Analytical assessment of Beckman Coulter Access anti-SARS-CoV-2 IgG immunoassay
Maurizio Ruscio,Elisa D’Agnolo,Anna Belgrano,Mario Plebani,Giuseppe Lippi +4 more
- Vol. 6, pp 3-3
Reads0
Chats0
TLDR
The results of this analytical evaluation of Beckman Coulter Access anti-SARS-CoV-2 IgG suggests that this fully-automated chemiluminescent immunoassay represents a valuable resource for large and accurate seroprevalence surveys.Abstract:
Background: The approach to diagnosing, treating and monitoring severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection relies strongly on laboratory resources, with serological testing representing the mainstay for studying the onset, nature and persistence of humoral immune response. This study was aimed at evaluating the analytical performance of the novel Beckman Coulter anti-SARS-CoV-2 immunoglobulins G (IgG) chemiluminescent immunoassay. Methods: This analytical assessment encompassed the calculation of intra-assay, inter-assay and total imprecision, linearity, limit of blank (LOB), limit of detection (LOD), functional sensitivity, and comparison of anti-SARS-CoV-2 antibodies values obtained on paired serum samples using DiaSorin Liaison SARS-CoV-2 S1/S2 IgG and Roche Elecsys Anti-SARS-CoV-2 total antibodies. Diagnostic performance was also tested against results of molecular testing on nasopharyngeal swabs, collected over the previous 4 months. Results: Intra-assay, inter-assay and total imprecision of Beckman Coulter anti-SARS-CoV-2 IgG were between 4.3-4.8%, 2.3-3.9% and 4.9-6.2%, respectively. The linearity of the assay was excellent between 0.11-18.8 antibody titers. The LOB, LOD and functional sensitivity were 0.02, 0.02 and 0.05, respectively. The diagnostic accuracy (area under the curve;AUC) of Beckman Coulter anti-SARS-CoV-2 IgG compared to molecular testing was 0.87 (95% CI, 0.84-0.91;P<0.001) using manufacturer's cut-off, and increased to 0.90 (95% CI, 0.86-0.94;P<0.001) with antibody titers. The AUC was non-significantly different from that of Roche Elecsys Anti-SARS-CoV-2, but was always higher than that of DiaSorin Liaison SARS-CoV-2 S1/S2 IgG. The correlation of Beckman Coulter Access SARS-CoV-2 IgG was 0.80 (95% CI, 0.75-0.84;P<0.001) with Roche Elecsys Anti-SARS-CoV-2 and 0.72 (95% CI, 0.66-0.77;P<0.001) with DiaSorin Liaison SARS-CoV-2 S1/S2 IgG, respectively. Conclusions: The results of this analytical evaluation of Beckman Coulter Access anti-SARS-CoV-2 IgG suggests that this fully-automated chemiluminescent immunoassay represents a valuable resource for large and accurate seroprevalence surveys. © Journal of Laboratory and Precision Medicine. All rights reserved.read more
Citations
More filters
Journal ArticleDOI
Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme.
Alena Moerman,Kris Vernelen,Bernard China,Arnaud Capron,Dorien Van den Bossche,Joachim Mariën,Kevin K. Ariën,Jos Van Acker,Marie-Luce Delforge,Marijke Reynders,An Boel,Melissa Depypere,Natasja Van Gasse,Sara Vijgen,Jonathan Brauner,Barbara Dujardin,Elizaveta Padalko +16 more
TL;DR: In this article, the authors report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme.
Journal ArticleDOI
Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme
TL;DR: In this paper , the authors report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme.
References
More filters
Limit of blank, limit of detection and limit of quantitation.
David A Armbruster,Terry Pry +1 more
TL;DR: The Limit of Blank, Limit of Detection, and Limit of Quantitation are terms used to describe the smallest concentration of a measurand that can be reliably measured by an analytical procedure.
Journal ArticleDOI
Humoral Immune Response to SARS-CoV-2 in Iceland.
Daniel F. Gudbjartsson,Gudmundur L. Norddahl,Páll Melsted,Kristbjorg Gunnarsdottir,Hilma Holm,Elias Eythorsson,Asgeir O. Arnthorsson,Dadi Helgason,Kristbjorg Bjarnadottir,Ragnar Freyr Ingvarsson,Brynja Thorsteinsdottir,Steinunn Kristjánsdóttir,Kolbrun Birgisdottir,Anna M. Kristinsdottir,Martin I. Sigurdsson,Gudny A. Arnadottir,Erna V. Ivarsdottir,Margret B. Andresdottir,Frosti Jonsson,Arna B Agustsdottir,Jonas Berglund,Berglind Eiriksdottir,Run Fridriksdottir,Elisabet E Gardarsdottir,Magnus Gottfredsson,Olafia S Gretarsdottir,Steinunn Gudmundsdottir,Kjartan R Gudmundsson,Thora R Gunnarsdottir,Arnaldur Gylfason,Agnar Helgason,Brynjar O. Jensson,Aslaug Jonasdottir,Hakon Jonsson,Thordur Kristjansson,Karl G. Kristinsson,Droplaug N Magnusdottir,Olafur T. Magnusson,Lovisa Bjork Olafsdottir,Solvi Rognvaldsson,Louise le Roux,Gudrun Sigmundsdottir,Asgeir Sigurdsson,Gardar Sveinbjornsson,Kristin E Sveinsdottir,Maney Sveinsdottir,Emil A Thorarensen,Bjarni Thorbjornsson,Marianna Thordardottir,Jona Saemundsdottir,S Hjortur Kristjansson,Kamilla S Josefsdottir,Gisli Masson,Gudmundur Georgsson,Mar Kristjansson,Alma D. Möller,Runolfur Palsson,Thorolfur Gudnason,Unnur Thorsteinsdottir,Ingileif Jonsdottir,Patrick Sulem,Kari Stefansson +61 more
TL;DR: The authors' results indicate that antiviral antibodies against SARS-CoV-2 did not decline within 4 months after diagnosis, and antiviral antibody titers assayed by two pan-Ig assays remained on a plateau for the remainder of the study.
Journal ArticleDOI
A systematic review of antibody mediated immunity to coronaviruses: kinetics, correlates of protection, and association with severity.
Angkana T. Huang,Bernardo García-Carreras,Matthew D. Hitchings,Bingyi Yang,Leah C. Katzelnick,Susan M Rattigan,Brooke A. Borgert,Carlos A. Moreno,Benjamin D. Solomon,Luke Trimmer-Smith,Veronique Etienne,Isabel Rodriguez-Barraquer,Justin Lessler,Henrik Salje,Henrik Salje,Henrik Salje,Donald S. Burke,Amy Wesolowski,Derek A. T. Cummings +18 more
TL;DR: While further studies of SARS-CoV-2 are necessary to determine immune responses, evidence from other coronaviruses can provide clues and guide future research.
Journal ArticleDOI
Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis.
Mayara Lisboa Bastos,Mayara Lisboa Bastos,Gamuchirai Tavaziva,S.K. Abidi,Jonathon R. Campbell,Jonathon R. Campbell,Louis-Patrick Haraoui,James C. Johnston,Zhiyi Lan,Stephanie Law,Emily MacLean,Anete Trajman,Anete Trajman,Dick Menzies,Dick Menzies,Andrea Benedetti,Andrea Benedetti,Faiz Ahmad Khan,Faiz Ahmad Khan +18 more
TL;DR: Higher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed, as available evidence does not support the continued use of existing point-of-care serological Tests for coronavirus disease-2019.
Journal ArticleDOI
Persistence and decay of human antibody responses to the receptor binding domain of SARS-CoV-2 spike protein in COVID-19 patients.
Anita S. Iyer,Forrest K. Jones,Ariana Nodoushani,Meagan Kelly,Margaret Becker,Damien Slater,Rachel Mills,Erica Teng,Mohammad Kamruzzaman,Wilfredo F. Garcia-Beltran,Michael G Astudillo,Diane Yang,Tyler E. Miller,Elizabeth Oliver,Stephanie Fischinger,Caroline Atyeo,A. John Iafrate,Stephen B. Calderwood,Stephen A. Lauer,Jingyou Yu,Zhenfeng Li,Jared Feldman,Blake M. Hauser,Timothy M. Caradonna,John A. Branda,Sarah E Turbett,Regina C. LaRocque,Guillaume Mellon,Dan H. Barouch,Dan H. Barouch,Aaron G. Schmidt,Aaron G. Schmidt,Andrew S. Azman,Galit Alter,Edward T. Ryan,Jason B. Harris,Richelle C. Charles +36 more
TL;DR: RBD-targeted antibodies are excellent markers of previous and recent infection, that differential isotype measurements can help distinguish between recent and older infections, and that IgG responses persist over the first few months after infection and are highly correlated with neutralizing antibodies.