Evaluation of three rapid diagnostic tests for cholera: does the skill level of the technician matter?

Kalluri, P.; Naheed, Aliya; Rahman, Saifur; Ansaruzzaman, M.; Faruque, Abu Syed Golam; Bird, Michele; Khatun, Fatema; Bhuiyan, N. A.; Nato, Farida; Fournier, Jean‐Michel; Bopp, Cheryl A.; Breiman, Robert F.; Nair, G. Balakrish; Mintz, Eric D.

doi:10.1111/j.1365-3156.2005.01539.x

Cited by 45 publications

(60 citation statements)

References 5 publications

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“…A yellow faint or purple band appeared in the prescribed time on the test line of some dipsticks (17 %) tested on S. dysenteriae 1 negative sample. This phenomenon has been also observed for rapid diagnostic tests developed for cholera [55]. In our experience in the DRC, by informing of this phenomenon on the notice instruction, negative results were correctly read by the field technician working in the dispensary of Bunia.…”

Section: Discussionsupporting

confidence: 55%

Dipstick Test for Rapid Diagnosis of Shigella dysenteriae 1 in Bacterial Cultures and Its Potential Use on Stool Samples

et al. 2011

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BackgroundWe describe a test for rapid detection of S. dysenteriae 1 in bacterial cultures and in stools, at the bedside of patients.Methodology/Principal FindingsThe test is based on the detection of S. dysenteriae 1 lipopolysaccharide (LPS) using serotype 1-specific monoclonal antibodies coupled to gold particles and displayed on a one-step immunochromatographic dipstick. A concentration as low as 15 ng/ml of LPS was detected in distilled water and in reconstituted stools in 10 minutes. In distilled water and in reconstituted stools, an unequivocal positive reaction was obtained with 1.6×106 CFU/ml and 4.9×106 CFU/ml of S. dysenteriae 1, respectively. Optimal conditions to read the test have been determined to limit the risk of ambiguous results due to appearance of a faint yellow test band in some negative samples. The specificity was 100% when tested with a battery of Shigella and unrelated strains in culture. When tested on 328 clinical samples in India, Vietnam, Senegal and France by laboratory technicians and in Democratic Republic of Congo by a field technician, the specificity (312/316) was 98.7% (95% CI:96.6–99.6%) and the sensitivity (11/12) was 91.7% (95% CI:59.8–99.6%). Stool cultures and the immunochromatographic test showed concordant results in 98.4 % of cases (323/328) in comparative studies. Positive and negative predictive values were 73.3% (95% CI:44.8–91.1%) and 99.7% (95% CI:98–100%).ConclusionThe initial findings presented here for a simple dipstick-based test to diagnose S. dysenteriae 1 demonstrates its promising potential to become a powerful tool for case management and epidemiological surveys.

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Section: Discussionsupporting

confidence: 55%

Dipstick Test for Rapid Diagnosis of Shigella dysenteriae 1 in Bacterial Cultures and Its Potential Use on Stool Samples

et al. 2011

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“…At the time of writing, the authors could not find any literature reviews of diagnostic tools comparable to the scale of this study. At best, papers describe the comparison in efficacy between three diagnostic tools [14]. Those aforementioned diagnostic evaluations appear to have a number of limitations.…”

Section: Discussionmentioning

confidence: 99%

Review of Two Decades of Cholera Diagnostics – How Far Have We Really Come?

et al. 2012

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BackgroundCholera, 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.MethodReview of post-1990 peer-reviewed and grey literature on rapid diagnostic tests for Vibrio cholerae.ResultsSince 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.

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“…non-specific reactions, which could have been expected considering the reported moderate specificity of the test [4], [11]–[13], or positivity due to asymptomatic carriers. The sharp increase and subsequent decrease in the proportion of O139 positive tests after vaccination are not in favour of such assumptions and suggest that the positive results were due to the vaccine alone.…”

Section: Discussionmentioning

confidence: 99%

“…The RDT is produced by Span Diagnostics (Surat, India) under the trade name Crystal VC [5]. Several evaluations have shown good sensitivity, ranging from 92% to 100% [7], [11]–[12]. In contrast, the specificity was lower and most evaluations in field conditions have shown specificities from 71% to 77% when compared with culture as the gold standard [4], [11]–[13].…”

Section: Introductionmentioning

confidence: 99%

“…Several evaluations have shown good sensitivity, ranging from 92% to 100% [7], [11]–[12]. In contrast, the specificity was lower and most evaluations in field conditions have shown specificities from 71% to 77% when compared with culture as the gold standard [4], [11]–[13]. Nevertheless, the use of culture as gold standard may underestimate specificity, and re-analysis of the data using statistical methods for evaluation with an imperfect gold standard showed that the specificity could be around 85% [14].…”

Section: Introductionmentioning

confidence: 99%

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Use of a Cholera Rapid Diagnostic Test during a Mass Vaccination Campaign in Response to an Epidemic in Guinea, 2012

Martínez-Pino

Luquero²,

Кейта

et al. 2013

PLoS Negl Trop Dis

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BackgroundDuring the 2012 cholera outbreak in the Republic of Guinea, the Ministry of Health, supported by Médecins Sans Frontières - Operational Center Geneva, used the oral cholera vaccine Shanchol as a part of the emergency response. The rapid diagnostic test (RDT) Crystal VC, widely used during outbreaks, detects lipopolysaccharide antigens of Vibrio cholerae O1 and O139, both included in Shanchol. In the context of reactive use of a whole-cell cholera vaccine in a region where cholera cases have been reported, it is essential to know what proportion of vaccinated individuals would be reactive to the RDT and for how long after vaccination.Methodology/Principal FindingsA total of 108 vaccinated individuals, selected systematically among all persons older than one year, were included at vaccination sites and 106 were included in the analysis. Stools samples of this cohort of vaccinated participants were collected and tested with the RDT every day until the test was negative for two consecutive visits or for a maximum of 7 days. A total of 94.3% of cholera vaccine recipients had a positive test after vaccination; all except one of these positive results were reactive only with the O139 antigen. The mean time to become negative in those with an initial positive result after vaccination was 3.8 days, standard deviation 1.1 days.Conclusions/SignificanceThe RDT Crystal VC becomes positive in persons recently vaccinated against cholera, although almost exclusively to the O139 antigen. This reactivity largely disappeared within five days after vaccination. These results suggest that the test can be used normally as soon as 24 hours after vaccination in a context of O1 epidemics, which represent the vast majority of cases, and after a period of five days in areas where V. cholerae O139 is present. The reason why only O139 test line became positive remains to be investigated.

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Evaluation of three rapid diagnostic tests for cholera: does the skill level of the technician matter?

Cited by 45 publications

References 5 publications

Dipstick Test for Rapid Diagnosis of Shigella dysenteriae 1 in Bacterial Cultures and Its Potential Use on Stool Samples

Dipstick Test for Rapid Diagnosis of Shigella dysenteriae 1 in Bacterial Cultures and Its Potential Use on Stool Samples

Review of Two Decades of Cholera Diagnostics – How Far Have We Really Come?

Use of a Cholera Rapid Diagnostic Test during a Mass Vaccination Campaign in Response to an Epidemic in Guinea, 2012

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