Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB

Summary

The performance of a new triage test for active tuberculosis (TB), SeroSelectTB, will be qualified in multi-centre randomised controlled trials at health-posts in South Africa, Tanzania and Ethiopia. Cost effectiveness evaluations will be conducted to support a value proposition to stakeholders and regulatory authorities, and to support commercialization requirements.

Consenting adults will provide blood and saliva samples for screening by SeroSelectTB, and sputum collected for routine TB diagnosis by the health services. Clinical and sociodemographic information will be collected.

A reliable rapid test will make it possible to identify and selectively treat those with active TB at the local healthcare level. The expected impact includes accurate same-day diagnosis of patients with active TB, reduction of diagnostic delay and TB transmission, and diagnostic cost-savings for patients and healthcare systems in high TB-burden countries.

Conditions

• Tuberculosis, Pulmonary

Interventions

DIAGNOSTIC_TEST

SeroSelectTB rapid TB test

The SeroSelectTB test is a rapid blood-based immunochemical lateral flow assay for the detection of active tuberculosis.

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• University of Stellenbosch

  collaborator OTHER

• KCMC University, Tanzania

  collaborator UNKNOWN

• Armauer Hansen Research Institute, Ethiopia

  collaborator OTHER

• Lateral Flow Laboratories (Pty) Ltd

  collaborator UNKNOWN

• InVivo BioTech Services GmbH

  collaborator UNKNOWN

• Aether Dynamics Consulting & Trading GmbH

  collaborator UNKNOWN

• E-MEDDIA

  collaborator UNKNOWN

• KNCV Tuberculosis Foundation

  collaborator OTHER

• Norwegian Institute of Public Health

  lead OTHER_GOV

Principal Investigators

• Grant Theron, PhD · University of Stellenbosch

• Balthazar Nyombi, PhD · Kilimanjaro Christian Medical Centre, Tanzania

• Kidist Bobosha, PhD · Armauer Hansen Research Institute

• Carol Holm-Hansen, PhD · Norwegian Institute of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-21

Primary Completion

2025-06-30

Completion

2025-12-31

Countries

• Ethiopia
• South Africa
• Tanzania

Study Locations