Abstract

To combat the COVID-19 pandemic, vaccines against SARS-CoV-2 are now given to protect populations worldwide. The level of neutralizing antibodies following the vaccination will evolve with time and vary between individuals. Immunoassays quantifying immunoglobulins against the viral spike (S) protein in serum/plasma have been developed, but the need for venous blood samples could limit the frequency and scale of control in populations. The use of a quantitative dried blood spot (DBS) that can be self-collected would simplify this monitoring. The objective of this study was to determine whether a quantitative DBS device (Capitainer qDBS 10 µL) could be used in combination with an Elecsys anti-SARS-CoV-2 S immunoassay from Roche to follow the development and persistence of anti-S antibodies. This objective was carried out through two clinical studies. The first study investigated 14 volunteers who received two doses of the Comirnaty (Pfizer) vaccine. The levels of anti-S antibodies and the progression over time post-vaccination were studied for three months. The level of produced antibodies varied between subjects, but a similar trend was observed. The anti-S antibodies were highly stimulated by the second dose (×100) and peaked two weeks later. The antibody levels subsequently decreased and three months later were down to 65%. DBS proved to be sufficiently sensitive for use in evaluating the immune status against SARS-CoV-2 over a prolonged time. The second cohort was composed of 200 random patients from a clinical chemistry department in Stockholm. In this cohort, we had no information on previous COVID-19 infections or vaccination. Nevertheless, 87% of the subjects had anti-S immunoglobulins over 0.8 U/mL, and the bias between plasma and DBS proved to be variable, as was also seen in the first vaccination study.

Highlights

  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in 2019 as a new highly infectious virus responsible for coronavirus disease 2019 (COVID-19) and caused a worldwide pandemic, the most severe since the Spanish flu a century ago

  • To evaluate the detection of anti-S antibodies from dried blood spot (DBS) in the volunteers, we first validated the protocol of desorption from the DBS

  • To study the development of the levels of neutralizing antibodies under the vaccination scheme and their post-vaccination changes, a phlebotomist collected a tube of whole blood every 2 weeks from each subject, while the Capitainer qDBS was autocollected following the manufacturer’s instructions after a finger prick every week

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Summary

Introduction

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in 2019 as a new highly infectious virus responsible for coronavirus disease 2019 (COVID-19) and caused a worldwide pandemic, the most severe since the Spanish flu a century ago. Pharmaceutical companies reacted quickly to the rising pandemic, and several vaccines were proposed, clinically tested, and approved for use in the general population within two years. A new kind of vaccine proved to be very efficient against the virus: two mRNA vaccines, Comirnaty (Pfizer/BioNtech) and Spikevax (Moderna) [1,2] With these vaccines, mRNA encoding the SARS-CoV-2 viral spike (S) protein, which plays an essential role in viral infectivity, is introduced into human cells. The duration of protection post-vaccination is still unknown and could depend on the persistence of these neutralizing antibodies

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