OBJECTIVES: A few CLIA automated immunoassays for the recognition of anti S1-RBD SARS-CoV-2 antibodies have recently been placed on the market. Preliminary data demonstrate a high correlation between methods but wide differences in absolute concentrations. A new WHO international standard for anti-SARS-CoV-2 immunoglobulin, NIBSC code 20/136, has been recently introduced to reduce the differences. The aim of this study is thus to verify the harmonization made by NIBSC 20/136 on Ab anti S1-RBD measurement on real samples. METHODS: The following assays were studied: LIAISON® SARS-CoV-2 TrimericS IgG (DiaSorin); Elecsys® anti-SARS-CoV-2 S (ROCHE); Atellica IM SARS-CoV-2 IgG (sCOVG) (Siemens); MAGLUMI® SARS-CoV-2 S-RBD IgG (Snibe), measuring 210 samples from 70 health workers with no previous SARS-CoV2 infection, during their Pfizer-BioNTech's BNT162b2 vaccination period. RESULTS: The recalculation of concentrations based on the NIBSC 20/136 standardization improve the analytical and diagnostic comparability but do not cancel this variability between methods: recalibrated results remain different across methods, both in terms of tendency and single data. CONCLUSIONS: The recalculation of concentrations based on the NIBSC 20/136 standardization improves the analytical and diagnostic comparability but does not cancel the differences between methods: recalibrated results remain different across methods, both in terms of tendency and single data.
OBJECTIVES: A few CLIA automated immunoassays for the recognition of anti S1-RBD SARS-CoV-2 antibodies have recently been placed on the market. Preliminary data demonstrate a high correlation between methods but wide differences in absolute concentrations. A new WHO international standard for anti-SARS-CoV-2 immunoglobulin, NIBSC code 20/136, has been recently introduced to reduce the differences. The aim of this study is thus to verify the harmonization made by NIBSC 20/136 on Ab anti S1-RBD measurement on real samples. METHODS: The following assays were studied: LIAISON® SARS-CoV-2 TrimericS IgG (DiaSorin); Elecsys® anti-SARS-CoV-2 S (ROCHE); Atellica IM SARS-CoV-2 IgG (sCOVG) (Siemens); MAGLUMI® SARS-CoV-2 S-RBD IgG (Snibe), measuring 210 samples from 70 health workers with no previous SARS-CoV2 infection, during their Pfizer-BioNTech's BNT162b2 vaccination period. RESULTS: The recalculation of concentrations based on the NIBSC 20/136 standardization improve the analytical and diagnostic comparability but do not cancel this variability between methods: recalibrated results remain different across methods, both in terms of tendency and single data. CONCLUSIONS: The recalculation of concentrations based on the NIBSC 20/136 standardization improves the analytical and diagnostic comparability but does not cancel the differences between methods: recalibrated results remain different across methods, both in terms of tendency and single data.
Authors: Jakub Swadźba; Tomasz Anyszek; Andrzej Panek; Agnieszka Chojęta; Kinga Wyrzykowska; Emilia Martin Journal: Diagnostics (Basel) Date: 2022-06-09
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Authors: Michael Kolland; Regina Riedl; Bernhard Bachler; Werner Ribitsch; Tobias Niedrist; Anna-Maria Meissl; Alexander R Rosenkranz; Alexander H Kirsch Journal: Nephrol Dial Transplant Date: 2022-05-25 Impact factor: 7.186
Authors: Niko Kohmer; Holger F Rabenau; Sandra Ciesek; Bernhard K Krämer; Uwe Göttmann; Christine Keller; Daniela Rose; Carsten Blume; Michael Thomas; Alexander Lammert; Anne Lammert Journal: Nephrol Dial Transplant Date: 2022-05-25 Impact factor: 7.186