Remote Fingerstick Blood Collection for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibody Testing

Abstract

ABSTACT The rapid worldwide spread of severe acute respiratory system coronavirus 2 (SARSCoV-2) infection has propelled the rapid development of serological tests that can detect anti-SARS-CoV-2 antibodies. These have been used for studying the prevalence and spread of infection in different populations, helping establish a recent diagnosis of coronavirus disease 2019 (COVID-19), and will likely be used to confirm humoral immunity after infection or vaccination. However, nearly all lab-based high-throughput SARS-CoV-2 serological assays require a serum sample from venous blood draw, limiting their applications and scalability. Here, we present a method that enables large scale SARS-CoV-2 serological studies by combining self or office collection of fingerprick blood with a volumetric absorptive microsampling device (Mitra, Neoteryx, LLC) with a high-throughput electrochemiluminescence-based SARS-CoV-2 total antibody assay (Roche Elecsys, Roche Diagnostics, Inc.) that is emergency use authorization (EUA) approved for use on serum samples and widely used by clinical laboratories around the world. We found that the Roche Elecsys assay has a high dynamic range that allows for accurate detection of SARS-CoV-2 antibodies in serum samples diluted 1:20 as well as contrived dried blood extracts. Extracts of dried blood from Mitra devices acquired in a community seroprevalence study showed near identical sensitivity and specificity in detection of SARS-CoV-2 antibodies as compared to neat sera using predefined thresholds for each specimen type. Overall, this study affirms the use of Mitra dried blood collection device with the Roche Elecsys SARS-CoV-2 total antibody assay for remote or at-home testing as well as large-scale community seroprevalence studies.

Development of at-home sample collection logistics for large-scale seroprevalence studies

“…Other studies aiming to conduct similarly remote serology did not assess participant satisfaction and rather focused on seroprevalence or technological performance [16][17][18]. The focus of our study was however, to interrogate the nature of participants' willingness to engage in such study design and their overall experience in order to provide a more comprehensive understanding of the usefulness and role remote serology studies stand to play in infectious disease surveillance.…”

Volumetric Absorptive Microsampling: Its Use in Covid-19 Research and Testing

“…Both sample matrices resulted in an identical seroprevalence of 24%. This was the first time such an assay had been developed on a large commercial analyzer for SARS-CoV-2 serology [ 23 ]. A second group led by A Marchand in France, also developed a similar assay on the same platform [ 24 ].…”

Microsampling: A role to play in Covid‐19 diagnosis, surveillance, treatment and clinical trials

“…An application was developed for self, at‐home collection of finger‐prick blood with a VAMS device (20 μl) using high‐throughput electrochemiluminescence‐based total antibody assay which is emergency use authorization (EUA) approved for use on serum samples. This method enables large scale SARS‐CoV‐2 serological studies around the world and will be useful to detect immune responses to vaccines containing a portion of the spike antigen 66 . The methodology reported validation of DBS as an alternative to conventional sampling using commercially available antibody ELISA assay.…”

“…This method enables large scale SARS-CoV-2 serological studies around the world and will be useful to detect immune responses to vaccines containing a portion of the spike antigen. 66 The methodology reported validation of DBS as an alternative to conventional sampling using commercially available antibody ELISA assay. A strong correlation was obtained between the serum and DBS samples.…”