tetano
Editor, Senior Moderator
Arch Pathol Lab Med
. 2020 Dec 2.
doi: 10.5858/arpa.2020-0713-SA. Online ahead of print.
Remote fingerstick blood collection for SARS-CoV-2 antibody testing
Wilfredo F Garcia-Beltran[SUP] 1 [/SUP], Tyler E Miller[SUP] 1 [/SUP], Grace Kirkpatrick[SUP] 1 [/SUP], Andrea Nixon[SUP] 1 [/SUP], Michael G Astudillo[SUP] 1 [/SUP], Diane Yang[SUP] 1 [/SUP], Lisa M Mahanta[SUP] 2 [/SUP], Mandakolathur Murali[SUP] 3 [/SUP], Anand S Dighe[SUP] 1 [/SUP], Jochen Lennerz[SUP] 1 [/SUP], Julia Thierauf[SUP] 1 [/SUP], Vivek Naranbhai[SUP] 3 [/SUP], A John Iafrate[SUP] 1 [/SUP]
Affiliations
Abstract
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.
. 2020 Dec 2.
doi: 10.5858/arpa.2020-0713-SA. Online ahead of print.
Remote fingerstick blood collection for SARS-CoV-2 antibody testing
Wilfredo F Garcia-Beltran[SUP] 1 [/SUP], Tyler E Miller[SUP] 1 [/SUP], Grace Kirkpatrick[SUP] 1 [/SUP], Andrea Nixon[SUP] 1 [/SUP], Michael G Astudillo[SUP] 1 [/SUP], Diane Yang[SUP] 1 [/SUP], Lisa M Mahanta[SUP] 2 [/SUP], Mandakolathur Murali[SUP] 3 [/SUP], Anand S Dighe[SUP] 1 [/SUP], Jochen Lennerz[SUP] 1 [/SUP], Julia Thierauf[SUP] 1 [/SUP], Vivek Naranbhai[SUP] 3 [/SUP], A John Iafrate[SUP] 1 [/SUP]
Affiliations
- PMID: 33264390
- DOI: 10.5858/arpa.2020-0713-SA
Abstract
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.