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Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Sponsor: The University of Hong Kong
Summary
Study 1 (S1). In a range of adult patients with sNF and controls, there is no significant difference between the POC-ANC and laboratory analyser. The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample. Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Prospective diagnostic accuracy study. The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
317
Start Date
2027-01-01
Completion Date
2028-03-31
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Hemocue® WBC DIFF system
Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria. Reference counts (Gold standard) will be obtained by a standardised Sysmex XE-5000 automated cell counter (Sysmex Corporation, Kobe, Japan). All samples will be analysed in duplicates on the HemoCue WBC DIFF system and in single replicate on the Sysmex XE-5000 within 8 hours after collection. The timespan between analyses on both systems should be less than 2 hours for each sample.
Locations (1)
Queen Mary Hospital
Hong Kong, Hong Kong