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

CompletedOBSERVATIONAL
Enrollment

1,400

Participants

Timeline

Start Date

February 15, 2021

Primary Completion Date

April 5, 2022

Study Completion Date

August 11, 2022

Conditions
Pulmonary TuberculosisTuberculosis DiagnosisCovid-19HIV
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)"

Trial Locations (2)

Unknown

Butha-Buthe District Hospital, Butha-Buthe

Caluza Clinic, Pietermaritzburg

All Listed Sponsors
collaborator

SolidarMed

OTHER

collaborator

Human Sciences Research Council

OTHER_GOV

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

Radboud University Medical Center

OTHER

collaborator

Charite University, Berlin, Germany

OTHER

collaborator

University Hospital, Basel, Switzerland

OTHER

collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

collaborator

Ministry of Health, Lesotho

OTHER_GOV

lead

Klaus Reither

OTHER

NCT04666311 - Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis | Biotech Hunter | Biotech Hunter