Abstract
Anti-Leishmania antibodies may be detectable in patients with leishmaniasis. Here, we compared a commercial enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Leishmania antibodies, with an immunofluorescence antibody test (IFAT) that is no longer commercially available. Eighty-six serum samples from 73 patients were tested. The results obtained by the NovaLisa™ Leishmania infantum IgG ELISA, interpreted according to the instructions of the manufacturer, but with a modified cut-off for borderline positive values, were compared with the IFAT results that were already available. Moreover, Leishmania Western blot IgG results were available for 43 of the samples. The overall concordance of ELISA and IFAT was 67%. The ELISA and IFAT tests scored as 24% and 15% of the samples being positive, respectively, while 13% and 33% scored as borderline-positive, respectively. Using a Western blot (WB) as the reference, the sensitivities and specificities for the positive plus borderline-positive samples combined was 95.5% (95% confidence interval (CI), 77.2–99.9%) and 81.0% (95% CI, 58.1–94.6%) for ELISA, and 95.5% (95% CI, 77.2–99.9%) and 42.9% (95% CI, 21.8–66.0%) for IFAT, respectively. Overall, the ELISA proved to be a cost-effective alternative to the IFAT, due to its higher accuracy and specificity, and with a consequently lower number of confirmatory WB tests being required. Lastly, we also present data on the associations between seroconversion and the type of leishmaniasis.
Highlights
Leishmaniasis occurs endemically in more than 90 countries [1]
Serum Institut, Copenhagen, comprising 313 blood/biopsy samples from 262 patients tested by real-time polymerase chain reaction (PCR), and 1413 serum samples from 1320 patients tested for anti-Leishmania antibodies by an immunofluorescence antibody test (IFAT)
Anti-Leishmania Antibody Test Results (IFAT) and Leishmania Species-Specific PCR Results According to Sample Localization
Summary
Leishmaniasis occurs endemically in more than 90 countries [1]. The main clinical manifestations include visceral and cutaneous leishmaniasis. Laboratory diagnosis of leishmaniasis relies mainly on direct (microscopy or DNA-based detection) and indirect (serology) detection. A commercially available serological test, the immunofluorescence antibody test (IFAT, Leishmania-spot IF; bioMérieux, Marcy l’Etoile, France) was available for the detection of anti-Leishmania antibodies; this test, is no longer available for purchase. We set out to evaluate a commercial enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Leishmania antibodies, using the IFAT and Western blot as reference methods. A secondary goal aimed to identify the associations between antibody responses detectable by the IFAT (seroconversion) and the infecting species, as confirmed by polymerase chain reaction (PCR) and sequencing in those patients, for whom results from both serological and DNA-based tests were available
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