Cutaneous Leishmaniasis (Diagnosis) Clinical Trial
Official title:
Diagnostic Performance of a Recombinant Polymerase Amplification Test - Lateral Flow (RPA-LF) for Cutaneous Leishmaniasis in an Endemic Setting of Colombia
CL is public health in the Americas, diagnostic confirmation is required to start treatment,
however current diagnostic methods have several limitations and its access is limited.
Technical requirements of conventional molecular diagnostics and costs preclude their routine
use in primary care facilities in rural areas. A recently developed method of Isothermal
Recombinase Polymerase Amplification (RPA) targeting Leishmania kinetoplast DNA, has shown
high accuracy in detecting Leishmania Viannia spp. We evaluated the diagnostic performance of
the RPA-LF test in a laboratory reference center and field scenario with community
participation.
CL is public health in the Americas with an average of 55,000 cases per year between 2001 -
2018 in 17 countries, which mainly occur in rural areas with an average of 55,000 cases per
year between 2001 - 2018 in 17 countries. Diagnostic confirmation is required to start
treatment, however current diagnostic methods have several limitations, and sometimes it is
necessary to perform confirmatory tests that are not available in endemic areas.
Several molecular diagnostic tests have been developed for the diagnosis of CL, however, the
technical requirements and costs of sample processing by conventional or quantitative PCR
preclude their routine use in primary care facilities in resource-constrained settings. A
recently developed method of Isothermal Recombinase Polymerase Amplification (RPA) targeting
Leishmania kinetoplast DNA, coupled with lateral flow (LF) immunochromatographic strip has
shown high accuracy in detecting Leishmania Viannia spp. We evaluated the diagnostic
performance of RPA-LF test in two scenarios: laboratory reference center and field with
community participation.
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