An interventional study of Hemocue® WBC DIFF system in Suspected Neutropenic Fever, Confirmed Neutropenic Fever and Severe Neutropenic Fever, sponsored by The University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Diagnostic
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).
Questions
In ED and hospitalised adult cancer patients with sNF, is a POC-ANC sufficiently accurate as a diagnostic test compared with a laboratory gold standard?
Primary hypotheses
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.
Definitions
Suspected neutropenic fever (sNF) refers to fever after myelosuppressive cancer treatment in a patient in whom neutropenia is suspected, before laboratory confirmation.
The definition of NF varies across different international guidelines. In this proposal, NF is defined as an ANC \<1.0 × 10⁹/L and fever with a single oral temperature of ≥38.3°C (101°F) or a temperature of ≥38.0°C (100.4°F) sustained over a one-hour period after myelosuppressive cancer treatment in the ED or within 24 hours prior to ED registration. However, some guidelines and oncologists set the definition of NF at \<0.5 × 10⁹/L.
Severe neutropenia is defined as an ANC \<0.5 × 10⁹/L. This NF definition leaves a safety margin with an anticipation that some patients with an initial ANC of 0.5-1.0 × 10⁹/L may progress to severe neutropenia over the next 48 hours.
Thus, sNF patients will be further categorised into severe NF (ANC \<0.5 × 10⁹/L), non-severe NF (ANC 0.5-1.0 × 10⁹/L) and non-NF (ANC ≥1.0 × 10⁹/L) for comparison.
S1. Diagnostic Accuracy
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.
We use methods as previously reported by Russcher [16]. 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.
Justification for evaluating capillary blood
It is important to evaluate the accuracy of capillary blood as the POCANC device might find a use in other settings e.g. clinics, or home use.
Outcomes
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).
Data processing
The primary analysis is on sensitivity of 97 - 99.9% looking to safely rule out NF.
In addition we will evaluate accuracy of the ANC aiming for the slope for linear regression between both test and reference methods no more than ± 5% (r≥0.95).
We will also calculate pooled standard deviations (SD) and coefficient variations (CV). We will report the SD/CV and Bland-Altman Limits of acceptance (LoA) aiming for \<15%. All the data will be analysed using orthogonal regression analysis (Deming regression) and Pearson's correlation coefficient (r).
We will also report intra-and inter-class variation, inter-hospital laboratory variation (where available), specificity, AUC, NPV and PPV.
Missing Data
Patients with missing laboratory or POCT ANC data will be excluded from data analysis. For POCT ANC values below lower limit of detection leading to the absence of a numerical value, pairwise correlation analysis will not be performed. Other missing values will not be imputed.
Ethics approval
This study has been approved by the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB; reference number: UW 25-660).
147 studies on the registry are indexed under Febrile Neutropenia; 36 are open to participants now.
This study's planned enrollment of 317 is above the median of 120 across 95 interventional studies indexed under Febrile Neutropenia.
Browse Febrile Neutropenia studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
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Exclusion Criteria:
S1. Adult patients with suspected low ANC in the ED or admitted to medical wards. 1. ≥18 years; AND 2. Suspected low ANC; AND 3. Stable
Diagnostic Test: 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.
Also known as: POC-ANC, POCT-ANC
sensitivity of POC-ANC compared with the laboratory reference method
The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below). The primary analysis is on sensitivity of 97 - 99.9% looking to safely rule out NF.
Time frame: 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.
Plan to share: Undecided
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