The SAGE IVD recommended inclusion on the EDL of the rapid antigen test for V. cholerae in the detection and monitoring of cholera epidemics at primary care level and for ruling out outbreaks. The Group noted that the test is rapid and easy to use, with acceptable diagnostic accuracy for the purpose. SAGE IVD noted, however, that, in view of its high cost and the variation among studies, studies of its impact would be useful to demonstrate its utility. Recommended test purpose: for early, initial detection or exclusion of a cholera outbreak (not for use in case management).

Cholera outbreaks must be detected and monitored for rapid control. As they often occur in low-resource settings or in emergency situations, diagnostic tests that are simple to use at primary care level must be available. RDTs for cholera have been evaluated in many studies. Current cholera RDTs are intended for use in primary care settings for surveillance. They increase the specificity of the clinical diagnosis of cholera and permit triage of specimens for laboratory confirmation. Cholera RDTs may be used for early outbreak detection, for an initial alert and for monitoring outbreaks and seasonal peaks in highly endemic areas. In areas in which confirmed cholera cases have not recently been reported, positive RDT results for one or more patients with clinically suspected cholera are sufficient to launch a cholera alert, send stool specimens to a reference laboratory for confirmation by culture and initiate response measures (e.g. inform authorities and mobilize resources and material). In areas with ongoing outbreaks, positive RDTs can be used to select stool specimens from suspected cases for culture. Any positive RDT result must be confirmed by culture or PCR as soon as possible before the alert is confirmed and a cholera outbreak declared.

A review of the development and evaluation of cholera diagnostics since 1990 (6) included a systematic search for studies, an analysis of methodological challenges in the studies and limited details of evaluation studies; however, the quality of the studies was not assessed, and a meta-analysis was not undertaken. Many methodological limitations and variations in accuracy among test kits were identified. Five tests were considered promising, with a sensitivity that may exceed 90% and a specificity of about 80%, although there is considerable variation among tests.

World Health Organization. (‎2019)‎. The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (‎including the second WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/329527