Cross-Institutional Evaluation of the Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay

被引：2

作者：

Wiencek, Joesph R. ^{[1
]}

Bachmann, Lorin M. ^{[2
]}

Dinwiddie, Kelly ^{[3
]}

Miller, Greg W. ^{[2
]}

Bazydlo, Lindsay A. L. ^{[1
]}

机构：

[1] Univ Virginia UVA, Dept Pathol, Sch Med, Charlottesville, VA 22904 USA

[2] Virginia Commonwealth Univ, Dept Pathol, Richmond, VA USA

[3] Univ Virginia Hlth Syst, Med Labs, Charlottesville, VA USA

来源：

LABORATORY MEDICINE | 2021年 / 52卷 / 05期

关键词：

antibody; COVID-19; EUA; immunoassay; SARS-CoV-2; serology;

D O I：

10.1093/labmed/lmab011

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

Objective: To describe a cross-institutional approach to verify the Abbott ARCHITECT SARS-CoV-2 antibody assay and to document the kinetics of the serological response. Methods: We conducted analytical performance evaluation studies using the Abbott ARCHITECT SARS-CoV-2 antibody assay on 5 Abbott ARCHITECT i2000 automated analyzers at 2 academic medical centers. Results: Within-run and between-run coefficients of variance (CVs) for the antibody assay did not exceed 5.6% and 8.6%, respectively, for each institution. Quantitative and qualitative results agreed for lithium heparin plasma, EDTA-plasma and serum specimen types. Results for all SARS-CoV-2 IgG-positive and -negative specimens were concordant among analyzers except for 1 specimen at 1 institution. Qualitative and quantitative agreement was observed for specimens exchanged between institutions. All patients had detectable antibodies by day 10 from symptom onset and maintained seropositivity throughout specimen procurement. Conclusions: The analytical performance characteristics of the Abbott ARCHITECT SARS-CoV-2 antibody assay within and between 2 academic medical center clinical laboratories were acceptable for widespread clinical-laboratory use.

引用

页码：E137 / E146

页数：10

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