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

• DOI: 10.1371/journal.pgph.0003839
• Publication Date: 2025-02-11T18:41:57Z
• Authors: Kevin Martin; Ethel Dauya; Chido Dziva Chikwari; Constance R. S. M...; Victoria Simms; Tsitsi Bandason; Beauty Makamure; Janice Martin; Forget Makoga; Anna Machiha; Remco P. H. Peters; Laura T. Mazzola; Benjamin Blumel; Birgitta Gleeson; Michael Marks; Katharina Kranzer; Rashida A. Ferrand; Cecilia Ferreyra
• Keywords: Neisseria gonorrhoeae; Point-of-Care Testing

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