Evaluation of the diagnostic performance of the Eazyplex platform for detection of Chlamydia trachomatis and Neisseria gonorrhoeae among women in Zimbabwe.

BACKGROUND

Gaps in sexually transmitted infection (STI) diagnosis hinder effective STI control particularly in low-resource settings where syndromic management is often the standard of care. Rapid and affordable point-of-care (POC) diagnostics for STIs such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are needed. This study evaluated the diagnostic performance of Eazyplex (a point-of-care test (POCT)) to screen CT and NG among sexually active women in Zimbabwe.

METHODS

We enrolled 220 sexually active women aged 18-35 (median 28 years) years attending a family planning clinic in Zimbabwe. Samples collected from vaginal swabs were tested for CT and NG using Eazyplex, GeneXpert and PRESTO CT/NG. Diagnostic performance metrics (sensitivity, specificity, positive predictive value and negative predictive value) were calculated against GeneXpert, PRESTO CT/NG and a GeneXpert+PRESTO CT/NG combined reference standard. For the combined reference standard, a participant was categorised as having a positive result for CT or NG if either of the two tests yielded a positive result.

RESULTS

Overall, Eazyplex reported high specificity and low sensitivity. CT results demonstrated sensitivities of 60.9%, 76.2% and 64.0% compared with GeneXpert, PRESTO CT/NG and GeneXpert+PRESTO CT/NG combined, respectively. NG results demonstrated sensitivities of 57.1%, 66.7% and 66.7% compared with GeneXpert, PRESTO CT/NG and GeneXpert+PRESTO CT/NG combined, respectively. All results had specificity ≥98.5%.

CONCLUSION

Eazyplex was highly specific but moderately sensitive in detecting NG and CT. While not suitable as a standalone screening tool, its rapid turnaround gives it potential for use as near POCT in low-resource settings.