The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.

Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy, requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be used in the field has been developed and validated in several countries where other Leishmania species are present. Less invasive tape sampling has also become available. Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear.

The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR) and alternative sample collection methods will be tested in CL suspected individuals in North-West Ethiopia in a cross-sectional study.

Inclusion Criteria:

- Clinical suspicion of CL

Exclusion Criteria:

• ≤ 2 years of age
• Not willing or able to provide consent/assent
• CL presentation with only lesions for which skin slit samples cannot be obtained (e.g. eyelids)
• Co-morbidity with visceral leishmaniasis
• On CL treatment at time of enrollment

Patients presenting at the LRTC with clinically suspected CL during the study period will be screened for eligibility. Suspicion for CL is assessed by physicians as per routine care. In general, children are included in the study population since they are commonly affected, and also make up the majority of DCL patients. Very young children below the age of two are excluded as was done in other studies18 since the study does require more potentially painful procedures as compared to the routine diagnostic procedures.

IPD accessible by managed access

After completion of the primary publication

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