Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)
In this study the Investigators wish to compare 200 finger prick sample (capillary) blood results taken and analysed using the Affinity prototype device to standard of care venous blood samples, taken from the participant on the same day. The blood tests will analyse Full Blood Count (FBC) 200 patients will be recruited in total. 100 will take part in Cohort 1, where a member of the clinical research team will take their blood sample using the Affinity prototype device. The other 100 will take part in Cohort 2, where the participant will self test and take the blood sample themselves. Participants will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use.
Study Type
OBSERVATIONAL
Enrollment
247
Patients will have a blood finger prick sample
The Christie NHS Foundation Trust
Manchester, United Kingdom
To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample)
Measuring Full Blood Count (FBC)
Time frame: 1 year
Assessment and feedback
To measure the number of issues when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2).
Time frame: 1 year
Assessment and feedback
To measure the severity of each issue when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2).
Time frame: 1 year
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