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Peer-reviewed veterinary case report

Evaluation of rK39 rapid diagnostic tests for canine visceral leishmaniasis: longitudinal study and meta-analysis.

Journal:
PLoS neglected tropical diseases
Year:
2013
Authors:
Quinnell, Rupert J et al.
Affiliation:
School of Biology · United Kingdom
Species:
dog

Plain-English summary

This study looked at a rapid test called rK39 that helps diagnose canine visceral leishmaniasis, a serious disease in dogs caused by a parasite. Researchers tested 54 dogs in Brazil over nearly two and a half years to see how well the test worked in identifying infected dogs and those showing symptoms. They found that the test was fairly good at confirming disease in dogs that were already showing signs, but it wasn't very effective at detecting infection in dogs that didn't yet show symptoms. Overall, while the rK39 test can help in certain situations, it may not be reliable enough for widespread use in tracking the disease.

Abstract

BACKGROUND: There is a need for sensitive and specific rapid diagnostic tests (RDT) for canine visceral leishmaniasis. The aims of this study were to evaluate the diagnostic performance of immunochromatographic dipstick RDTs using rK39 antigen for canine visceral leishmaniasis by (i) investigating the sensitivity of RDTs to detect infection, disease and infectiousness in a longitudinal cohort study of natural infection in Brazil, and (ii) using meta-analysis to estimate the sensitivity and specificity of RDTs from published studies. METHODOLOGY: We used a rK39 RDT (Kalazar Detect Canine Rapid Test; Inbios) to test sera collected from 54 sentinel dogs exposed to natural infection in an endemic area of Brazil. Dogs were sampled bimonthly for up to 27 months, and rK39 results compared to those of crude antigen ELISA, PCR, clinical status and infectiousness to sandflies. We then searched MEDLINE and Web of Knowledge (1993-2011) for original studies evaluating the performance of rK39 RDTs in dogs. Meta-analysis of sensitivity and specificity was performed using bivariate mixed effects models. PRINCIPAL FINDINGS: The sensitivity of the rK39 RDT in Brazil to detect infection, disease and infectiousness was 46%, 77% and 78% respectively. Sensitivity increased with time since infection, antibody titre, parasite load, clinical score and infectiousness. Sixteen studies met the inclusion criteria for meta-analysis. The combined sensitivity of rK39 RDTs was 86.7% (95% CI: 76.9-92.8%) to detect clinical disease and 59.3% (37.9-77.6%) to detect infection. Combined specificity was 98.7% (89.5-99.9%). Both sensitivity and specificity varied considerably between studies. CONCLUSION: The diagnostic performance of rK39 RDTs is reasonable for confirmation of infection in suspected clinical cases, but the sensitivity to detect infected dogs is too low for large-scale epidemiological studies and operational control programmes.

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Original publication: https://pubmed.ncbi.nlm.nih.gov/23326615/