Correlation between In Vitro Neutralization Assay and Serological Tests for Protective Antibodies Detection. 2022

Maria Addolorata Bonifacio, and Riccardo Laterza, and Angela Vinella, and Annalisa Schirinzi, and Mariangela Defilippis, and Francesca Di Serio, and Angelo Ostuni, and Antonio Fasanella, and Maria Addolorata Mariggiò
Department of Biomedical Sciences and Human Oncology, University of Bari Aldo Moro Medical School, 70124 Bari, Italy.

Serological assays are useful in investigating the development of humoral immunity against SARS-CoV-2 in the context of epidemiological studies focusing on the spread of protective immunity. The plaque reduction neutralization test (PRNT) is the gold standard method to assess the titer of protective antibodies in serum samples. However, to provide a result, the PRNT requires several days, skilled operators, and biosafety level 3 laboratories. Therefore, alternative methods are being assessed to establish a relationship between their outcomes and PRNT results. In this work, four different immunoassays (Roche Elecsys® Anti SARS-CoV-2 S, Snibe MAGLUMI® SARS-CoV-2 S-RBD IgG, Snibe MAGLUMI® 2019-nCoV IgG, and EUROIMMUN® SARS-CoV-2 NeutraLISA assays, respectively) have been performed on individuals healed after SARS-CoV-2 infection. The correlation between each assay and the reference method has been explored through linear regression modeling, as well as through the calculation of Pearson’s and Spearman’s coefficients. Furthermore, the ability of serological tests to discriminate samples with high titers of neutralizing antibodies (>160) has been assessed by ROC curve analyses, Cohen’s Kappa coefficient, and positive predictive agreement. The EUROIMMUN® NeutraLISA assay displayed the best correlation with PRNT results (Pearson and Spearman coefficients equal to 0.660 and 0.784, respectively), as well as the ROC curve with the highest accuracy, sensitivity, and specificity (0.857, 0.889, and 0.829, respectively).

UI MeSH Term Description Entries
D007074 Immunoglobulin G The major immunoglobulin isotype class in normal human serum. There are several isotype subclasses of IgG, for example, IgG1, IgG2A, and IgG2B. Gamma Globulin, 7S,IgG,IgG Antibody,Allerglobuline,IgG(T),IgG1,IgG2,IgG2A,IgG2B,IgG3,IgG4,Immunoglobulin GT,Polyglobin,7S Gamma Globulin,Antibody, IgG,GT, Immunoglobulin
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000086382 COVID-19 A viral disorder generally characterized by high FEVER; COUGH; DYSPNEA; CHILLS; PERSISTENT TREMOR; MUSCLE PAIN; HEADACHE; SORE THROAT; a new loss of taste and/or smell (see AGEUSIA and ANOSMIA) and other symptoms of a VIRAL PNEUMONIA. In severe cases, a myriad of coagulopathy associated symptoms often correlating with COVID-19 severity is seen (e.g., BLOOD COAGULATION; THROMBOSIS; ACUTE RESPIRATORY DISTRESS SYNDROME; SEIZURES; HEART ATTACK; STROKE; multiple CEREBRAL INFARCTIONS; KIDNEY FAILURE; catastrophic ANTIPHOSPHOLIPID ANTIBODY SYNDROME and/or DISSEMINATED INTRAVASCULAR COAGULATION). In younger patients, rare inflammatory syndromes are sometimes associated with COVID-19 (e.g., atypical KAWASAKI SYNDROME; TOXIC SHOCK SYNDROME; pediatric multisystem inflammatory disease; and CYTOKINE STORM SYNDROME). A coronavirus, SARS-CoV-2, in the genus BETACORONAVIRUS is the causative agent. 2019 Novel Coronavirus Disease,2019 Novel Coronavirus Infection,2019-nCoV Disease,2019-nCoV Infection,COVID-19 Pandemic,COVID-19 Pandemics,COVID-19 Virus Disease,COVID-19 Virus Infection,Coronavirus Disease 2019,Coronavirus Disease-19,SARS Coronavirus 2 Infection,SARS-CoV-2 Infection,Severe Acute Respiratory Syndrome Coronavirus 2 Infection,COVID19,2019 nCoV Disease,2019 nCoV Infection,2019-nCoV Diseases,2019-nCoV Infections,COVID 19,COVID 19 Pandemic,COVID 19 Virus Disease,COVID 19 Virus Infection,COVID-19 Virus Diseases,COVID-19 Virus Infections,Coronavirus Disease 19,Disease 2019, Coronavirus,Disease, 2019-nCoV,Disease, COVID-19 Virus,Infection, 2019-nCoV,Infection, COVID-19 Virus,Infection, SARS-CoV-2,Pandemic, COVID-19,SARS CoV 2 Infection,SARS-CoV-2 Infections,Virus Disease, COVID-19,Virus Infection, COVID-19
D000086402 SARS-CoV-2 A species of BETACORONAVIRUS causing atypical respiratory disease (COVID-19) in humans. The organism was first identified in 2019 in Wuhan, China. The natural host is the Chinese intermediate horseshoe bat, RHINOLOPHUS affinis. 2019 Novel Coronavirus,COVID-19 Virus,COVID19 Virus,Coronavirus Disease 2019 Virus,SARS Coronavirus 2,SARS-CoV-2 Virus,Severe Acute Respiratory Syndrome Coronavirus 2,Wuhan Coronavirus,Wuhan Seafood Market Pneumonia Virus,2019-nCoV,2019 Novel Coronaviruses,COVID 19 Virus,COVID-19 Viruses,COVID19 Viruses,Coronavirus 2, SARS,Coronavirus, 2019 Novel,Coronavirus, Wuhan,Novel Coronavirus, 2019,SARS CoV 2 Virus,SARS-CoV-2 Viruses,Virus, COVID-19,Virus, COVID19,Virus, SARS-CoV-2,Viruses, COVID19
D000086742 COVID-19 Testing Diagnosis of COVID-19 by assaying bodily fluids or tissues for the presence of COVID-19 antibodies, SARS-COV-2 antigens or the VIRAL RNA of SARS-COV-2. 2019 Novel Coronavirus Disease Testing,2019 Novel Coronavirus Testing,2019-nCoV Disease Testing,2019-nCoV Infection Testing,2019-nCoV Testing,COVID-19 Diagnostic Testing,COVID-19 Virus Testing,COVID19 Testing,COVID19 Virus Testing,Coronavirus Disease 2019 Testing,Coronavirus Disease-19 Testing,SARS Coronavirus 2 Testing,SARS-CoV-2 Testing,Severe Acute Respiratory Syndrome Coronavirus 2 Testing,2019 nCoV Disease Testing,2019 nCoV Infection Testing,2019 nCoV Testing,2019-nCoV Disease Testings,2019-nCoV Infection Testings,2019-nCoV Testings,COVID 19 Diagnostic Testing,COVID 19 Testing,COVID 19 Virus Testing,COVID-19 Diagnostic Testings,COVID-19 Testings,COVID-19 Virus Testings,COVID19 Testings,COVID19 Virus Testings,Coronavirus Disease 19 Testing,Coronavirus Disease-19 Testings,Diagnostic Testing, COVID-19,Disease Testing, 2019-nCoV,Infection Testing, 2019-nCoV,SARS CoV 2 Testing,SARS-CoV-2 Testings,Testing, 2019-nCoV,Testing, 2019-nCoV Disease,Testing, 2019-nCoV Infection,Testing, COVID-19,Testing, COVID-19 Virus,Testing, COVID19,Testing, COVID19 Virus,Testing, Coronavirus Disease-19,Testing, SARS-CoV-2,Virus Testing, COVID-19,Virus Testing, COVID19
D000914 Antibodies, Viral Immunoglobulins produced in response to VIRAL ANTIGENS. Viral Antibodies
D012680 Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) Specificity,Sensitivity,Specificity and Sensitivity
D012698 Serologic Tests Diagnostic procedures involving immunoglobulin reactions. Serodiagnosis,Serologic Test,Serological Tests,Test, Serologic,Tests, Serologic,Serodiagnoses,Serological Test,Test, Serological,Tests, Serological
D057134 Antibodies, Neutralizing Antibodies that reduce or abolish some biological activity of a soluble antigen or infectious agent, usually a virus. Neutralizing Antibodies,Antibody, Neutralizing,Neutralizing Antibody

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