Entia Liberty: Accuracy and Precision

Study Overview
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Brief Summary
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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).

Official Title
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Entia Liberty: Analytical Performance Validation - Accuracy and Precision

Conditions
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Cancer

Intervention / Treatment
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* Device: Entia Liberty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Method comparison<br>400 samples to be compared directly against the reference method. This is to get the bias estimate. | Device: Entia Liberty<br>* Home monitoring system<br>|
| Precision<br>30 samples will be each split into 10 individual samples to evaluate the precision of the Entia Liberty devices. | Device: Entia Liberty<br>* Home monitoring system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain the Total Error per parameter from the results of the Entia Liberty device | The dataset from this study will provide evidence to support the device's performance claims. | 3 months | 
| To obtain the linearity per parameter from the results of the Entia Liberty device | The dataset from this study will provide evidence to support the device's performance claims. | 3 months | 
| To obtain the bias per parameter from the results of the Entia Liberty device | The dataset from this study will provide evidence to support the device's performance claims. | 3 months | 
| To obtain the precision per parameter from the results of the Entia Liberty device | The dataset from this study will provide evidence to support the device's performance claims. | 3 months |