Clinical Scorecard: Evaluating the Diagnostic Precision of Rapid Tests for Vibrio cholerae Serogroups O1 and O139: A Systematic Review and Meta-Analysis

At a Glance

Key Highlights

• In 2024, 804 721 cholera cases and 5805 deaths were reported across 33 countries.

• The analysis included 22 studies, 46 data points, and 20 353 specimens.

• Pooled RDT sensitivity and specificity were both 0.95, exceeding the 2024 GTFCC minimum surveillance thresholds.

• Dual-target O1/O139 RDTs performed significantly worse than single-target assays.

• Alkaline peptone water enrichment significantly reduced sensitivity without significantly improving specificity.

Guideline-Based Recommendations

Diagnosis

• Use cholera RDTs to support field surveillance and outbreak detection.

• Prioritize single-target O1 RDTs used directly on stool without enrichment in areas where O1 predominates.

• Confirm index cases when resources permit, and incorporate PCR confirmation into future RDT evaluations to reduce culture-related bias.

• Do not use a negative RDT result alone to definitively rule out a highly suspected case.

Management

• Incorporate RDTs into tiered surveillance systems to support timely contact tracing, isolation, and ring vaccination with oral cholera vaccines.

• Consider dual-serogroup detection where O139 is endemic or represents a reemerging threat.

Monitoring & Follow-up

• Standardize training for RDT result interpretation.

• Monitor RDT performance within tiered surveillance networks and confirm index cases when feasible.

Risks

• Conventional culture may produce false-negative results and underestimate RDT performance.

• Dual-target assays may have more false-positive results than single-target tests.

• RDTs retain a risk of false-negative results and should not be used alone to exclude highly suspected cholera.

Patient & Prescribing Data

The included studies evaluated clinical stool specimens or rectal swabs from patients with suspected cholera. Eligible populations included patients presenting with acute watery diarrhea and specimens collected during outbreak surveillance or epidemiologic investigations.

RDTs offer simple, portable testing with minimal infrastructure requirements. Pooled sensitivity and specificity were 95%, supporting their use for cholera surveillance and outbreak response.

Clinical Best Practices

• Prioritize optimized single-target O1 RDTs in settings where O1 predominates.

• Test stool directly without alkaline peptone water enrichment.

• Embed RDTs within tiered surveillance rather than relying on them as stand-alone rule-out tests.

• Provide standardized training for result interpretation and confirm index cases when resources permit.

• Use PCR confirmation in future evaluations while recognizing that PCR cannot distinguish viable from dead bacteria and may be affected by stool inhibitors.

Related Resources & Content

• Foundation for Innovative New Diagnostics, 2024: Target product profile defining performance requirements for rapid diagnostic tests used in cholera surveillance

• Global Task Force on Cholera Control: Ending Cholera: A Global Roadmap to 2030, a framework for reducing cholera deaths and eliminating the disease as a public-health threat

• World Health Organization: Multicountry cholera outbreak situation report summarizing reported cases and deaths across affected countries

• Preferred Reporting Items for Systematic Reviews and Meta-Analyses, 2020: Reporting guideline followed in the systematic review

• Quality Assessment of Diagnostic Accuracy Studies 2: Tool used to evaluate methodological quality and risk of bias in diagnostic-accuracy studies

• Previous meta-analyses of cholera rapid diagnostic tests: Earlier evaluations of test accuracy for detecting Vibrio cholerae serogroup O1

• Polymerase chain reaction–based cholera detection: Molecular methods for confirming Vibrio cholerae infection in future evaluations of rapid diagnostic tests

• Oral cholera vaccination: Use of surveillance supported by rapid diagnostic testing to guide outbreak response and targeted vaccination strategies