Review of Two Decades of Cholera Diagnostics – How Far Have We Really Come?
Open Access
- 11 October 2012
- journal article
- review article
- Published by Public Library of Science (PLoS) in PLoS Neglected Tropical Diseases
- Vol. 6 (10), e1845
- https://doi.org/10.1371/journal.pntd.0001845
Abstract
Cholera, an ancient scourge, continues to inflict high rates of mortality today. The rising incidence of epidemics in areas of poor sanitation and crowding highlight the need for better epidemic prevention and early response. Such interventions require the availability of rapid and accurate diagnostic techniques to trigger timely response and mitigate the scale of the outbreak. The current gold standard of bacterial culture is inadequate for rapid diagnosis, highlighting the overarching neglect of field diagnostic needs. This paper was written to support the World Health Organisation's Global Task Force on Cholera Control mandated Cholera and diarrhoeal disease laboratory Network (CholdiNet) in devising a protocol for the validation of Rapid Diagnostic Tests (RDTs) for Vibrio cholerae. The status of diagnostic tools for Vibrio cholerae is assessed, describing products that have been commercialised over the last two decades and discussing their peer-reviewed evaluation. Review of post-1990 peer-reviewed and grey literature on rapid diagnostic tests for Vibrio cholerae. Since 1990, twenty four diagnostic tests have been developed for the detection of Vibrio cholerae in human faecal samples. Fourteen of these have also been described in the literature, with rapid chromatographic-immuno assays (CIA) featuring strongly. Polymerase chain reaction (PCR) assays maintain the ability to detect the lowest amount of bacteria; however CIAs achieve both low detection thresholds and high sensitivity and specificity, making them possible candidates for use in field conditions. Field and laboratory studies were performed in a wide range of settings demonstrating variability in performance, however only a few of these studies were sufficiently stringent, highlighting five RDTs that showed promise in field conditions; COAT, IP cholera dipstick, SMART, IP dipstick and Medicos. In light of non-independent reporting, the authors would like to see these five products undergoing additional studies, with further technical improvements if needed and commercial production. The authors hope that public health use of such a RDT in limited-resource field conditions on stool samples may contribute to effective reduction in cholera epidemic spread. Rising prevalence of cholera outbreaks highlights the need for accurate detection tools. Diagnosing cholera early at the onset of an epidemic, at field level, should allow for a more timely response and a quick containment of the spread and thus a diminished case load. Currently the gold standard to identify the bacteria, Vibrio cholerae, from patient samples remains reliant on lengthy bacterial cultures and an array of biochemical tests. Furthermore, the need for highly-skilled operators and numerous laboratory resources underline the inadequacy of sophisticated tests for use in remote locations. Research to develop more appropriate tools has largely focused on rapid diagnostic tests and attempts to simplify existing technologies. This is yet to deliver evidence-based appropriate tools to address the burden-of-disease cholera inflicts. In light of this neglect we have taken the first step, assessing developments in commercialised diagnostic tools, reviewing previous evaluations undertaken in the literature since 1990. In doing so, we highlight evaluation study parameters that could benefit from stringent standardisation, and identify five tests that show promise for use in field conditions. The authors recommend an indipendent assessment of these products, including technical improvements as required and production to trigger early detection of cholera epidemics.Keywords
This publication has 25 references indexed in Scilit:
- Economic burden of cholera in the WHO African regionBMC International Health and Human Rights, 2009
- Neglected Disease Research and Development: How Much Are We Really Spending?PLoS Medicine, 2009
- Measuring the health impact of human rights violations related to Australian asylum policies and practices: a mixed methods studyBMC International Health and Human Rights, 2009
- Analysis of lolB gene sequence and its use in the development of a PCR assay for the detection of Vibrio choleraeJournal of Microbiological Methods, 2008
- Seasonality of cholera from 1974 to 2005: a review of global patternsInternational Journal of Health Geographics, 2008
- What Works in Fighting Diarrheal Diseases in Developing Countries? A Critical ReviewThe World Bank Research Observer, 2007
- One-Step Immunochromatographic Dipstick Tests for Rapid Detection of Vibrio cholerae O1 and O139 in Stool SamplesClinical and Vaccine Immunology, 2003
- Effects of Global Climate on Infectious Disease: the Cholera ModelClinical Microbiology Reviews, 2002
- Cholera DFA: An improved direct fluorescent monoclonal antibody staining kit for rapid detection and enumeration ofVibrio choleraeO1FEMS Microbiology Letters, 1994
- Specificity of Cholera Screen™ test during an epidemic of cholera-like disease due to Vibrio cholerae O139 synonym BengalTransactions of the Royal Society of Tropical Medicine and Hygiene, 1994