TPP: For a rapid test for diagnosis of Buruli ulcer at the primary health-care level

A rapid test for diagnosis of Buruli ulcer at the primary health-care level. Used in patients who self-present at health centres, or in active case-finding activities. The test is done after clinical assessment.

Minimum/Acceptable: Confirmation of Buruli ulcer. Preferred/Optimal/Ideal: Confirmation of Buruli ulcer

Minimum/Acceptable: Suspected cases, ulcerated lesions (advanced stages). Preferred/Optimal/Ideal: Suspected cases early and advanced stages.

Minimum/Acceptable: Lesion swab, fine-needle aspirate (FNA). Preferred/Optimal/Ideal: Lesion swab, fine-needle aspirate (FNA).

Minimum/Acceptable: Health Center as lowest setting for implementation. Preferred/Optimal/Ideal: Lowest setting of implementation is the Community, as part of active case-finding campaigns.

Clinical sensitivity:: Minimum/Acceptable: Non-inferior than Ziehl–Neelsen microscopy, > 65% in samples confirmed by PCR. Preferred/Optimal/Ideal: ± 10% of that of PCR, when compared to the assessment of a clinical expert panel. Clinical specificity:: Minimum/Acceptable: >90%. Preferred/Optimal/Ideal: >90%. Time to results:: Minimum/Acceptable: Same day. Preferred/Optimal/Ideal: <20mn.

Stability and storage:: Minimum/Acceptable: >1h for a single-use test after opening the pouch. Preferred/Optimal/Ideal: >2h for a single-use test after opening the pouch.

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