TY - JOUR
TI - Comparison of a rapid fluorescence immunochromatographic test with an enzyme-linked immunosorbent assay for measurement of SARS-CoV-2 spike protein antibody neutralizing activity
AU - Filippatos, F.
AU - Tatsi, E.-B.
AU - Papagiannopoulos, C.
AU - Syriopoulou, V.
AU - Michos, A.
JO - Journal of Virological Methods
PY - 2023
VL - 316
TODO - null
SP - null
PB - Elsevier B.V.
SN - 0166-0934
TODO - 10.1016/j.jviromet.2023.114728
TODO - tozinameran;  bnt 162 vaccine;  coronavirus spike glycoprotein;  neutralizing antibody;  spike protein, SARS-CoV-2;  virus antibody, adult;  age distribution;  aged;  area under the curve;  Article;  bootstrapping;  centrifugation;  cohort analysis;  comparative study;  controlled study;  coronavirus disease 2019;  correlation coefficient;  drug efficacy;  drug safety;  enzyme linked immunosorbent assay;  female;  fluorescence;  health care personnel;  human;  immunization;  immunoaffinity chromatography;  major clinical study;  male;  middle aged;  optical density;  qualitative analysis;  quantitative analysis;  receiver operating characteristic;  young adult;  coronavirus disease 2019;  enzyme linked immunosorbent assay;  Severe acute respiratory syndrome coronavirus 2, Antibodies, Neutralizing;  Antibodies, Viral;  BNT162 Vaccine;  COVID-19;  Enzyme-Linked Immunosorbent Assay;  Humans;  SARS-CoV-2;  Spike Glycoprotein, Coronavirus
TODO - Background: SARS-CoV-2 Spike protein Receptor Binding Domain neutralizing antibodies (NAbs-RBD) inhibit the viral binding to angiotensin-converting enzyme 2 (ACE2) receptors. We compared an ELISA and a fluorescence immunochromatography (FIC) method in NAbs-RBD detection after COVID-19 immunization. Method: Serum samples from healthcare workers (HCWs) vaccinated with BNT162b2 were collected one and four months after the second dose. NAbs-RBD (%) detection was performed using ELISA cPass™ (FDA approved) and FIC n-AbCOVID-19® assays. Results: Samples from 200 HCWs [median age (IQR): 45(35−53)] were tested with both assays. There was a good qualitative agreement between the two methods [AUC: 0.92(95%C.I.: 0.89–0.94, P-value:0.007)]. NAbs-RBD (%), one and four months after immunization, were significantly lower with FIC compared to ELISA for all age groups (P-value<0.0001). The quantitative comparison between FIC and ELISA detected slight agreement one month after the second dose [(Lin's Concordance Correlation Coefficient (CCC): 0.21(95%CI: 0.15–0.27)] which improved four months after the second dose [CCC: 0.6(95%CI: 0.54–0.66)]. Conclusion: FIC had good qualitative agreement with ELISA in the detection of positive NAbs-RBD (%) and could be an alternative for rapid NAbs-RBD (%) testing. © 2023
ER -