雅培 ARCHITECT SARS-CoV-2 IgG 免疫分析的跨机构评估。
Cross-Institutional Evaluation of the Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay.
机构信息
Department of Pathology, University of Virginia (UVA) School of Medicine, Charlottesville, Virginia.
Department of Pathology, Virginia Commonwealth University, Richmond, Virginia.
出版信息
Lab Med. 2021 Sep 1;52(5):e137-e146. doi: 10.1093/labmed/lmab011.
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.
目的
描述一种跨机构方法来验证雅培 ARCHITECT SARS-CoV-2 抗体检测，并记录血清学反应的动力学。
方法
我们在 2 个学术医疗中心的 5 台 Abbott ARCHITECT i2000 自动化分析仪上进行了雅培 ARCHITECT SARS-CoV-2 抗体检测的分析性能评估研究。
结果
在每个机构中，抗体检测的批内和批间变异系数（CV）均不超过 5.6%和 8.6%。锂肝素血浆、EDTA-血浆和血清标本类型的定量和定性结果一致。除了 1 个机构的 1 个标本外，所有 SARS-CoV-2 IgG 阳性和阴性标本的结果在各分析仪之间均一致。机构之间交换的标本的定性和定量结果一致。所有患者从发病第 10 天开始均检测到抗体，并在整个标本采集期间保持血清学阳性。
结论
该 Abbott ARCHITECT SARS-CoV-2 抗体检测在 2 个学术医疗中心临床实验室内部和实验室之间的分析性能特征可接受，可广泛用于临床实验室。
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