Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Clinical and Analytical Performance of ELISA Salivary Serologic Assay to Detect SARS-CoV-2 IgG in Children and Adults

Andrea Padoan
,
Chiara Cosma
,
Costanza Di Chiara
ORCID logo ,
Giulia Furlan
,
Stefano Gastaldo
,
Ilaria Talli
* ORCID logo ,
Daniele Donà
ORCID logo ,
Daniela Basso
ORCID logo ,
Carlo Giaquinto
,
Mario Plebani
ORCID logo
Version 1 : Received: 16 November 2023 / Approved: 24 November 2023 / Online: 24 November 2023 (05:37:48 CET)

A peer-reviewed article of this Preprint also exists.

Padoan, A.; Cosma, C.; Di Chiara, C.; Furlan, G.; Gastaldo, S.; Talli, I.; Donà, D.; Basso, D.; Giaquinto, C.; Plebani, M. Clinical and Analytical Performance of ELISA Salivary Serologic Assay to Detect SARS-CoV-2 IgG in Children and Adults. Antibodies 2024, 13, 6. Padoan, A.; Cosma, C.; Di Chiara, C.; Furlan, G.; Gastaldo, S.; Talli, I.; Donà, D.; Basso, D.; Giaquinto, C.; Plebani, M. Clinical and Analytical Performance of ELISA Salivary Serologic Assay to Detect SARS-CoV-2 IgG in Children and Adults. Antibodies 2024, 13, 6.

Abstract

Saliva is a promising matrix with several purposes. Our aim is to verify if salivary anti-SARS-CoV-2 antibody determination is suitable for monitoring immune response. One-hundred eighty-seven subjects were enrolled at University-Hospital Padova: 105 females (56.1%) and 82 males (43.9%), 95 (50.8%) children and 92 (49.2%) adults. Subjects self-collected saliva using Salivette; nineteen subjects collected three different samples within the day. A serum sample was obtained for all individuals. The N/S anti-SARS-CoV-2 salivary IgG (sal-IgG) and serum anti-SARS-CoV-2 S-RBD IgG (ser-IgG) were used for determining anti-SARS-CoV-2 antibodies. The mean (min-max) of age was 9.0 (1–18) for children and 42.5 (20–61) for adults. Of 187 samples, 63 were negative for sal-IgG (33.7%), while 7 were negative for ser-IgG (3.7%). Spearman’s correlation was 0.56 (p<0.001). Sal-IgG and ser-IgG levels were correlated with age, but not with gender, comorbidities, prolonged therapy, previous SARS-CoV-2 infection or time from last COVID-19 infection/vaccination. The repeatability ranged from 23.8% (7.4kAU/L) to 4.0% (3.77kAU/L). Linearity of the assay missed in 4/6 samples. No significant intra-subject differences were observed in sal-IgG across samples collected at different time points. Sal-IgG have a good agreement with ser-IgG. Non-invasive saliva collection represents an alternative method for antibody measurement, especially in children.

Keywords

SARS-CoV-2 antibodies, ELISA, salivary samples, children, adults

Subject

Medicine and Pharmacology, Epidemiology and Infectious Diseases

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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