Evaluation of conventional serological tests for the diagnosis of American cutaneous Leishmaniasis

Abstract

Three serological tests (ELISA, IFAT, DAT) were evaluated using sera from selected individuals with different American cutaneous leishmaniasis (ACL) clinical conditions. Reactivity in at least 2 of the 3 named tests was established as a criterion for declaring a patient as sero-positive. Prior to serological testing, people were diagnosed by clinical (presence of lesion = pl or scar=Sc), parasitological (presence of parasites =pp), immunological (LST) and molecular (PCR) methods. For a statistical comparison of the evaluated tests 4 groups of people were made up: 1) patients with active leishmanial lesion (n=44; pl, pp, +LST, +PCR); 2) patients who had recovered from leishmanial infection (n=43; Sc, +LST, +PCR); 3) asymptomatic individuals from endemic areas showing evidence of having contacted Leishmania-parasites (n=40; +LST, +PCR) and 4) Leishmania-negative people from the above localities where leishmaniasis is endemic and living under the same risk conditions, considered as healthy controls (n=104; -LST, -PCR). Considering the above-established criteria for sero-positives, the analysis of the results obtained with the 3 tests employed revealed very low sensitivity values. Seropositive figures of 50% were recorded for the first group, 9% for the second group, and 12.5% for the third group. Statistical analysis also revealed a low positive predictive value (PPV=0.73), a low negative predictive value (NPV=0.49), and a low kappa coefficient value (k=0.114). The present results raise questions about the use of the 3 conventional serological tests compared here to detect ACL at any clinical condition.