This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.
Study Type
OBSERVATIONAL
Enrollment
150
Home monitoring device
The Christie NHS Foundation Trust
Manchester, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
To obtain/validate the value of the total error of the Entia Liberty device.
The dataset from this study will provide evidence to support the device's performance claims.
Time frame: 3 months
To obtain/validate the value of the linearity of the Entia Liberty device.
The dataset from this study will provide evidence to support the device's performance claims.
Time frame: 3 months
To obtain/validate the value of the bias of the Entia Liberty device.
The dataset from this study will provide evidence to support the device's performance claims.
Time frame: 3 months
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