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Evaluation of a Novel Multiplex Platform for Simultaneous Detection of IgG Antibodies Against the 4 Main SARS-CoV-2 Antigens.
Nandakumar, Vijayalakshmi; Profaizer, Tracie; Lozier, Bucky K; Elgort, Marc G; Rychert, Jenna; Slev, Patricia R; Delgado, Julio C.
  • Nandakumar V; ARUP Institute for Clinical and Experimental Pathology®, Salt Lake City, UT, USA.
  • Profaizer T; Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA.
  • Lozier BK; ARUP Institute for Clinical and Experimental Pathology®, Salt Lake City, UT, USA.
  • Elgort MG; ARUP Institute for Clinical and Experimental Pathology®, Salt Lake City, UT, USA.
  • Rychert J; ARUP Institute for Clinical and Experimental Pathology®, Salt Lake City, UT, USA.
  • Slev PR; Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA.
  • Delgado JC; ARUP Institute for Clinical and Experimental Pathology®, Salt Lake City, UT, USA.
J Appl Lab Med ; 7(3): 698-710, 2022 05 04.
Article in English | MEDLINE | ID: covidwho-1831206
ABSTRACT

BACKGROUND:

Numerous serology assays are available for detection of SARS-CoV-2 antibodies but are limited in that only 1 or 2 target antigen(s) can be tested at a time. Here, we describe a novel multiplex assay that simultaneously detects and quantifies IgG antibodies to SARS-CoV-2 antigens, spike (S), nucleocapsid (N), receptor-binding domain (RBD), and N-terminal domain (NTD) in a single well.

METHODS:

Sensitivity was determined using samples (n = 124) from confirmed SARS-CoV-2 RT-PCR positive individuals. Prepandemic (n = 100) and non-COVID respiratory infection positive samples (n = 100) were used to evaluate specificity. Samples were analyzed using COVID-19 IgG multiplex serology assay from Meso Scale Discovery (MSD) and using commercial platforms from Abbott, EUROIMMUN, and Siemens.

RESULTS:

At >14 days post-PCR, MSD assay displayed >98.0% sensitivity [S 100% (95% CI 98.0%-100.0%); N 98.0% (95% CI 97.2%-98.9%); RBD 94.1% (95% CI 92.6%-95.6%); NTD 98.0% (95% CI, 97.2%-98.9%)] and 99% specificity (95% CI 99.3%-99.7%) for antibodies to all 4 antigens. Parallel assessment of antibodies to more than 1 antigen improved the sensitivity to 100% (95% CI 98.0%-100.0%) while maintaining 98% (95% CI 97.6%-98.4%) specificity regardless of the combinations used. When AU/mL concentrations of IgG antibodies from the MSD assay were compared against the corresponding IgG signals acquired from the single target commercial assays, the following correlations were observed Abbott (vs MSD N, R2 = 0.73), Siemens (vs MSD RBD, R2 = 0.92), and EUROIMMUN (vs MSD S, R2 = 0.82).

CONCLUSION:

MSD assay offers an accurate and a comprehensive assessment of SARS-CoV-2 antibodies with higher sensitivity and equivalent specificity compared to the commercial IgG serology assays.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies Limits: Humans Language: English Journal: J Appl Lab Med Year: 2022 Document Type: Article Affiliation country: Jalm

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies Limits: Humans Language: English Journal: J Appl Lab Med Year: 2022 Document Type: Article Affiliation country: Jalm