Journal of Clinical MicrobiologyArticleMarch 2021
Quantitative Measurement of Anti-SARS-CoV-2 Antibodies: Analytical and Clinical Evaluation
Volume fifty nine, Number 4
19 March 2021
- ABSTRACT
- REFERENCES
The excessive acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19). Molecular-based totally checking out is used to diagnose COVID-19, and serologic trying out of antibodies particular to SARS-CoV-2 is used to stumble on past infection. While maximum serologic assays are qualitative, a quantitative serologic assay became recently evolved that measures antibodies in opposition to the S protein, the goal of vaccines. Quantitative antibody dedication can also assist decide antibody titer and facilitate longitudinal tracking of the antibody response, which includes antibody response to vaccines. We evaluated the quantitative Roche Elecsys anti-SARS-CoV-2 S assay. Specimens from 167 PCR-nice sufferers and 103 manipulate specimens have been analyzed using the Elecsys anti-SARS-CoV-2 S assay on the cobas e411 (Roche Diagnostics). Analytical assessment covered assessing linearity, imprecision, and analytical sensitivity. Clinical assessment included assessing scientific sensitivity, specificity, cross-reactivity, effective predictive cost (PPV), poor predictive price (NPV), and serial sampling from the same patient. The Elecsys anti-SARS-CoV-2 S assay exhibited its maximum sensitivity (84.0%) at 15 to 30 days submit-PCR positivity and exhibited no move-reactivity, a specificity and PPV of a hundred%, and an NPV among ninety eight.three% and 99.eight% at ≥14 days publish-PCR positivity, depending on the seroprevalence estimate. Imprecision was <2% at nine.06 U/ml across 6 days, the negative pleasant manage (QC) turned into constantly poor (<0.forty U/ml), the producer’s claimed limit of quantitation of 0.forty U/ml became validated, and linearity throughout the analytical measuring range turned into determined, except on the low cease (<20 U/ml). Lastly, antibody response confirmed excessive interindividual variant in level and time of top antibody titer and traits over the years.REFERENCES
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Journal of Clinical Microbiology
Volume fifty nine • Number four • 19 March 2021
Editor: Michael J. Loeffelholz, CepheidHistory
Returned for change: four January 2021
Published online: 19 March 2021CopyrightPermissions
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Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
Division of Clinical Biochemistry, Laboratory Medicine Program, University Health Network, Toronto, Ontario, Canada
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
Division of Clinical Biochemistry, Laboratory Medicine Program, University Health Network, Toronto, Ontario, CanadaEditorMetrics & CitationsMetricsCitations
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Journal of Clinical MicrobiologyArticleMay 2008
RNase-Resistant Virus-Like Particles Containing Long Chimeric RNA Sequences Produced by way of Two-Plasmid Coexpression System
Volume forty six, Number 5
May 2008
- ABSTRACT
- REFERENCES
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