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Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa

NCT03646981 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 704

Last updated 2022-06-06

No results posted yet for this study

Summary

According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic tests and poor reporting. The main approach for VL diagnosis involves antibody detection using the rK39 rapid diagnostic test (RDT) and alternatively the direct agglutination test (DAT) to confirm clinically suspected cases. Suspected cases with negative rK39 RDT and/or DAT results are referred to facilities where examination of tissue aspirate (spleen, bone marrow, lymph node) by microscopy is available. Unfortunately, the diagnostic performance of rK39 in eastern Africa is suboptimal, particularly in settings with a high VL/HIV co-infection rate. A recently developed RDT, based on the recombinant antigen rK28, may overcome this problem, with studies reporting better performance than the rK39. However, data are not definitive, as studies comparing rK28 RDTs with rK39 RDT are limited. Another recently developed RDT detects immunoglobulin G1 (IgG1) specific to Leishmania and has shown promising results in the Indian subcontinent. This study aims to undertake a multi-country assessment of the performance of rK28 and IgG1 RDTs, as compared to the currently used rK39 RDT.

Conditions

  • Leishmaniasis, Visceral

Interventions

DEVICE

Leishmania Ab Rapid Test (CTK, Biotech)

Rapid diagnostic tests to detect antibodies anti-Leishmania

Sponsors & Collaborators

  • University of Gondar

    collaborator OTHER

  • Kenya Medical Research Institute

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Drugs for Neglected Diseases

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Israel Cruz, PhD · Find

Eligibility

Min Age
4 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-10-30
Completion
2021-12-01

Countries

  • Ethiopia
  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646981 on ClinicalTrials.gov