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IntroductionRapid Point-Of-Care Tests (POCTs) for Chlamydia trachomatis(CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io single module system (Atlas Genetics Ltd) runs clinical samples through a microfluidic CT cartridge, delivering results in 30 min. We evaluated its performance in four RSH clinics.Methods757 females aged >16 provided additional-to-routine self-collected vulvovaginal swab (VVS). Samples were tested fresh on io within 7 days of collection or were frozen at −80°C for later testing. The io CT-assay performance was compared against clinic BD ViperTM Nucleic Acid Amplification Test (NAAT), with discrepant results resolved on the Artus CT/NG assay. The gold standard for discrepants required agreement from 2/3 tests. Factors associated with CT infection were analysed using logistic regression.ResultsInsufficient volume (n=3), missing clinic NAAT data (n=21), and ‘invalid’ (n=24), where io failed to give a result on two successive runs, meant final analyses were conducted on 709 women (94.3%). CT prevalence was 7.2% (51/709). Sensitivity, specificity, positive (PPV) and negative (NPV) predictive values were respectively: 96.1% (95% Confidence Interval (CI): 86.5–99.5), 97.7% (95% CI: 96.3–98.7), 76.6% (95% CI: 64.3–86.2) and 99.7% (95% CI: 98.9–100). There was no significant difference in performance between fresh and frozen samples, or between symptomatic and asymptomatic patients. Risk factors associated with CT infection were sexual contact CT only.ConclusionThe io CT-assay is the only 30 min, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic, to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care.

IntroductionPatient and Public Involvement (PPI) is increasingly seen as necessary for conduct of high-impact ethical research, but when focused on short-term treatable sexually transmitted infections (STIs) it can be challenging to gain participants. The Precise Study is a collaboration to develop and evaluate point of care tests (POCTs) for short-term STI infection and Antimicrobial Resistance (AMR) detection. We explored patient opinions concurrent to POCT development, through qualitative interviews and PPI activities. MethodsQualitative 1-on-1 interviews were conducted with a purposive sample of patients in three sexual health clinics (SHCs) in England. PPI activities included development of a patient and public advisory group (PAG). Interview topics were presented for discussion at one PAG meeting. Members were unaware of qualitative interview results until after they gave their opinions. Findings from qualitative interviews were compared with PAG meeting notes to better understand results of the two approaches. Results31 patient interviews were conducted in SHCs: 11 women, 12 heterosexual men and 8 men who have sex with men. Most patients felt POCTs were preferable to standard care, and many suggested ways to implement the tests in new clinical pathways. Our PAG had 4 members of the public: 3 women and 1 man, all with previous experience in healthcare settings. PAG member opinions of the POCTs and importance of the AMR test mirrored key themes found in patient interviews, however, PAG members focused on the potential for advocacy that POCTs provide, and suggested publicising rapid turnaround of results to encourage testing in high-risk groups with low clinic attendance. ConclusionWe have demonstrated that PPI is possible for stigmatised, treatable short-term STIs, provides new insights into care and utility and allows for continued dialogue on implementing solutions to meet patient concerns. We suggest that where possible, qualitative research is used to iterate the diversity of patient opinions, and is complemented by PPI to build patient-centred solutions.

IntroductionIn sexual health services, availability of rapid and accurate point-of-care tests (POCTs) may enable major improvements in care pathway efficiencies and outcomes. Previous economic evaluations of nucleic acid amplification test (NAAT) POCTs for Chlamydia trachomatis(CT) and Neisseria gonorrhoeae(NG) indicate they may provide a cost-effective strategy for screening genitourinary medicine (GUM) attendees. We estimated costs, benefits and cost-effectiveness of three strategies using accurate, rapid NAAT POCTs that could detect different combinations of common multiple sexually transmitted infections (mSTIs) compared with standard care (SC; laboratory-based CT/NG NAAT).MethodsA decision tree was constructed to simulate a hypothetical cohort of 9 65 988 patients, representing annual numbers of GUM attendees in England, symptomatic for lower genitourinary tract infection. The model considered delivery costs (micro-costing) and reimbursement (tariff) to GUM services associated with diagnosing and managing STIs. POCT strategies compared to SC were: A) POCT for CT and NG; B) POCT for CT-NG and Mycoplasma genitalium(MG); C) POCT for CT-NG-MG and Trichomonas vaginalis. Data came from published literature and unpublished estimates.ResultsSC was cheaper than all POCT strategies when micro-costing, but POCT C was the cheapest strategy for tariff costings. POCT C’s incremental cost-effectiveness ratio (ICER) was £36 585 per quality-adjusted life year (QALY) gained compared to SC when micro-costing; it was cost-saving (by £26,451,382) when tariff costing was applied. POCT C also generated most benefits, with 2 40 467 fewer clinic attendances, 808 fewer onward STI transmissions, and 2 35 135 averted inappropriate treatments compared to SC.ConclusionPOCTs that detect STI diagnoses may be cost-effective, cost-saving and improve patient management. However, there is variation by costing strategy, patient population, clinical setting and patient pathways. Further evidence is needed to populate model parameters to reduce uncertainty in economic analyses.