TY - JOUR
T1 - Accuracy of cholera rapid diagnostic tests
T2 - a systematic review and meta-analysis
AU - Muzembo, Basilua Andre
AU - Kitahara, Kei
AU - Debnath, Anusuya
AU - Okamoto, Keinosuke
AU - Miyoshi, Shin Ichi
N1 - Funding Information:
This study was supported by the Japan Initiative for Global Research Network on Infectious Diseases (J-GRID), JP20wm0125004, from the Ministry of Education, Culture, Sports, Science & Technology in Japan ( MEXT ), and the Japan Agency for Medical Research and Development ( AMED ). The funders had no role in its study design, data collection and analysis, decision to publish, or preparation of the manuscript. All authors had full access to all the data in the review process, and the corresponding author had the final responsibility in deciding to submit this article for publication.
Publisher Copyright:
© 2021 European Society of Clinical Microbiology and Infectious Diseases
PY - 2021
Y1 - 2021
N2 - Background: Cholera is an acute diarrheal disease caused by Vibrio cholerae O1 or O139. Cholera rapid diagnostic tests (RDTs) are widely used to screen for cholera cases. However, their accuracy has not been systematically reviewed. Objectives: To evaluate the diagnostic accuracy of cholera RDTs. Methods: Systematic review and meta-analysis. Data sources: Medline, EMBASE and Web of science through to November 2020; references of included studies and a technical guidance on cholera RDTs. This review is registered with PROSPERO (CRD42021233124). Study eligibility criteria: Cross-sectional studies comparing the performance of cholera RDTs either to stool culture or PCR. Participants: Individuals with clinically suspected cholera. Data extraction: Two authors independently extracted data and assessed the quality using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) criteria. Results: Eighteen studies were included in the systematic review of which 17 were used for meta-analysis. Crystal VC was the most frequently used RDT (13 studies), followed by Cholkit and Institut Pasteur cholera dipstick (three studies each), SD Bioline (two studies), Artron (one study) and Smart (one study). Using direct testing (n = 12 627 specimens), the bivariate random-effects model yielded a pooled sensitivity and specificity of 91% (95% CI 87%–94%) and 80% (95% CI 74%–84%), respectively. However, through alkaline peptone water (APW) enrichment (n = 3403 specimens), the pooled sensitivity and specificity were 89% (95% CI 79%–95%) and 98% (95% CI 95%–99%), respectively. Conclusion: Cholera RDTs, especially when enriched with APW, have moderate sensitivity and specificity. Although less useful for clinical management, the current generation of RDTs have clear utility for surveillance efforts if used in a principled manner. Enrichment of stool specimens in APW before using cholera RDTs reduces the possibility of obtaining false-positive results, despite the few cholera cases that go undetected. It is noteworthy that APW-enriched cholera RDTs are not necessarily rapid tests, and are not listed in the Global Task Force on Cholera Control/WHO target product profile.
AB - Background: Cholera is an acute diarrheal disease caused by Vibrio cholerae O1 or O139. Cholera rapid diagnostic tests (RDTs) are widely used to screen for cholera cases. However, their accuracy has not been systematically reviewed. Objectives: To evaluate the diagnostic accuracy of cholera RDTs. Methods: Systematic review and meta-analysis. Data sources: Medline, EMBASE and Web of science through to November 2020; references of included studies and a technical guidance on cholera RDTs. This review is registered with PROSPERO (CRD42021233124). Study eligibility criteria: Cross-sectional studies comparing the performance of cholera RDTs either to stool culture or PCR. Participants: Individuals with clinically suspected cholera. Data extraction: Two authors independently extracted data and assessed the quality using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) criteria. Results: Eighteen studies were included in the systematic review of which 17 were used for meta-analysis. Crystal VC was the most frequently used RDT (13 studies), followed by Cholkit and Institut Pasteur cholera dipstick (three studies each), SD Bioline (two studies), Artron (one study) and Smart (one study). Using direct testing (n = 12 627 specimens), the bivariate random-effects model yielded a pooled sensitivity and specificity of 91% (95% CI 87%–94%) and 80% (95% CI 74%–84%), respectively. However, through alkaline peptone water (APW) enrichment (n = 3403 specimens), the pooled sensitivity and specificity were 89% (95% CI 79%–95%) and 98% (95% CI 95%–99%), respectively. Conclusion: Cholera RDTs, especially when enriched with APW, have moderate sensitivity and specificity. Although less useful for clinical management, the current generation of RDTs have clear utility for surveillance efforts if used in a principled manner. Enrichment of stool specimens in APW before using cholera RDTs reduces the possibility of obtaining false-positive results, despite the few cholera cases that go undetected. It is noteworthy that APW-enriched cholera RDTs are not necessarily rapid tests, and are not listed in the Global Task Force on Cholera Control/WHO target product profile.
KW - Accuracy
KW - Cholera
KW - Rapid test
KW - Sensitivity
KW - Specificity
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U2 - 10.1016/j.cmi.2021.08.027
DO - 10.1016/j.cmi.2021.08.027
M3 - Review article
C2 - 34506946
AN - SCOPUS:85116786322
SN - 1198-743X
JO - Clinical Microbiology and Infection
JF - Clinical Microbiology and Infection
ER -
