NCT04500873

Performance of RPA-LF for Cutaneous Leishmaniasis

Diagnostic Performance of a Recombinant Polymerase Amplification Test - Lateral Flow (RPA-LF) for Cutaneous Leishmaniasis in an Endemic Setting of Colombia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 128 (actual)
• Sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cutaneous Leishmaniasis (Diagnosis)

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2020-08-05
• Last updated: 2020-08-05

Locations

1 site across 1 country: Colombia