988
                10.1136/sextrans-2016-052988
                5574381
                28159916
                b6bea2cf-5144-4471-b0db-fff5ccb2171c
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                : 17 November 2016
                : 6 January 2017
                : 14 January 2017
                Funding
                Funded by: Medical Research Council, http://dx.doi.org/10.13039/501100000265;
                Award ID: G0901608
                Categories
                1506
                Clinical
                Original article
                Custom metadata
                unlocked

                Sexual medicine
                clinical sti care,service delivery,diagnosis,bacterial infection,trichomonas
                Sexual medicine
                clinical sti care, service delivery, diagnosis, bacterial infection, trichomonas

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