The rapid spread of coronavirus disease 2019 (COVID-19) is an unprecedented global public health emergency. There is an urgent need for accurate epidemiological data to understand how to mitigate the pandemic and support decision-making over the coming months.
The proportion of the population who have had COVID-19 and who are thus likely to be immune to re-infection is unknown, but it is important to quantify this as part of the pandemic management. Social distancing measures and new ways of working means that new methods of blood sample collection are urgently needed for studies. Previously in studies conducted by MRC Epidemiology Unit we would have asked participants to attend a clinical visit at one of the Unit field sites, but in the current climate this is not feasible.
We are starting a large-scale surveillance study in the Fenland cohort to determine the prevalence of previous infection with COVID-19 with repeated measures over a 6-month period to ascertain changes in infection during the study period. For this large-scale study it is important we can obtain adequate blood samples from participants using the dried blood spot (DBS) method that can be standardised as far as possible to undertake the COVID-19 serological testing repeatedly. Finger pricks and lancets are the standard for collecting DBS, but are messy, involve use of an unprotected needle, and can be painful. This can substantially reduce the participant compliance with the blood sampling, particularly when repeated measures are required.
We propose to use a novel and clinically relevant device called OneDraw (Drawbridge Health; www.drawbridgehealth.com) for remote blood sample acquisition from participants in a standardised manner. The advantages of the device are the ability for participants to provide a sample without needing to visit a clinical setting or be visited at home by a healthcare professional, in a minimally invasive, minimal blood volume, and less painful way, which is likely to translate to better compliance with the sampling. In Drawbridge clinical studies, participants rated the OneDraw device to be less painful compared with finger-prick blood collection performed on them using a lancet using a pain rating score of 0-10 (OneDraw mean 1.02 versus Fingerstick mean 2.60 in 260 participants) and 80% preferred using the device compared with finger-prick (12%) and venepuncture (8%) respectively. This makes it a desirable choice for use in a population-based study with repeated blood collection measures.
OneDraw is a CE marked device currently licenced for use by a healthcare professional for HbA1c testing where it has shown excellent inter-operator and lot-to-lot precision (mean CV 1.2% (range 0.1-4.8%); 1.1% (range 0%-3.6%); respectively). We have been granted a dispensation by the MHRA for a limited change from the CE licenced use to use of this device at home by non-healthcare professional participants for blood sampling. We are currently conducting studies to validate the use of the DBS stabilisation matrices used in the device for COVID-19 serological testing against routine venous blood samples in COVID-19 positive patients within Cambridge University Hospital Trust to ensure it is fit for purpose. A second stage of this work is to validate that the DBS sample from the OneDraw using the remote collection protocol is comparable to serology test results using samples from venepuncture, finger-prick and OneDraw undertaken by a trained field team member.
We are conducting this feasibility study to test the OneDraw device for use for COVID-19 antibody tests and for future other Covid-19 relevant biomarkers.
This feasibility study has the following objectives:
- To determine if the OneDraw device can be used to obtain a standardised and adequate dried blood spot sample from the upper arm and thigh by a non-healthcare practitioner (HCP)
- To obtain participant feedback on the instructions for use and ease of use for the OneDraw device
- To assess whether the dried blood sample collected in the OneDraw device by a non-HCP and posted back to the laboratory is stable and adequate for analysis compared with a sample collected in the OneDraw device by an HCP in standardised conditions
- To determine whether the dried blood sample collected in the OneDraw device provides the same antibody test result to a venous blood draw sample and fingerprick dried blood spot sample collected in the OneDraw device by a field team member in standardised conditions