Cross-Institutional Evaluation of the Abbott ARCHITECT SARS-CoV-2 IgG Immunoassay.
Lab Med
; 52(5): e137-e146, 2021 Sep 01.
Article
in English
| MEDLINE | ID: covidwho-2135433
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.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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