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Evaluation of a Surrogate Enzyme-Linked Immunosorbent Assay-Based Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) cPass Neutralization Antibody Detection Assay and Correlation With Immunoglobulin G Commercial Serology Assays.
Nandakumar, Vijayalakshmi; Profaizer, Tracie; Lozier, Bucky K; Elgort, Marc G; Larragoite, Erin T; Williams, Elizabeth S C P; Solis-Leal, Antonio; Lopez, J Brandon; Berges, Bradford K; Planelles, Vicente; Rychert, Jenna; Slev, Patricia R; Delgado, Julio C.
  • Nandakumar V; From the ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, Utah (Nandakumar, Profaizer, Lozier, Elgort, Rychert, Slev, Delgado).
  • Profaizer T; the Department of Pathology, University of Utah School of Medicine, Salt Lake City (Nandakumar, Larragoite, Williams, Planelles, Rychert, Slev, Delgado).
  • Lozier BK; From the ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, Utah (Nandakumar, Profaizer, Lozier, Elgort, Rychert, Slev, Delgado).
  • Elgort MG; From the ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, Utah (Nandakumar, Profaizer, Lozier, Elgort, Rychert, Slev, Delgado).
  • Larragoite ET; From the ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, Utah (Nandakumar, Profaizer, Lozier, Elgort, Rychert, Slev, Delgado).
  • Williams ESCP; the Department of Pathology, University of Utah School of Medicine, Salt Lake City (Nandakumar, Larragoite, Williams, Planelles, Rychert, Slev, Delgado).
  • Solis-Leal A; the Department of Pathology, University of Utah School of Medicine, Salt Lake City (Nandakumar, Larragoite, Williams, Planelles, Rychert, Slev, Delgado).
  • Lopez JB; the Department of Microbiology & Molecular Biology, Brigham Young University, Provo, Utah (Solis-Leal, Lopez, Berges).
  • Berges BK; the Department of Microbiology & Molecular Biology, Brigham Young University, Provo, Utah (Solis-Leal, Lopez, Berges).
  • Planelles V; the Department of Microbiology & Molecular Biology, Brigham Young University, Provo, Utah (Solis-Leal, Lopez, Berges).
  • Rychert J; the Department of Pathology, University of Utah School of Medicine, Salt Lake City (Nandakumar, Larragoite, Williams, Planelles, Rychert, Slev, Delgado).
  • Slev PR; From the ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, Utah (Nandakumar, Profaizer, Lozier, Elgort, Rychert, Slev, Delgado).
  • Delgado JC; the Department of Pathology, University of Utah School of Medicine, Salt Lake City (Nandakumar, Larragoite, Williams, Planelles, Rychert, Slev, Delgado).
Arch Pathol Lab Med ; 145(10): 1212-1220, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1444461
ABSTRACT
CONTEXT.­ Emerging evidence shows correlation between the presence of neutralization antibodies (nAbs) and protective immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently available commercial serology assays lack the ability to specifically identify nAbs. An enzyme-linked immunosorbent assay-based nAb assay (GenScript cPass neutralization antibody assay) has recently received emergency use authorization from the Food and Drug Administration. OBJECTIVE.­ To evaluate the performance characteristics of this assay and compare and correlate it with the commercial assays that detect SARS-CoV-2-specific immunoglobulin G (IgG). DESIGN.­ Specimens from SARS-COV-2 infected patients (n = 124), healthy donors obtained prepandemic (n = 100), and patients with non-coronavirus disease 2019 (COVID-19) respiratory infections (n = 92) were analyzed using this assay. Samples with residual volume were also tested on 3 commercial serology platforms (Abbott, Euroimmun, Siemens). Twenty-eight randomly selected specimens from patients with COVID-19 and 10 healthy controls were subjected to a plaque reduction neutralization test. RESULTS.­ The cPass assay exhibited 96.1% (95% CI, 94.9%-97.3%) sensitivity (at >14 days post-positive PCR), 100% (95% CI, 98.0%-100.0%) specificity, and zero cross-reactivity for the presence of non-COVID-19 respiratory infections. When compared with the plaque reduction assay, 97.4% (95% CI, 96.2%-98.5%) qualitative agreement and a positive correlation (R2 = 0.76) was observed. Comparison of IgG signals from each of the commercial assays with the nAb results from plaque reduction neutralization test/cPass assays displayed greater than 94.7% qualitative agreement and correlations with R2 = 0.43/0.68 (Abbott), R2 = 0.57/0.85 (Euroimmun), and R2 = 0.39/0.63 (Siemens), respectively. CONCLUSIONS.­ The combined data support the use of cPass assay for accurate detection of the nAb response. Positive IgG results from commercial assays associated reasonably with nAbs presence and can serve as a substitute.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Enzyme-Linked Immunosorbent Assay / Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Adolescent / Adult / Aged / Child / Child, preschool / Humans / Middle aged / Young adult Language: English Journal: Arch Pathol Lab Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Enzyme-Linked Immunosorbent Assay / Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Adolescent / Adult / Aged / Child / Child, preschool / Humans / Middle aged / Young adult Language: English Journal: Arch Pathol Lab Med Year: 2021 Document Type: Article