Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) Serology in the Vaccination Era and Post Booster Vaccination

31 Pages Posted: 7 Jul 2022

See all articles by Latha Dulipsingh

Latha Dulipsingh

Trinity Health Of New England - Division of Diabetes and Endocrinology

Maxine Lang

Trinity Health Of New England - Division of Diabetes and Endocrinology

Margaret Diffenderfer

Boston Heart Diagnostics Corp. - Division of Laboratory Services

Lisa Cook

Trinity Health Of New England - Division of Diabetes and Endocrinology

Jennifer Puff

Trinity Health Of New England - Division of Diabetes and Endocrinology

Lynn Diaz

Trinity Health Of New England - Division of Diabetes and Endocrinology

Lihong He

Boston Heart Diagnostics Corp. - Division of Laboratory Services

Ernst Schaefer

Boston Heart Diagnostics Corp. - Division of Laboratory Services

Multiple version iconThere are 2 versions of this paper

Abstract

Background: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic has caused over 6 million deaths world-wide. In the pre-vaccination era, we noted a 5·3% SARS-CoV-2 IgG antibody positivity rate in 81,624 subjects.

Methods: Utilizing assays for serum SARS-CoV-2 spike (S) protein antibody (Roche) and neutralizing antibody (Diazyme), both >90% IgG, we measured antibodies in 13,189 subjects in the post-vaccination era, and in 69 subjects before and 60 days after booster vaccination.

Results: In 2021, in 10,267 subjects, 25·0% had negative S protein levels (<0.80 U/L), 24·4% had low positive levels (0.80-250 U/L), and 50·7% had high positive levels (>250 U/L). Median neutralizing antibody levels were 1·16 and 2·06 AU/mL in the low and high positive groups, respectively. In 2022, we evaluated 2,016 subjects where samples were diluted 1:100 if S protein antibody levels were >250 U/L. Median S protein and neutralizing antibody levels were 2,065 U/L (86.3% positivity) and 2·68 AU/mL (68.0% positivity), respectively. Antibody levels were also measured in 69 subjects before and 60 days after receiving SARS-CoV-2 booster vaccinations. Treatment resulted in a 15-fold increase in S protein antibody levels from 1,010 to 17,236 U/L, and a 6-fold increase in neutralizing antibody from 1·51 to 12·51 AU/mL in neutralizing antibody levels, respectively (both P <0.00001), with a wide variability in response.

Conclusions: Our data indicate that by early 2022 86% of subjects had positive SARS-CoV-2 S protein antibody levels, and that these levels and neutralizing antibody levels were increased 15-fold and 6-fold, respectively, 60 days after SARS-Cov-2 booster vaccination.

Note:

Funding Information: This study was supported by funds from Trinity Health Of New England, a not-for-profit healthcare organization and Boston Heart Diagnostics.

Declaration of Interests: The authors declare that they have no competing interests.

Ethics Approval Statement: This type of research is exempted from requirement for human institutional review board (IRB) approval as per exemption 4, as listed at https://grants.nih.gov/policy/ humansubjects.htm and at the open education resource (OER) website for research involving human subjects. This exemption “involves the collection or study of data or specimens if publicly available or recorded such that subjects cannot be identified”. We had this designation and our research reviewed by the Advarra Institutional Review Board (Columbia, MD). They determined that this research met the criteria for exemption from institutional review board review under 45 CFR 46.104(d)” and, therefore, ruled that this research did not require IRB approval.

Keywords: SARS-CoV 2, Pre booster and post booster serology, S Protein Antibodies, Neutralizing Antibodies

Suggested Citation

Dulipsingh, Latha and Lang, Maxine and Diffenderfer, Margaret and Cook, Lisa and Puff, Jennifer and Diaz, Lynn and He, Lihong and Schaefer, Ernst J, Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) Serology in the Vaccination Era and Post Booster Vaccination. Available at SSRN: https://ssrn.com/abstract=4156654 or http://dx.doi.org/10.2139/ssrn.4156654

Latha Dulipsingh (Contact Author)

Trinity Health Of New England - Division of Diabetes and Endocrinology ( email )

United Kingdom

Maxine Lang

Trinity Health Of New England - Division of Diabetes and Endocrinology ( email )

Margaret Diffenderfer

Boston Heart Diagnostics Corp. - Division of Laboratory Services ( email )

Lisa Cook

Trinity Health Of New England - Division of Diabetes and Endocrinology ( email )

Jennifer Puff

Trinity Health Of New England - Division of Diabetes and Endocrinology ( email )

Lynn Diaz

Trinity Health Of New England - Division of Diabetes and Endocrinology ( email )

Lihong He

Boston Heart Diagnostics Corp. - Division of Laboratory Services ( email )

Ernst J Schaefer

Boston Heart Diagnostics Corp. - Division of Laboratory Services ( email )

United States

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