Evaluation of a diagnostic device, CL Detect rapid test for the diagnosis of new world cutaneous leishmaniasis in Peru.

ABSTRACT:

Background

Cutaneous leishmaniasis (CL) is a neglected disease and a public health problem in Latin America. The diagnosis of CL in poor hyperendemic regions relies to large extent on the identification of amastigotes in Giemsa-stained smears. There is an urgent need for a rapid, sensitive and low cost diagnostic method for use in field conditions for CL as current modalities are not readily available. The primary objective of this study was to determine the sensitivity and specificity of the FDA-cleared CL Detect Rapid Test in Peru, using modified test procedures rather than the instructions-for-use, by 1) increasing the extraction time and 2) increasing the volume of the sample added to the test strip. CL Detect Rapid Test results were compared against microscopy and kDNA-PCR, fo

SUBMITTER: Grogl M 

PROVIDER: S-EPMC10010545 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature