Development of a high-throughput SARS-CoV-2 antibody testing pathway using dried blood spot specimens

Background Serological assays for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have roles in seroepidemiology, convalescent plasma-testing, antibody durability and vaccine studies. Currently, SARS-CoV-2 serology is performed using serum/plasma collected by venepuncture. Dried blood s...

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Published in:Annals of clinical biochemistry 2021-03, Vol.58 (2), p.123-131
Main Authors: Moat, Stuart J, Zelek, Wioleta M, Carne, Emily, Ponsford, Mark J, Bramhall, Kathryn, Jones, Sara, El-Shanawany, Tariq, Wise, Matt P, Thomas, Annette, George, Chloe, Fegan, Christopher, Steven, Rachael, Webb, Russell, Weeks, Ian, Morgan, B Paul, Jolles, Stephen
Format: Article
Language:English
Subjects:
Antibodies, Viral - immunology
COVID-19 - diagnosis
COVID-19 - immunology
COVID-19 Serological Testing
Dried Blood Spot Testing
Enzyme-Linked Immunosorbent Assay
Humans
Immunoglobulin G - immunology
SARS-CoV-2 - immunology
Spike Glycoprotein, Coronavirus - immunology
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Summary:Background Serological assays for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have roles in seroepidemiology, convalescent plasma-testing, antibody durability and vaccine studies. Currently, SARS-CoV-2 serology is performed using serum/plasma collected by venepuncture. Dried blood spot (DBS) testing offers significant advantages as it is minimally invasive, avoids venepuncture with specimens being mailed to the laboratory. Methods A pathway utilizing a newborn screening laboratory infrastructure was developed using an enzyme-linked immunosorbent assay to detect IgG antibodies against the receptor-binding domain of the SARS-CoV-2 spike protein in DBS specimens. Paired plasma and DBS specimens from SARS-CoV-2 antibody-positive and -negative subjects and polymerase chain reaction positive subjects were tested. DBS specimen stability, effect of blood volume and punch location were also evaluated. Results DBS specimens from antibody-negative (n = 85) and -positive (n = 35) subjects and polymerase chain reaction positive subjects (n = 11) had a mean (SD; range) optical density (OD) of 0.14 (0.046; 0.03–0.27), 0.98 (0.41; 0.31–1.64) and 1.12 (0.37; 0.49–1.54), respectively. An action value OD >0.28 correctly assigned all cases. The weighted Deming regression for comparison of the DBS and the plasma assay yielded: y = 0.004041 + 1.005x, r = 0.991, Sy/x 0.171, n = 82. Extraction efficiency of antibodies from DBS specimens was >99%. DBS specimens were stable for at least 28 days at ambient room temperature and humidity. Conclusions SARS-CoV-2 IgG receptor-binding domain antibodies can be reliably detected in DBS specimens. DBS serological testing offers lower costs than either point of care or serum/plasma assays that require patient travel, phlebotomy and hospital/clinic resources; the development of a DBS assay may be particularly important for resource poor settings.
ISSN:0004-5632
1758-1001
DOI:10.1177/0004563220981106