Abstract:
:The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of Coronavirus Disease 2019 (COVID-19). While molecular-based testing is used to diagnose COVID-19, serologic testing of antibodies specific to SARS-CoV-2 is used to detect past infection. While most serologic assays are qualitative, a quantitative serologic assay was recently developed that measures antibodies against the S protein, the target of vaccines. Quantitative antibody determination may help determine antibody titer, facilitate longitudinal monitoring of the antibody response, including antibody response to vaccines. We evaluated the quantitative Roche Elecsys® Anti-SARS-CoV-2 S assay. Specimens from 167 PCR-positive patients and 103 control specimens were analyzed using the Elecsys® Anti-SARS-CoV-2 S assay on the cobas e411 (Roche Diagnostics). Analytical evaluation included assessing linearity, imprecision, and analytical sensitivity. Clinical evaluation included assessing clinical sensitivity, specificity, cross-reactivity, positive predictive value (PPV), negative predictive value (NPV), and serial sampling from the same patient. The Elecsys® Anti-SARS-CoV-2 S assay exhibited highest sensitivity of 84.0% 15-30 days post-PCR positivity, no cross-reactivity, specificity and PPV of 100%, and NPV between 98.3%-99.8% ≥14 days post-PCR positivity, depending on the seroprevalence estimate. Imprecision was <2% at 9.06 U/mL across 6 days, the negative QC was consistently negative (<0.40 U/mL), the manufacturer's claimed limit of quantitation of 0.40 U/mL was verified, and linearity across the analytical measuring range was observed, except at the low end (<20 U/mL). Lastly antibody response showed high inter-individual variation in level and time of peak antibody titre and trends over time.
journal_name
J Clin Microbioljournal_title
Journal of clinical microbiologyauthors
Higgins V,Fabros A,Kulasingam Vdoi
10.1128/JCM.03149-20subject
Has Abstractpub_date
2021-01-22 00:00:00eissn
0095-1137issn
1098-660Xpii
JCM.03149-20pub_type
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