The development, validation and application of remote blood sample collection in telehealth programmes
Journal of Telemedicine and Telecare 2022
PubMed ID : 35538704
The ability to collect blood samples remotely without the involvement of healthcare professionals is a key element of future telehealth applications. We developed and validated the application of the Drawbridge OneDraw device for use at home for blood sample collection. The device was then applied in a large population-based remote monitoring study to assess changes in SARS-CoV-2 IgG antibody levels.
We tested: (1) feasibility of participants using the device at home without a healthcare professional on the upper arm and thigh sites (2) stability of the dried blood sample collected remotely (3) participant acceptability of the device compared with finger-prick and venous blood samples and the validity of SARS-CoV-2 virus antibody measurement versus venous blood sample (4) application to the Fenland COVID-19 study in which 4023 participants at 3 timepoints across 6 months.
Participant acceptability was high, with a significantly lower median perceived pain score and 76% of participants preferring the OneDraw device over the other blood collection methods. There was high level of agreement in SARS-CoV-2 virus antibody results with venous blood samples in 120 participants (Cohen's kappa 0.68 (95% CI 0.56, 0.83). In the Fenland COVID-19 study, 92% of participants returned a sample at baseline (3702/4023), 89% at 3 months (3492/3918) and 93% at 6 months (3453/3731), with almost all samples received successfully processed (99.9%).
The OneDraw device enables a standardised blood sample collection at home by participants themselves. Due to its ease-of-use and acceptability the OneDraw device is particularly useful in telehealth approaches where multiple samples need to be collected.
The ability to collect a blood sample painlessly from people at home without the need of a healthcare worker visit could transform the way healthcare and health research are conducted. We demonstrated that a new device (OneDraw) could be successfully used by people in their own homes to collect a dried blood spot sample and be posted back using the normal postage system to the laboratory. After demonstrating the method worked, it was used in the Fenland COVID-19 study where 10,647 samples were collected every 3-months in over 3,000 participants to measure whether COVID-19 antibodies were present in the blood. This was used to calculate the proportion of participants who had a past COVID-19 infection, with or without symptoms. A high proportion of participants were able to collect their own blood samples (89-93% at each timepoint) and almost all samples received were successfully processed (99.9%).
The COVID-19 pandemic has rapidly increased the adoption of “telehealth” where people communicate online and via the telephone with their healthcare teams and in health research. However, the gap has been how to collect blood samples remotely. During the early phases of the pandemic when home visits were not possible, the only feasible option was for people to take their own blood sample. This usually involves pricking a finger with a lancet and dropping blood onto special paper or into a blood tube. However, many people find this painful and the sample cannot always be reliably used for analysis due to contamination or insufficient blood sample. This study showed that dried blood spot samples from the OneDraw device produced comparable results for assessing COVID-19 antibodies as standard blood samples taken by a needle in the arm by a trained healthcare worker. Participants also preferred the OneDraw device to the other methods and reported lower pain scores. Due to its ease of use and acceptability, the OneDraw device will be particularly useful for future telehealth applications, for example where people cannot travel to a clinical centre and repeat blood samples may be needed.