Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis

Summary

In the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined:

* CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software
* Afinion CRP assay (Alere Afinion, USA), which detects a cytokine induced acute phase protein

CAD4TB and the C-reactive protein assay are two tests with great potential of becoming a triage test for the diagnosis of tuberculosis (TB). These potential triage tests for TB are intended to serve as rule-out tests with a high sensitivity and negative predictive value.

Before impact and cost-effectiveness of new TB triage tests for intensified active case finding can be determined, the diagnostic test accuracy needs to be assessed in comparison to confirmatory reference tests. This accuracy study will define cut-off values for CAD4TB as well as for the Afinion CRP assay to be used in a future cluster-randomised trial on impact and cost-effectiveness of TB triage strategies for intensified active case finding in Lesotho and KwaZulu-Natal, South Africa.

A sub-study (detailed in a separate study protocol), hereafter called AHD-FEASIBILITY, explores the feasibility of implementing a series of point-of-care tests, including the new VISITECT CD4 Advanced Disease Test (Omega Diagnostics, UK) as part of the WHO-recommended advanced HIV Disease care package in the context of community-based HIV/TB campaigns.

Due to the coinciding pandemics and the overlapping symptoms of TB and COVID-19, it is critical to test for SARS-Cov-2 infections in the study population. In addition, this study will contribute to the evaluation of a novel SARS-Cov-2 antigen rapid diagnostic test (from the diagnostic pipeline of FIND) and CAD4COVID, a digital chest x-ray analysis software (Delft Imaging System, NL) in combination with differential white blood cell count.

Conditions

• Pulmonary Tuberculosis
• Tuberculosis Diagnosis
• Covid-19
• HIV

Interventions

DIAGNOSTIC_TEST

Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB

CAD4TB version 6 and 7: Software tool for detecting lung abnormalities in computer tomogram images (pulmonary abnormalities) and frontal chest radiograph images (tuberculosis abnormalities) ; availability is guaranteed by Delft Imaging System; EC 0344 Certificate (vs.6); CE mark pending (vs.7). Will be performed by a registered and qualified radiographer in accordance with national regulations. Afinion AS100 Analyzer and Afinion CRP: In vitro diagnostic to determine the amount of CRP in human whole blood, serum or plasma; CE-mark ; Will be performed by qualified, GCP-trained study personnel.

DIAGNOSTIC_TEST

CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection

CAD4COVID: Non-commercial product. Software tool for detecting pneumonia-related features to be expected in COVID-19 patients; availability is guaranteed by Delft Imaging System; CE certified. Will be performed by a registered and qualified radiographer/health professional in accordance with national regulations. Analysis in combination with differential white blood cell count. SD Biosensor, STANDARDTM Q COVID-19 Ag Test (rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2)

Sponsors & Collaborators

• SolidarMed

  collaborator OTHER

• Human Sciences Research Council

  collaborator OTHER_GOV

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Foundation for Innovative New Diagnostics, Switzerland

  collaborator OTHER

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Ministry of Health, Lesotho

  collaborator OTHER_GOV

• Klaus Reither

  lead OTHER

Principal Investigators

• Klaus Reither, MD, PhD · Swiss Tropical & Public Health Institute

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-15

Primary Completion

2022-04-05

Completion

2022-08-11

Countries

• Lesotho
• South Africa

Study Locations