Immunoenzymatic assay for the diagnosis of American tegumentary leishmaniasis using soluble and membrane‐enriched fractions from infectious Leishmania (Viannia) braziliensis

Abstract

The diagnosis of American tegumentary leishmaniasis (ATL) is based on the visualization or isolation of the parasite, which is a time-consuming and poorly sensitive method. In this study, we evaluated the accuracy and reliability of ELISA for the diagnosis of ATL using soluble (SF) and membrane-enriched (MF) antigen fractions obtained from an infectious strain of Leishmania (Viannia) braziliensis. A total of 152 serum samples investigated at a referral center in Rio de Janeiro, Brazil, between 2005 and 2007 were studied. Each sample was tested twice with each fraction for the calculation of reliability (intraclass coefficient (ICC)). Cut-off values of 0.22 (SF) and 0.33 (MF) were defined. The use of the fractions resulted in good discrimination between patients, with a large area under the curve (P<0.0001), but no difference was observed between the two fractions (P=0.45). Sensitivity was 89.5% for each fraction, specificity was 89.5% for SF and 93.4% for MF, and the positive likelihood ratio was 8.5 for SF and 13.6 for MF. The ICCs were excellent (SF: 0.96 and MF: 0.90). The antigens tested provided precision and accuracy for the diagnosis of ATL, with SF being recommended due to its lower cost and greater practicality.

Clinical and Immunological Analysis of Cutaneous Leishmaniasis before and after Different Treatments

“…ELISA has been used for diagnosis of CL using soluble (SF) and membrane enriched (MF) antigen fractions obtained from Lb. Sensitivity was 89.5% for each fraction, and specificity was 89.5% for SF and 93.4% for MF [34]. Similar results were obtained with VT vaccine insoluble amastigote antigens from four species Lb, Ld, Lv, and Lch.…”

Diagnostic accuracy of Enzyme-Linked Immunosorbent Assays to detect anti-Leishmania antibodies in patients with American Tegumentary Leishmaniasis: a systematic review

“…Our research resulted in 315 manuscripts related to the serology of leishmaniasis by the combined application of descriptors in the databases described above. Only 14 studies remained ( Table 1 ) 20 , 22 , 24 , 25 , 27 , 32 - 40 after applying the eligibility criteria (duplicate texts, articles related to other topics, texts excluded due to review or quality method criteria). The studies evaluated the diagnostic accuracy of different specific and novel antigens.…”

“…ELISAs are useful diagnostic tools for ATL, being fast and relatively affordable. However, their accuracy is variable 20 , 21 . Several studies have selected proteins common to Leishmania species to develop an assay capable of detecting the disease irrespective of the etiological agent species.…”

High performance of an enzyme linked immunosorbent assay for American tegumentary leishmaniasis diagnosis with Leishmania (Viannia) braziliensis amastigotes membrane crude antigens

“…This serological method also resulted more sensible than those proposed for diagnosis of ATL so far. They are mainly based in CA extracts from promastigotes of Leishmania subgenus species, applied in areas where Viannia subgenus is prevalent [28]. Such a good good performance is also reflected in this work by the high negative PV.…”