1,400
Participants
Start Date
February 15, 2021
Primary Completion Date
April 5, 2022
Study Completion Date
August 11, 2022
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."
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)"
Butha-Buthe District Hospital, Butha-Buthe
Caluza Clinic, Pietermaritzburg
SolidarMed
OTHER
Human Sciences Research Council
OTHER_GOV
Institute of Tropical Medicine, Belgium
OTHER
Radboud University Medical Center
OTHER
Charite University, Berlin, Germany
OTHER
University Hospital, Basel, Switzerland
OTHER
Foundation for Innovative New Diagnostics, Switzerland
OTHER
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Ministry of Health, Lesotho
OTHER_GOV
Klaus Reither
OTHER