(P86-LB) Evaluation of a lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in asymptomatic individuals in South Africa

Background. A rapid and affordable point-of-care (POC) test is a priority for Neisseria gonorrhoeae (NG) control. A recently developed lateral flow assay (LFA) showed excellent diagnostic performance, meeting the WHO/FIND target product profile for a non-molecular POC test in males and females with genital discharge. Performance of the LFA for N. gonorrhoeae screening in asymptomatic individuals is unknown.

Methods. We evaluated the performance of NG LFA at four primary healthcare facilities in East London, South Africa. Adult individuals visiting these facilities were offered STI screening using NG LFA. First-void urine specimens for males and nurse-collected vaginal swabs for females were tested in-facility with the NG LFA and Xpert® CT/NG assay.



Results. We have enrolled 97 males and 80 females without symptoms in this preliminary analysis of 6 weeks recruitment; Xpert® NG prevalence was 2.4% in males and 4.4% in females. NG LFA was positive in 2/2 urine samples and 3/4 vaginal swabs with a positive Xpert® NG result. NG LFA was negative in 81/83 (98%) urine specimens and 61/64 (95%) vaginal swabs with negative Xpert® result. LFA was persistently positive at one week follow-up for 2/3 Xpert NG negative swabs with further microbiological analysis pending.

Conclusion. These preliminary data from an ongoing study suggest high specificity of the LFA for testing asymptomatic individuals for N. gonorrhoeae infection. Sensitivity should be confirmed with ongoing recruitment. Microbiological analysis of potential cross-reactivity and N. gonorrhoeae strain characterization of discordant specimens is underway.