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Evaluation of a novel point-of-care lateral flow assay screening for Neisseria gonorrhoeae infection among pregnant women in Zimbabwe

Article scientifique 2025 Anglais

Résumé

Affordable, easy-to-use and rapid diagnostics may support a move away from syndromic management for sexually transmitted infections (STIs) in resource-constrained settings. A lateral flow assay for Neisseria gonorrhoeae (NG-LFA) has shown high sensitivity and specificity (>90%) in symptomatic individuals. We investigated the performance and acceptability of this assay as a screening tool for NG among pregnant women. This evaluation was embedded within a prospective study evaluating point-of-care STI screening in pregnant women attending antenatal care (ANC) in Harare, Zimbabwe. Participants were included regardless of symptom status, ANC visit number, or gestational age. Nurse-collected vaginal swabs were tested on-site using the NG-LFA and the Xpert CT/NG assay (Xpert) (reference test). The implementation team members (n=4) were interviewed to assess acceptability and usability of NG-LFA. Of 912 participants, 4.8% (44/912) self-reported presence of abnormal vaginal discharge. Xpert NG prevalence was 4.2% (38/912); 81.6% (31/38) of infections were asymptomatic. The sensitivity, specificity, positive predictive value, and negative predictive value (NPV) of the NG-LFA were 65.8% (25/38; 95% CI 48.6%-80.4%), 99.2% (867/874; 95% CI 98.4-99.7%), 78.1% (25/32; 95% CI 60.0-90.7%), and 98.5% (867/880; 95% CI 97.5-99.2%). The NG-LFA was considered easy-to-use and interpret but discordant results led to issues of trust in the NG-LFA results. Among predominantly asymptomatic pregnant women, the NG-LFA had high specificity, but relatively low sensitivity meaning one in three cases of gonorrhoea were not detected. Further studies are warranted to assess the clinical performance and cost-effectiveness of the NG-LFA in other settings and populations.

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Martin, K., Dauya, E., Chikwari, C., Mackworth-Young, C., Simms, V., Bandason, T., Makamure, B., Martin, J., Makoga, F., Machiha, A., Peters, R., Mazzola, L., Blümel, B., Gleeson, B., Marks, M., Kranzer, K., Ferrand, R., Ferreyra, C. (2025). Evaluation of a novel point-of-care lateral flow assay screening for Neisseria gonorrhoeae infection among pregnant women in Zimbabwe. https://doi.org/10.1371/journal.pgph.0003839

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Auteur(s)

Kevin Martin Ethel Dauya Chido Dziva Chikwari Constance Mackworth-Young Victoria Simms Tsitsi Bandason Beauty Makamure Janice R. Martin Forget Makoga Anna Machiha Remco P. H. Peters Laura T Mazzola Benjamin Blümel Birgitta M. Gleeson Michael Marks Katharina Kranzer Rashida A. Ferrand Cecilia Ferreyra

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