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Research

A meta-analysis of the diagnostic performance of the direct agglutination test and rK39 dipstick for visceral leishmaniasis

BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.38917.503056.7C (Published 05 October 2006) Cite this as: BMJ 2006;333:723
  1. François Chappuis, lecturer (francois.chappuis{at}hcuge.ch)1,
  2. Suman Rijal, professor2,
  3. Alonso Soto, investigator3,
  4. Joris Menten, statistician4,
  5. Marleen Boelaert, professor4
  1. 1 Geneva University Hospitals, Travel and Migration Medicine Unit, rue Micheli-du-Crest 24, 1211 Geneva 14, Switzerland
  2. 2 BP Koirala Institute of Health Sciences, Dharan, Nepal
  3. 3 Hospital Nacional Hipolito Unanue, Universidad Peruana Cayetano Heredia, Lima, Peru
  4. 4 Institute of Tropical Medicine, Antwerp, Belgium
  1. Correspondence to: F Chappuis
  • Accepted 11 July 2006

Abstract

Objective To compare the performance of the direct agglutination test and rK39 dipstick for the diagnosis of visceral leishmaniasis.

Data sources Medline, citation tracking, January 1986 to December 2004.

Selection criteria Original studies evaluating the direct agglutination test or the rK39 dipstick with clinical visceral leishmaniasis as target condition; adequate reference classification; and absolute numbers of true positive, true negative, false positive, and false negative observations available or derivable from the data presented.

Results 30 studies evaluating the direct agglutination test and 13 studies evaluating the rK39 dipstick met the inclusion criteria. The combined sensitivity estimates of the direct agglutination test and the rK39 dipstick were 94.8% (95% confidence interval 92.7% to 96.4%) and 93.9% (87.7% to 97.1%), respectively. Sensitivity seemed higher and more homogenous in the studies carried out in South Asia. Specificity estimates were influenced by the type of controls. In phase III studies carried out on patients with clinically suspected disease, the estimated specificity of the direct agglutination test was 85.9% (72.3% to 93.4%) and of the rK39 dipstick was 90.6% (66.8% to 97.9%).

Conclusion The diagnostic performance of the direct agglutination test and the rK39 dipstick for visceral leishmaniasis is good to excellent and seem comparable.

Footnotes

  • Embedded ImageAdditional tables and references w1-w38 are on bmj.com

    We thank Isabelle Roger for her independent review of data extracted from included papers. The study was part of a PhD thesis for FC.

  • Contributors FC and MB wrote the protocol with input from all authors, did the initial search and study selection, data abstraction, and analysis. FC wrote the paper and is the guarantor. SR helped to develop the protocol, contributed to study selection, data analysis and interpretation, and edited the final manuscript. AS and JM reviewed data analysis, did the statistical analysis, and reviewed the manuscript. MB supervised all phases of the study including the writing of the manuscript.

  • Funding None.

  • Competing interests None declared.

  • Ethical approval Not required.

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