Preparatory work for the future development of scientific opinions on animal health

Abstract

SUMMARYThis final report summarizes the results of two reviews and a scoping study related to Canine leishmaniosis (CanL). Three objectives were addressed in this project. Objective 1 was to summarize relative sensitivity and specificity estimates of assays used to detect infection in dogs with Leishmania infantum in studies of naïve dogs in areas where Leishmania infantum infection is endemic. Objective 2 was to summarize data available to estimate the prevalence of parasitological cure (failure to detect organism) after a 12-month follow-up period in animals treated with meglumine antimoniate, miltefosine, and allopurinol or combinations of these drugs for canine leishmaniosis. Objective 3 was to assess diagnostic test characteristics of PCR assays and serological assays (ELISA or IFAT) from studies that use experimental models of Canine leishmaniosis. The same comprehensive search was used for all objectives. The searches yielded 7,405 records. After duplicates were removed, 3,865 records remained. Of these, 243 were broadly identified as diagnostic test evaluation studies and at the 2 nd level of screening 18 were considered longitudinal studies. The 18 references were then assessed based on the full text and 7 were considered relevant to the review. The assays assessed by these studies were PCR on skin, buffy coat, bone marrow, blood and conjunctiva, and IFAT and ELISA. For objective 2, 40 potentially relevant records were identified as treatment comparison studies. After full-text screening, 13 studies were included in the review. The treatments varied greatly, and few comparative efficacy estimates were provided. No treatment was associated with 100% cure after 180 days follow-up. For objective 3, 513 citations were identified and the full texts of 169 articles were obtained. Sixty-two articles described at least one of the assays requested (PCR, ELISA or IFAT) and 18 articles described the use of a PCR and either ELISA and/or IFAT.

Untitled

“…As these are relative sensitivities, the real sensitivity lays below these values. In the majority of studies, high relative specificities of 100 % were estimated (O'Connor et al, 2015). The evaluation of Leishmania tests by latent class analysis, using two different test principles (serology and PCR) on two populations with high and low prevalence rates, could be helpful in order to obtain more accurate sensitivity and specificity estimates.…”

“…The detailed review protocol is provided in the external technical report provided to EFSA (O'Connor et al, 2015).…”

“…Details on the research protocol and search strategy can be found in the external technical report provided to EFSA (O'Connor, 2015) Of 3 168 references found by the search strategy, 40 were identified as potentially relevant comparative trials of efficacy for one of the interventions of interest after title/abstract screening. Few studies performed a 360-day follow-up period; which was the minimum duration of follow-up agreed before the onset of the review.…”

Scientific Opinion on canine leishmaniosis

“…As very few studies used either the same assay or the same sample as the referent, it was not possible to combine the results of the studies into a summary with measures of sensitivity or specificity (see Table 6 in O'Connor et al, 2015).…”

“…The objective of the systematic review was to review diagnostic test characteristics of PCR assays and serological assays (ELISA or IFAT) from studies that use experimental models of CanL. The detailed review protocol is provided in the external technical report provided to EFSA (O'Connor et al, 2015).…”