Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis

Summary

This study evaluates and compares the diagnostic specificity of 5 serological field tests for screening of the population at risk for human African trypanosomiasis due to Trypanosoma brucei gambiense.

Conditions

• Human African Trypanosomiasis
• Sleeping Sickness
• Trypanosoma Brucei Gambiense; Infection
• West African Sleeping Sickness

Interventions

DIAGNOSTIC_TEST

Serological field test for HAT

Whole blood is tested by lateral flow or agglutination (CATT) for the presence of trypanosome specific antibody. Participants testing positive for at least one of these tests will undergo microscopic examination to detect trypanosomes (lymph, mAECT on blood) and DBS will be prepared for immunological and molecular laboratory testing.

DIAGNOSTIC_TEST

malaria rapid test

RDT detecting HRP2 plasmodium antigen.

DIAGNOSTIC_TEST

Immunologic laboratory tests

Laboratory tests detecting trypanosoma brucei gambiense specific (VSG) antibodies in DBS. These tests will only be carried out on participants that are positive in at least on of the rapid serological tests

DIAGNOSTIC_TEST

Molecular laboratory tests

Laboratory tests detecting Trypanozoon specific nucleic acids. These tests will only be carried out on participants that are positive in at least on of the rapid serological tests

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics

  collaborator UNKNOWN

• Programme National de lutte contre la THA, Guinée

  collaborator UNKNOWN

• Université Jean Lorougnon Guédé, Daloa

  collaborator UNKNOWN

• Institut Pasteur, Guinée

  collaborator UNKNOWN

• Institut Pierre Richet, Guinée

  collaborator UNKNOWN

• Institut de Recherche pour le Developpement

  lead OTHER_GOV

Principal Investigators

• Martial N'Djetchi Kassi · Université Jean Lorougnon Guédé de Daloa

• Oumou Camara · Programme National de lutte contre de la THA en Guinée

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-20

Primary Completion

2022-08-31

Completion

2023-08-31

Countries

• Côte d’Ivoire
• Guinea

Study Locations