NCT03646981

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 704 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 4 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary objective and endpoint: To evaluate the performance of different diagnostic tests in detecting anti-Leishmania antibodies to improve early diagnosis of VL in eastern Africa, in particular Ethiopia, and Kenya. Evaluation of the diagnostic performance of the RDTs for primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests. Design: Prospective single arm diagnostic accuracy study. Multicountry. With participants being suspected cases of VL

Conditions

• Leishmaniasis, Visceral

Interventions

Type	Name	Description
DEVICE	Leishmania Ab Rapid Test (CTK, Biotech)	Rapid diagnostic tests to detect antibodies anti-Leishmania

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-10-30
• Completion: 2021-12-01
• First posted: 2018-08-24
• Last updated: 2022-06-06

Locations

2 sites across 2 countries: Ethiopia, Kenya