International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2026
Diagnostic accuracy of rapid diagnostic tests for vibrio cholerae serogroups O1 and O139: A systematic review and meta-analysis.
СтатьяМетаанализСистематический обзорНазвание и аннотация: Перевод в очереди
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Yao Xitong, Wang Han, Jiang Kuo, Wang Shengyuan, Li Wenjun, Wang Zhun, Qi Yanfei
Аннотация
OBJECTIVES: To evaluate the diagnostic accuracy of cholera RDTs for Vibrio cholera O1/O139 in field settings and assess performance against the 2024 Global Task Force on Cholera Control (GTFCC) Target Product Profile (TPP).
METHODS: PubMed, Web of Science, Embase and MEDLINE were searched through August 2025 for field studies using culture or PCR as reference standards. Methodological quality was assessed using QUADAS-2. Bivariate random-effects models and multivariable meta-regression were employed for data synthesis and heterogeneity analysis.
RESULTS: Twenty-two studies (46 data points, 20,353 specimens) were included. Pooled sensitivity and specificity were 0.95 (95% CI: 0.93-0.97) and 0.95 (95% CI: 0.91-0.97), respectively, both exceeding the 2024 GTFCC TPP requirements. Dual-target (O1+ O139) RDTs performed significantly worse than single-target assays (P = 0.03). Alkaline peptone water (APW) enrichment significantly reduced sensitivity from 0.96 to 0.94 (P < 0.001) without a significant gain in specificity. Use of PCR as the reference standard yielded a markedly higher diagnostic odds ratio (718) than culture (363), indicating that culture bias underestimates RDT performance.
CONCLUSION: Cholera RDTs meet updated global performance standards. For optimal surveillance, single-target O1 RDTs without enrichment are recommended. Incorporating PCR confirmation in future evaluations will mitigate culture-related bias and better reflect true operational utility.
METHODS: PubMed, Web of Science, Embase and MEDLINE were searched through August 2025 for field studies using culture or PCR as reference standards. Methodological quality was assessed using QUADAS-2. Bivariate random-effects models and multivariable meta-regression were employed for data synthesis and heterogeneity analysis.
RESULTS: Twenty-two studies (46 data points, 20,353 specimens) were included. Pooled sensitivity and specificity were 0.95 (95% CI: 0.93-0.97) and 0.95 (95% CI: 0.91-0.97), respectively, both exceeding the 2024 GTFCC TPP requirements. Dual-target (O1+ O139) RDTs performed significantly worse than single-target assays (P = 0.03). Alkaline peptone water (APW) enrichment significantly reduced sensitivity from 0.96 to 0.94 (P < 0.001) without a significant gain in specificity. Use of PCR as the reference standard yielded a markedly higher diagnostic odds ratio (718) than culture (363), indicating that culture bias underestimates RDT performance.
CONCLUSION: Cholera RDTs meet updated global performance standards. For optimal surveillance, single-target O1 RDTs without enrichment are recommended. Incorporating PCR confirmation in future evaluations will mitigate culture-related bias and better reflect true operational utility.