Evaluation to Assess the Usability of rK28 for the Diagnosis of Visceral Leishmaniasis in Kenya

UnknownOBSERVATIONAL
Enrollment

625

Participants

Timeline

Start Date

December 31, 2022

Primary Completion Date

December 31, 2023

Study Completion Date

June 30, 2024

Conditions
Visceral Leishmaniasis
Interventions
DIAGNOSTIC_TEST

rK28

"rK28 RDT (Index): The Leishmania Ab Rapid Test is a rapid immunochromatographic test that uses the recombinant antigen rK28 to detect antibodies against Leishmania species in human serum, plasma, or whole blood samples intended for primary VL diagnosis. It is a Research Use Only product commercialized by CTK Biotech, Inc. (USA).~IT-Leish rK39 RDT: Rapid immunochromatographic test for detection of antibodies against Leishmania species in human serum, plasma, or whole blood samples of utility in the VL diagnosis algorithm. It is a CE marked product commercialized by Bio-Rad (France). This is currently the recommended RDT for VL diagnosis in Kenya.~Kalazar Detect rK39, RDT: Rapid immunochromatographic test for detection of antibodies against Leishmania species in human serum, plasma, or whole blood samples of utility in the VL diagnosis algorithm. It is a CE marked product commercialized by InBios (United States)."

Trial Locations (4)

Unknown

RECRUITING

Turkana County, Lodwar

RECRUITING

Marsabit County, Marsabit

ACTIVE_NOT_RECRUITING

Kenya Medical Research Institute, Nairobi

RECRUITING

Wajir County, Wajir

Sponsors
All Listed Sponsors
collaborator

Kenya Medical Research Institute

OTHER

lead

Foundation for Innovative New Diagnostics, Switzerland

OTHER