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

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.

Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting

“…In addition, we were unable to fi nd any studies in the literature designed specifi cally to address rK39 RDT accuracy among HIV-infected patients. A study in Ethiopia, a country with a high HIV prevalence, reported an RDT sensitivity of 77% for HIV-positive patients, which was lower than that observed for HIV-negative patients (87%), but this difference was not statistically signifi cant 15 . In addition, a recent meta-analysis of diagnostics tests for VL in HIV-infected patients did not include the rK39 RDT due to the lack of previously published studies 29 .…”

“…The sensitivity of the rK39 RDT has been reported to vary between 37 and 100%, and the specifi city was estimated between 59 and 100% among immunocompetent patients in endemic regions [9][10][11][12][13][14][15][16] . In addition, a meta-analysis of 13 studies reported an overall sensitivity and specifi city of 93.9% and 90.6%, respectively 15 .…”

“…The sensitivity of the rK39 RDT has been reported to vary between 37 and 100%, and the specifi city was estimated between 59 and 100% among immunocompetent patients in endemic regions [9][10][11][12][13][14][15][16] . In addition, a meta-analysis of 13 studies reported an overall sensitivity and specifi city of 93.9% and 90.6%, respectively 15 . In Brazil, estimates of the sensitivity and specifi city of RDTs vary between 85.7 and 100% and 82.0 and 100%, respectively [17][18][19][20][21] , but few studies have been conducted in real-world scenarios.…”

Herramientas no invasivas en Venezuela: comparación entre las pruebas inmunoserológicas DAT, rK26 y rK39 en el diagnóstico de leishmaniasis visceral

“…Los elevados valores de sensibilidad y especificidad de la aglutinación directa son coherentes con reportes previos, en los que esta prueba ha demostrado ser una técnica valiosa para los estudios de campo (12,13,29,30). La mayor falta de especificidad de esta prueba se obtuvo con sueros de pacientes con leishmaniasis cutánea difusa, lo cual ha sido reportado previamente (12).…”

Hemophagocytic Lymphohistiocytosis Associated with Visceral Leishmaniasis: Varied Presentation

“…Thus, serological diagnosis might be helpful in making earlier diagnosis of VL. The rapid diagnostic test (rk39) has 97 % sensitivity and 98.9 % specificity, good prognostic value as well as earlier sero-conversion [12,13]. It can be a valuable serologic tool complimenting parasitological diagnosis.…”