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Accuracy and reproducibility of a rapid chromatographic immunoassay for the diagnosis of canine visceral leishmaniasis in Brazil.
Trans R Soc Trop Med Hyg. 2014 Sep; 108(9):568-74.TR

Abstract

BACKGROUND

Visceral leishmaniasis is a major public health concern in Brazil and the domestic dog is the main source of infection. In this study, we aimed to evaluate the accuracy and reliability of a rapid chromatographic immunoassay based on a dual-path platform for the diagnosis of canine visceral leishmaniasis (CVL).

METHODS

Sampling consisted of 428 domestic dogs selected from two neighborhoods in the municipality of Fortaleza, Ceara state, Brazil. The reference standard was composed of three parasitological tests and was applied samples from 333 dogs. The rapid test was used to analyse whole blood and serum samples.

RESULTS

Accuracy of the rapid test in whole blood samples through visual reading (n=305), serum samples through electronic reading (n=333) and serum samples through visual reading (n=333), yielded sensitivities of 87.5% (21/24; 95% CI: 66.5 to 96.7), 88% (22/25; 95% CI: 67.5 to 96.8) and 88% (22/25; 95% CI: 67.5 to 96.8), and specificities of 73.3% (206/281; 95% CI: 67.7 to 78.4), 68.2% (210/308; 95% CI: 62.2 to 74.3) and 69.2% (213/308; 95% CI: 63.7 to 74.3), respectively. Agreement between the visual and electronic readings in 428 serum samples were classified as almost perfect (Kappa Index=0.88; 95% CI: 0.83 to 0.93). The positive predictive value of the test using whole blood samples was 21.9% for the 7.9% prevalence detected by the reference standard in the study sample. A sensitivity analysis of the positive predictive value revealed that it remained below 50% in scenarios with a prevalence of up to 20%.

CONCLUSIONS

The similarity of the accuracy values of the rapid test using whole blood or serum samples, together with its reliable performance in sera through visual and electronic reading, suggests that it may contribute as a screening test for routine use under field-conditions. However, future studies need to improve the accuracy of the test so that it can be successfully implemented in public health programs.

Authors+Show Affiliations

Núcleo de Medicina Tropical, Universidade de Brasília, Distrito Federal, Brazil.Instituto de Pesquisas Evandro Chagas, Fundação Instituto Oswaldo Cruz, Rio de Janeiro, Brazil.Núcleo de Medicina Tropical, Universidade de Brasília, Distrito Federal, Brazil Instituto de Avaliação de Tecnologias em Saúde, IATS/INCT/CNPq, Porto Alegre, Rio Grande do Sul, Brazil Fundação de Amparo à Pesquisa do Estado do Amazonas, FAPEAM, Amazonas, Brazil gromero@unb.br.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

25015665

Citation

Schubach, Edvar Y P., et al. "Accuracy and Reproducibility of a Rapid Chromatographic Immunoassay for the Diagnosis of Canine Visceral Leishmaniasis in Brazil." Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 108, no. 9, 2014, pp. 568-74.
Schubach EY, Figueiredo FB, Romero GA. Accuracy and reproducibility of a rapid chromatographic immunoassay for the diagnosis of canine visceral leishmaniasis in Brazil. Trans R Soc Trop Med Hyg. 2014;108(9):568-74.
Schubach, E. Y., Figueiredo, F. B., & Romero, G. A. (2014). Accuracy and reproducibility of a rapid chromatographic immunoassay for the diagnosis of canine visceral leishmaniasis in Brazil. Transactions of the Royal Society of Tropical Medicine and Hygiene, 108(9), 568-74. https://doi.org/10.1093/trstmh/tru109
Schubach EY, Figueiredo FB, Romero GA. Accuracy and Reproducibility of a Rapid Chromatographic Immunoassay for the Diagnosis of Canine Visceral Leishmaniasis in Brazil. Trans R Soc Trop Med Hyg. 2014;108(9):568-74. PubMed PMID: 25015665.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Accuracy and reproducibility of a rapid chromatographic immunoassay for the diagnosis of canine visceral leishmaniasis in Brazil. AU - Schubach,Edvar Y P, AU - Figueiredo,Fabiano B, AU - Romero,Gustavo A S, Y1 - 2014/07/11/ PY - 2014/7/13/entrez PY - 2014/7/13/pubmed PY - 2015/5/13/medline KW - Diagnostic accuracy KW - Dogs KW - Leishmania infantum KW - Rapid tests KW - Serology KW - Visceral leishmaniasis SP - 568 EP - 74 JF - Transactions of the Royal Society of Tropical Medicine and Hygiene JO - Trans R Soc Trop Med Hyg VL - 108 IS - 9 N2 - BACKGROUND: Visceral leishmaniasis is a major public health concern in Brazil and the domestic dog is the main source of infection. In this study, we aimed to evaluate the accuracy and reliability of a rapid chromatographic immunoassay based on a dual-path platform for the diagnosis of canine visceral leishmaniasis (CVL). METHODS: Sampling consisted of 428 domestic dogs selected from two neighborhoods in the municipality of Fortaleza, Ceara state, Brazil. The reference standard was composed of three parasitological tests and was applied samples from 333 dogs. The rapid test was used to analyse whole blood and serum samples. RESULTS: Accuracy of the rapid test in whole blood samples through visual reading (n=305), serum samples through electronic reading (n=333) and serum samples through visual reading (n=333), yielded sensitivities of 87.5% (21/24; 95% CI: 66.5 to 96.7), 88% (22/25; 95% CI: 67.5 to 96.8) and 88% (22/25; 95% CI: 67.5 to 96.8), and specificities of 73.3% (206/281; 95% CI: 67.7 to 78.4), 68.2% (210/308; 95% CI: 62.2 to 74.3) and 69.2% (213/308; 95% CI: 63.7 to 74.3), respectively. Agreement between the visual and electronic readings in 428 serum samples were classified as almost perfect (Kappa Index=0.88; 95% CI: 0.83 to 0.93). The positive predictive value of the test using whole blood samples was 21.9% for the 7.9% prevalence detected by the reference standard in the study sample. A sensitivity analysis of the positive predictive value revealed that it remained below 50% in scenarios with a prevalence of up to 20%. CONCLUSIONS: The similarity of the accuracy values of the rapid test using whole blood or serum samples, together with its reliable performance in sera through visual and electronic reading, suggests that it may contribute as a screening test for routine use under field-conditions. However, future studies need to improve the accuracy of the test so that it can be successfully implemented in public health programs. SN - 1878-3503 UR - https://www.unboundmedicine.com/medline/citation/25015665/Accuracy_and_reproducibility_of_a_rapid_chromatographic_immunoassay_for_the_diagnosis_of_canine_visceral_leishmaniasis_in_Brazil_ L2 - https://academic.oup.com/trstmh/article-lookup/doi/10.1093/trstmh/tru109 DB - PRIME DP - Unbound Medicine ER -