Multi-centric prospective evaluation of rk39 rapid test and direct agglutination test for the diagnosis of visceral leishmaniasis in Brazil.
The diagnosis of visceral leishmaniasis (VL) is still a major problem in Brazil and several other countries where the disease is endemic. The use of an easy-to-use and interpret, sensitive, and specific method that requires no complex infrastructure or specialized professionals, such as direct agglutination test (DAT) and the rK39-based rapid immunochromatographic test may enhance the diagnosis of disease. This study evaluated the performance of a rapid test (DiaMed- IT-LEISH®) and the DAT for the diagnosis of VL in 213 parasitologically confirmed cases and 119 controls with clinical suspicion of VL and confirmation of another etiology. The sensitivities and specificities of the rapid test were 93% and 97%, respectively and those of the DAT were 90% and 96%, respectively. The positive predictive values of the rapid test and the DAT were 98% and 97%, respectively and the negative predictive values were 89% and 84%, respectively. The Kappa index showed agreement between both methods classified as substantial (0.77). This study showed that the DAT and the rapid test can be used to diagnose VL in Brazil, following a pilot study for implementation of the rapid test in the health services.
Laboratório de Pesquisas Clínicas, Centro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Tália S M
TS
de Assis
Alexandre S da C
AS
Braga
Mariana J
MJ
Pedras
Edward
E
Oliveira
Aldina
A
Barral
Isadora C
IC
de Siqueira
Carlos H N
CH
Costa
Dorcas L
DL
Costa
Thiago A
TA
Holanda
Vítor Y R
VY
Soares
Mauro
M
Biá
Arlene de J M
Ade J
Caldas
Gustavo A S
GA
Romero
Ana
A
Rabello
D000372:Agglutination Tests / Q000592:standards*; D000818:Animals; D001938:Brazil / Q000453:epidemiology; D005260:Female; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000175:diagnosis* / Q000453:epidemiology; D008297:Male; D015995:Prevalence; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D012680:Sensitivity and Specificity
D011933:Reagent Kits, Diagnostic