Evaluation of 5 different tests for Trichomonas vaginalis infection and cost effective planning for clinical implementation B. Nathan 1, J Appiah 2, D. Heron 1, R Brum 1, P Saunders 2, S Alexander 2, T Nichols 2, P Baraitser 1 and C Ison 2 1Department of Sexual Health and HIV Medicine, King’s College Hospital NHS Foundation Trust, London 2, Sexually Transmitted Bacteria Reference Laboratory, Public Health England, London

Trichomonas vaginalis (TV) infection is the most prevalent non viral STI in the world. Mainstay UK diagnosis wet mount microscopy NAAT (Nucleic Acid Amplification Tests) Point of Care Tests (POCT) RATIONALE

Prospective clinical trial to evaluate 5 different tests: In-house RT-PCR NAAT-Aptima TV kit POCT-OSOM Trichomonas Rapid Test Culture- TV in-pouch Microscopy AIM

Camberwell Sexual Health Clinic King’s College Hospital, London 50% of patients Black background High rates of STIs Highest rates of HIV in UK TV 200 cases at the clinic* 6638 cases- Nationally* *Local GUMCAD Data and Annual STI Tables for 2012 Public Health England.

Symptomatic women 3 extra vaginal swabs for study purposes Usual care pathway and treatment as per microscopy on the day Study swabs analysed All staff blinded to results METHODS

RESULTS MICROSCOPYCULTUREOSOMPCRAptima Total No.(246) Total No. Positive

MicroscopyCultureOSOM Real-time PCR Aptima Sensitivity (%) 38% [19, 59] 88% [68, 97] 92% [73, 99] 88% [68, 97] 92% [73, 99] Specificity (%) 100% [98.3,-] 100% [98.3, -] 100% [98.3, -] 99.6% [97.5, 99.99] 99.6% [97.5, 99.99] PPV (%) 100% [66, -] 100% [84, -] 100% [84, -] 96% [77, 99.2] 96% [78, 99.3] NPV (%) 93.7% [89.8, 96.4] 98.7% [96.2, 99.7] 99.1% [96.8, 99.9] 98.7% [96.1, 99.7] 99.1% [96.8, 99.9] RESULTS

The prevalence of TV infection Microscopy 3.66% 2 reference tests as standard 9.75% Missing over 50% of TV in symptomatic women RESULTS

Microscopy Patient reviewed +/- Treatment Patient reviewed +/- Treatment 1 week Results text Return for treatment 1 week Results text Return for treatment Visit Cost£ Visit Cost £ GC/C NAAT GC cultures HIV/Syphilis GC/C NAAT GC cultures HIV/Syphilis CLINIC PATHWAY ADDITIONAL TV POCT GC/C NAAT GC cultures HIV/Syphilis ADDITIONAL TV POCT GC/C NAAT GC cultures HIV/Syphilis Microscopy Patient reviewed +/- Treatment Patient reviewed +/- Treatment Visit Cost £ ADDITIONAL TV PCR GC/C NAAT GC cultures HIV/Syphilis ADDITIONAL TV PCR GC/C NAAT GC cultures HIV/Syphilis Microscopy Patient reviewed +/- Treatment Patient reviewed +/- Treatment 1 week Results text Return for treatment 1 week Results text Return for treatment

COST PLANNING (£) Additional cost PCR £536,287 POCT £132,323 15,000 attendances symptomatic women/year Assuming 8% prevalence 1200 women

COST PLANNING (£) Additional cost Cost of attendance if result is Positive PCR £536,287£46,353 POCT £57,323 n/a Average 15,000 attendances of symptomatic women/year Assuming 8% prevalence 1200 women

COST PLANNING (£) Additional cost Cost of attendance if result is Positive Total Cost of Test and treatment PCR £536,287£46,353 £582,641 POCT £132,323 n/a £132,323 Average 15,000 attendances of symptomatic women/year Assuming 8% prevalence 1200 women Current practice misses over half of these women 30% return: cost of repeat visit for 360 women £108,135

Molecular tests are superior to Wet mount microscopy to diagnose symptomatic TV in women OSOM/NAAT should be considered where there is a high risk of TV infection POCT testing offers additional cost and clinic flow advantages CONCLUSIONS

All patients who participated in the study. Staff at STBRL, Public Health England Staff at Camberwell Sexual Health clinic Gary Alltimes Finance Department, King’s College Hospital Dr Michael Brady, Camberwell Sexual Health Clinic, King’s College Hospital ACKNOWLEDGMENTS