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Lab Med ; 52(5): e137-e146, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-33929022

RESUMO

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.


Assuntos
Anticorpos Antivirais/sangue , Teste Sorológico para COVID-19/normas , COVID-19/diagnóstico , Imunoensaio/normas , Imunoglobulina G/sangue , SARS-CoV-2/imunologia , Centros Médicos Acadêmicos , COVID-19/sangue , COVID-19/imunologia , COVID-19/virologia , Humanos , Variações Dependentes do Observador , Reprodutibilidade dos Testes , SARS-CoV-2/patogenicidade , Sensibilidade e Especificidade , Virginia
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