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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Method comparison | 400 samples to be compared directly against the reference method. This is to get the bias estimate. |
| |
| Precision | 30 samples will be each split into 10 individual samples to evaluate the precision of the Entia Liberty devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entia Liberty | Device | Home monitoring system |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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No participants will be recruited. Samples used are from excess venous bloods from the Christie haematology laboratory
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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