Comparison of Two Automated Immunoassays for the Detection of SARS-CoV-2 Nucleocapsid Antibodies

Comparison of Two Automated Immunoassays for the Detection of SARS-CoV-2 Nucleocapsid Antibodies

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel member of the coronavirus family that caused the global coronavirus 2019 (COVID-19) pandemic. The prevalence remains largely unknown because of early testing supply shortages. Although it cannot currently be used to determine le...

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Published in:The journal of applied laboratory medicine Vol. 6; no. 2; pp. 429 - 440
Main Authors: Hubbard, Jacqueline A, Geno, K Aaron, Khan, Jenna, Szczepiorkowski, Zbigniew M, de Gijsel, David, Ovalle, Anais A, AlSalman, Ahmad S, Gallagher, Torrey L, Johnston, Abigail A, Tibbetts, Amanda R, Vital, Sarah E, Cervinski, Mark A, Nerenz, Robert D
Format: Journal Article
Language:English
Published: England Oxford University Press 01-03-2021
Subjects:
Antibodies, Viral - blood
Antibodies, Viral - immunology
Antibodies, Viral - isolation & purification
COVID-19 - blood
COVID-19 - diagnosis
COVID-19 - immunology
COVID-19 - virology
COVID-19 Serological Testing - instrumentation
Humans
Nucleocapsid - immunology
Reagent Kits, Diagnostic
SARS-CoV-2 - immunology
SARS-CoV-2 - isolation & purification
Sensitivity and Specificity
Seroconversion
COVID-19
convalescent
IgG
coronavirus
SARS-CoV-2
antibody
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Summary:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel member of the coronavirus family that caused the global coronavirus 2019 (COVID-19) pandemic. The prevalence remains largely unknown because of early testing supply shortages. Although it cannot currently be used to determine level of immunity, antibody testing can contribute to epidemiological studies, identify convalescent plasma donors, or satisfy curiosity about previous exposure to the virus. 407 samples collected from hospitalized inpatients with and without a confirmed SARS-CoV-2 infection, 170 remnant clinical specimens collected and frozen prior to the COVID-19 outbreak, and paired serum and plasma samples from 23 convalescent plasma donors were used to determine performance characteristics of the Abbott SARS-CoV-2 IgG and Roche Elecsys Anti-SARS-CoV-2 assays. The sensitivity, specificity, imprecision, interferences, and sample stability were determined. These assays were then used to characterize the antibody response in serial samples from 20 SARS-CoV-2 positive inpatients. Both assays exhibited 100% specificity (95% CI; 99.05-100.00), giving no positive results in 170 specimens collected before July 2019 and 215 specimens from patients without a confirmed SARS-CoV-2 infection. Differences between platforms were most notable in SARS-CoV-2 positive samples. Roche offered higher sensitivity in convalescent plasma donors at 95.7% (95% CI; 78.1-99.9) versus 91.3% (95% CI; 72.0-98.9) but Abbott detected antibodies in 2 immunocompromised patients whereas Roche did not. The Roche and Abbott platforms also exhibited different trends in antibody signal for a subset of patients. Both the Abbott and Roche platforms offer excellent specificity but different trends in antibody signal may reflect qualitative differences in the types of antibodies recognized by the 2 assays. Negative serologic results do not exclude previous SARS-CoV-2 infection.
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ISSN:2576-9456
2475-7241
DOI:10.1093/jalm/jfaa175