Notice: Users may be experiencing issues with displaying some pages on stanfordhealthcare.org. We are working closely with our technical teams to resolve the issue as quickly as possible. Thank you for your patience.
 

Learn about the flu shot, COVID-19 vaccine, and our masking policy »

Stanford Health Care

Detection of SARS-CoV-2 Antibodies in Immunoglobulin Products. The journal of allergy and clinical immunology. In practice Cousins, K., Sano, K., Lam, B., Roltgen, K., Bhavsar, D., Singh, G., Jeong, S., Aboelregal, N., Ho, H., Boyd, S., Krammer, F., Cunningham-Rundles, C. 2023

Abstract

BACKGROUND: For patients with primary antibody deficiency, the first line of therapy is replacement with immunoglobulin (Ig) products. Prior to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, Ig products did not contain antibodies with specificity for this virus, and there have been limited data on the antibodies present in the Ig products in current use.OBJECTIVE: To quantitatively examine SARS-CoV-2 antibodies in current immunoglobulin products.METHODS: 142 unique lots of 11 different Ig products intended for intravenous (IV) and/or subcutaneous (SC) delivery were examined for IgG binding activities against recombinant SARS-CoV-2 receptor binding domain (RBD), spike, and nucleocapsid proteins (NP) by enzyme-linked immunosorbent assays (ELISA). Additionally, to assess functionality, 48 of these unique lots were assessed for their ability to inhibit the variants SARS-CoV-2 Ancestral, Alpha, Beta, Delta, and Omicron spike binding to angiotensin converting enzyme 2 (ACE2).RESULTS: Significantly increased antibody values were observed for products manufactured after the year 2020 (expiration dates 2023-2024), as compared to Ig products before 2020 (pre-pandemic). Sixty and eighty-five percent of the Ig products with expiration dates of 2023 and 2024 were positive for antibody to SARS-CoV-2 proteins, respectively. AUC values were significantly higher in products with later expiration dates. Later dates of expiration were also strongly correlated with inhibition of ACE2 binding activity, however a decline in inhibition activity was observed with later variants.CONCLUSION: Overall, more recent Ig products (expiration dates: 2023 - 2025) contained significantly higher binding and inhibition activities against SARS-CoV-2 proteins, as compared to earlier, or pre-pandemic products. Normal donor SARS-CoV-2 antibodies are capable of inhibiting ACE2-binding activities and may provide a therapeutic benefit for patients who do not make a robust vaccine response.

View details for DOI 10.1016/j.jaip.2023.05.005

View details for PubMedID 37182564