Antibodies against the SARS-CoV-2 receptor-binding domain (RBD) of the S1 subunit of the spike protein (IgG-S) (AdviseDx SARS-CoV-2 IgG II; Abbott, Chicago, IL, USA) and SARS-CoV-2 nucleocapsid (IgG-N) (Abbott ARCHITECT® SARS-CoV-2 anti-N IgG; Abbott) were measured at each collection time point. For IgG-S, results > 50 AU/mL (as the cutoff set by the manufacturer) were considered indicative of seropositivity. For surrogate measurement of neutralizing antibody, a threshold of 4160 AU/mL was applied, as this threshold corresponds to a 95% probability of obtaining a positive result from plaque reduction neutralization test (PRNT) for SARS-CoV-2 at 1:250 dilution [14 (link)]. For IgG-N, results above the index value of 1.40 (as the cutoff set by the manufacturer) were considered indicative of seropositivity.
Advisedx sars cov 2 igg 2
Manufactured by Abbott
Sourced in United States, Germany
The AdviseDx SARS-CoV-2 IgG II is a laboratory instrument designed to detect the presence of IgG antibodies against the SARS-CoV-2 virus. It utilizes chemiluminescent microparticle immunoassay (CMIA) technology to provide quantitative measurements of IgG antibody levels.
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5 protocols using advisedx sars cov 2 igg 2
1
SARS-CoV-2 Antibody Detection Protocol
2
Evaluation of SARS-CoV-2 Antibody Assays
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Thirty SARS-CoV-2 antibody positive EDTA plasma, sera, and heparinized plasma samples, and 30 serologically negative samples of each type (based on previous Abbott Architect AdviseDx SARS-CoV-2 IgG II results) were used in this study. The WHO IS for Anti-SARS-CoV-2 Immunoglobulin was purchased from the National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK).
3
Quantitative Assessment of SARS-CoV-2 Antibodies
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We quantitatively measured SARS-CoV-2 IgG antibodies against spike protein in serum with the chemiluminescence enzyme immunoassay (CLEIA) platform (HISCL) manufactured by Sysmex Co. (Kobe, Japan) to assess vaccine-induced antibody response. A concentration of ≥10 SU/ml was considered seropositive (Noda et al., 2021 ). We confirmed that spike IgG antibody titers measured with this assay were highly correlated with those measured with the AdviseDx SARS-CoV-2 IgG II assay (Abbott ARCHITECT®) using data of two centers that measured antibodies with both assays (n = 2961): spearman's rho = 0.96 (95% confidence intervals [CI]: 0.95–0.96) (Supplemental Fig. 1).
We also quantitatively tested SARS-CoV-2 IgG antibodies against nucleocapsid protein with the HISCL platform to assess past exposure of participants to SARS-CoV-2. A concentration of ≥10 SU/ml was considered seropositive. The sensitivity and specificity were 100% and 99.8%, respectively (Noda et al., 2021 ).
We also quantitatively tested SARS-CoV-2 IgG antibodies against nucleocapsid protein with the HISCL platform to assess past exposure of participants to SARS-CoV-2. A concentration of ≥10 SU/ml was considered seropositive. The sensitivity and specificity were 100% and 99.8%, respectively (Noda et al., 2021 ).
4
Quantitative SARS-CoV-2 IgG Assay
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SARS-CoV-2 quantitative IgG levels were determined using the Abbott AdviseDx SARS-CoV-2 IgG II (spike RBD-based) test according to the manufacturer’s specifications.
5
Evaluation of Diagnostic Assays for DBS
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We evaluated the analytical sensitivity, specificity and reproducibility of the ARCHITECT hepatitis B surface antigen (HBsAg) NEXT Qualitative (HBsAgNx; Abbott Ireland, Sligo, Ireland; list 04P76), HBsAg NEXT Confirmatory (Abbott Ireland; list 04P77), hepatitis B e-antigen (HBeAg) Qualitative and Quantitative (Abbott GmbH & Co. KG, Wiesbaden, Germany; list 06C32/07P24), anti-hepatitis B core antigen (anti-HBc II; Abbott GmbH & Co. KG; list 08L44), HIV antigen/antibody (Ag/Ab) Combo (Abbott GmbH & Co. KG; list 04J27) and AdviseDx SARS-CoV-2 IgG II (Abbott Ireland; list 06S60) assays. The performance of each assay was evaluated with or without assay modification to the assay's pipetting algorithm for DBS compared with either the on-market assay performance run with matched plasma samples or the on-market assay performance with serum or plasma as reported in each assay package insert. When required to achieve comparable performance to on-market assays with plasma samples, assay pipetting protocols were modified to use increased sample volumes. Modified assays are considered 'Research Use Only'. DBS sample stability was also assessed for samples run on the HBsAgNx, anti-HBc II and HIV Ag/Ab Combo assays.
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