Entia Liberty: Analytical Performance Validation - Accuracy and Precision
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Entia Ltd
- Enrollment
- 530
- Locations
- 1
- Primary Endpoint
- To obtain the Total Error per parameter from the results of the Entia Liberty device
Study Overview
Brief Summary
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Excess blood flagged by the laboratory meeting our requirements will be tested on the Entia Liberty device and have its results compared against the laboratory results. Samples will also be flagged for precision testing (same blood sample, split into 10 Entia Liberty samples).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years old
- •Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle
- •Blood samples that have been stored in K2-EDTA vacutainers only
- •For Accuracy testing: Samples covering 75% of parameter ranges (Neutrophils: 0.5-7.5 x 109/L, Platelets: 20-450 x 109/L, Haemoglobin: 70-180 g/L), These will be determined by a gold standard analyser which has been recently calibrated.
- •Reliability study: Level range per parameter. These will be determined by a gold standard analyser which has been recently calibrated.
- •Neutrophils (We assume WBC to behave similarly in the same ranges) Low: 0.5-1.2 x 109/L (3 samples), 1.2-2 x 109/L (2 samples) Normal: 2-7 x 109/L (3-4 samples) High: 7-12 x 109/L (1-2 samples)
- •Platelets Low: 50-150 x 109/L (5 samples) Normal: 150-400 x 109/L (3 - 4 samples) High: >400 x 109/L (1-2 samples)
- •Haemoglobin Low: <120 g/L (5 samples) Normal: 120-170 g/L (3 - 4 samples) High: >170 g/L (1-2 samples)
Exclusion Criteria
- •History of haematological malignancy
Outcomes
Primary Outcomes
To obtain the Total Error per parameter from the results of the Entia Liberty device
Time Frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the precision per parameter from the results of the Entia Liberty device
Time Frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the bias per parameter from the results of the Entia Liberty device
Time Frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the linearity per parameter from the results of the Entia Liberty device
Time Frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
Secondary Outcomes
No secondary outcomes reported