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Cross-Institutional Evaluation of the Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay.
Wiencek, Joesph R; Bachmann, Lorin M; Dinwiddie, Kelly; Miller, Greg W; Bazydlo, Lindsay A L.
  • Wiencek JR; Department of Pathology, University of Virginia (UVA) School of Medicine, Charlottesville, Virginia.
  • Bachmann LM; Department of Pathology, Virginia Commonwealth University, Richmond, Virginia.
  • Dinwiddie K; Medical Laboratories, University of Virginia Health System, Charlottesville, Virginia.
  • Miller GW; Department of Pathology, Virginia Commonwealth University, Richmond, Virginia.
  • Bazydlo LAL; Department of Pathology, University of Virginia (UVA) School of Medicine, Charlottesville, Virginia.
Lab Med ; 52(5): e137-e146, 2021 Sep 01.
Article in English | MEDLINE | ID: covidwho-2135433
Semantic information from SemMedBD (by NLM)
1. Immunoenzyme Procedure USES SARS-CoV-2 IgG
Subject
Immunoenzyme Procedure
Predicate
USES
Object
SARS-CoV-2 IgG
2. Assay USES Antibodies
Subject
Assay
Predicate
USES
Object
Antibodies
3. Academic Medical Centers LOCATION_OF Assay
Subject
Academic Medical Centers
Predicate
LOCATION_OF
Object
Assay
4. Immunoenzyme Procedure USES SARS-CoV-2 IgG
Subject
Immunoenzyme Procedure
Predicate
USES
Object
SARS-CoV-2 IgG
5. Assay USES Antibodies
Subject
Assay
Predicate
USES
Object
Antibodies
6. Academic Medical Centers LOCATION_OF Assay
Subject
Academic Medical Centers
Predicate
LOCATION_OF
Object
Assay
ABSTRACT

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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Immunoassay / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Country/Region as subject: North America Language: English Journal: Lab Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Immunoassay / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Country/Region as subject: North America Language: English Journal: Lab Med Year: 2021 Document Type: Article