Diagnostic Accuracy of Infection Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia

CompletedOBSERVATIONAL
Enrollment

411

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

February 28, 2022

Study Completion Date

June 1, 2022

Conditions
Pneumonia, Bacterial
Interventions
DIAGNOSTIC_TEST

PCT

"Serum PCT concentration is quantified with an automated sandwich immunoassay ECLIA (Elecsys®, BRAHMS PCT-analyses) on Cobas e801. Calibration (BRAHMS PCT LIA assay) is performed once per reagent lot and no later than 24 h after Cobas e pack has been registered in the instrument. Quality control is performed after each calibration."

DIAGNOSTIC_TEST

suPAR

Serum suPAR was measured using suPARnostic© Turbilatex assay reagents (validated on Cobas© c111) protocol for Cobas© c702 and c502 applying the Multi-Pack cassettes (Roche Diagnostics, Mannheim, Germany). Calibration is performed at least once a month or in connection to a new batch of TurbiLatex reagents, after calibration a quality control is performed.

DIAGNOSTIC_TEST

Standard care

Standard care is the measurement of CRP (C-reactive protein) will be measured with C - reactive protein (CRP4) immunoturbidimetric assay (Tina-quant®, Roche) on Roche/Hitachi cobas© systems c701/702. Calibration is performed (Tina-quant® C - reactive protein IV) once per reagent lot and after 6 months using the same reagent lot. Quality control is required after calibration and according manufacturing instructions.

Trial Locations (1)

Unknown

Hospital of Southern Jutland, Aabenraa

All Listed Sponsors
lead

University of Southern Denmark

OTHER

NCT04652167 - Diagnostic Accuracy of Infection Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia | Biotech Hunter | Biotech Hunter