To evaluate the diagnostic accuracy of rapid diagnostic tests (RDTs) for *Vibrio cholerae* O1 and O139 in field settings and assess their performance against the 2024 Global Task Force on Cholera Control (GTFCC) target product profile.
Approach:
Systematic review and meta-analysis: Conducted according to PRISMA 2020 guidelines, the review searched PubMed, Embase, Web of Science, and MEDLINE through August 29, 2025. It included 22 field studies comprising 46 data points and 20 353 specimens. Culture or polymerase chain reaction served as reference standards.
Key Findings:
Pooled sensitivity and specificity were both 0.95, exceeding the 2024 GTFCC minimum requirements of at least 90% sensitivity and 85% specificity.
Dual-target O1/O139 RDTs performed significantly worse than single-target tests.
Alkaline peptone water enrichment significantly reduced sensitivity from 0.96 to 0.94 without significantly improving specificity.
The diagnostic odds ratio was higher with polymerase chain reaction than culture as the reference standard, suggesting that culture-based evaluations underestimate RDT performance.
Interpretation:
Current cholera RDTs meet updated global performance standards and can support field surveillance and outbreak response. Single-target O1 tests used directly on stool without enrichment provided the preferred strategy in settings where O1 predominates.
Limitations:
More than half of the included studies were conducted in Africa, potentially limiting geographic generalizability.
Most studies used culture as the reference standard, which has suboptimal sensitivity.
Some studies had risks of bias, and cross-sectional designs could not assess longitudinal operational factors such as lot-to-lot variability or operator-dependent errors.
Conclusion:
Single-target O1 RDTs used without enrichment should be prioritized for surveillance, and future evaluations should incorporate polymerase chain reaction confirmation to reduce culture-related bias.
