Examination of SARS-CoV-2 serological test results from multiple commercial and laboratory platforms with an in-house serum panel.

Autor:	Lester SN; Respiratory Viruses Immunology Team, CDC, Atlanta, Georgia, USA., Stumpf M; Eagle Global Scientific, LLC, Atlanta, Georgia, USA., Freeman BD; Respiratory Viruses Immunology Team, CDC, Atlanta, Georgia, USA., Mills L; Eagle Global Scientific, LLC, Atlanta, Georgia, USA., Schiffer J; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Semenova V; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Jia T; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Desai R; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Browning P; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Alston B; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Ategbole M; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Bolcen S; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Chen A; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., David E; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Manitis P; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Tatum H; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Qin Y; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Zellner B; Microbial Pathogenesis & Immune Response Team, CDC, Atlanta, Georgia, USA., Drobeniuc J; Division of Viral Hepatitis, National Center for HIV Viral Hepatitis STD and TB Prevention, Atlanta, Georgia, USA., Tejada-Strop A; Division of Viral Hepatitis, National Center for HIV Viral Hepatitis STD and TB Prevention, Atlanta, Georgia, USA., Chatterjee P; Viral Special Pathogens Branch, CDC, Atlanta, Georgia, USA., Shrivastava-Ranjan P; Viral Special Pathogens Branch, CDC, Atlanta, Georgia, USA., Jenks MH; Viral Special Pathogens Branch, CDC, Atlanta, Georgia, USA., McMullan LK; Viral Special Pathogens Branch, CDC, Atlanta, Georgia, USA., Flint M; Viral Special Pathogens Branch, CDC, Atlanta, Georgia, USA., Spiropoulou CF; Viral Special Pathogens Branch, CDC, Atlanta, Georgia, USA., Niemeyer GP; Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, CDC, Atlanta, Georgia, USA., Werner BJ; Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, CDC, Atlanta, Georgia, USA., Bean CJ; Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, CDC, Atlanta, Georgia, USA., Johnson JA; National Center for HIV Viral Hepatitis STD and TB Prevention, Atlanta, Georgia, USA., Hoffmaster AR; Bacterial Special Pathogens Branch, DHCPP, CDC, Atlanta, Georgia, USA., Satheshkumar PS; Poxvirus and Rabies Branch, CDC, Atlanta, Georgia, USA., Schuh AJ; Viral Special Pathogens Branch, CDC, Atlanta, Georgia, USA., Owen SM; National Center for HIV Viral Hepatitis STD and TB Prevention, Atlanta, Georgia, USA., Thornburg NJ; Respiratory Viruses Immunology Team, CDC, Atlanta, Georgia, USA.
Jazyk:	angličtina
Zdroj:	Access microbiology [Access Microbiol] 2024 Feb 29; Vol. 6 (2). Date of Electronic Publication: 2024 Feb 29 (Print Publication: 2024).
DOI:	10.1099/acmi.0.000463.v4
Abstrakt:	Severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) is a novel human coronavirus that was identified in 2019. SARS-CoV-2 infection results in an acute, severe respiratory disease called coronavirus disease 2019 (COVID-19). The emergence and rapid spread of SARS-CoV-2 has led to a global public health crisis, which continues to affect populations across the globe. Real time reverse transcription polymerase chain reaction (rRT-PCR) is the reference standard test for COVID-19 diagnosis. Serological tests are valuable tools for serosurveillance programs and establishing correlates of protection from disease. This study evaluated the performance of one in-house enzyme linked immunosorbent assay (ELISA) utilizing the pre-fusion stabilized ectodomain of SARS-CoV-2 spike (S), two commercially available chemiluminescence assays Ortho VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Abbott SARS-CoV-2 IgG assay and one commercially available Surrogate Virus Neutralization Test (sVNT), GenScript USA Inc., cPass SARS-CoV-2 Neutralization Antibody Detection Kit for the detection of SARS-CoV-2 specific antibodies. Using a panel of rRT-PCR confirmed COVID-19 patients' sera and a negative control group as a reference standard, all three immunoassays demonstrated high comparable positivity rates and low discordant rates. All three immunoassays were highly sensitive with estimated sensitivities ranging from 95.4-96.6 %. ROC curve analysis indicated that all three immunoassays had high diagnostic accuracies with area under the curve (AUC) values ranging from 0.9698 to 0.9807. High positive correlation was demonstrated among the conventional microneutralization test (MNT) titers and the sVNT inhibition percent values. Our study indicates that independent evaluations are necessary to optimize the overall utility and the interpretation of the results of serological tests. Overall, we demonstrate that all serological tests evaluated in this study are suitable for the detection of SARS-CoV-2 antibodies. Competing Interests: ‘The author(s) declare that there are no conflicts of interest’. The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Names of specific vendors, manufacturers, or products are included for public health and informational purposes; inclusion does not imply endorsement of the vendors, manufacturers, or products by the Centers for Disease Control and Prevention or the US Department of Health and Human Services.
Databáze:	MEDLINE
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