Commercial Serology Assays Predict Neutralization Activity against SARS-CoV-2
| Autor: | Michael J. Kelner, Jenny Tuyet Tran, David Nemazee, James E. Voss, Deli Huang, Melissa A Hoffman, Raymond T. Suhandynata, Robert L. Fitzgerald, Ronald W. McLawhon, Sharon L. Reed |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Male Clinical Biochemistry Medical Biotechnology Prevalence serology Medical Biochemistry and Metabolomics Antibodies Viral Polymerase Chain Reaction Neutralization law.invention Serology Cohort Studies 0302 clinical medicine law Medicine 030212 general & internal medicine Viral skin and connective tissue diseases Neutralizing antibody Neutralizing General Clinical Medicine Polymerase chain reaction biology virus diseases respiratory system Middle Aged Titer Infectious Diseases Severe acute respiratory syndrome-related coronavirus Regression Analysis Female Antibody Adult Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Clinical Sciences Article Antibodies COVID-19 Serological Testing Vaccine Related 03 medical and health sciences Biodefense Humans neutralizing antibodies Retrospective Studies Aged Biochemistry medical business.industry SARS-CoV-2 Prevention Biochemistry (medical) fungi Immunity COVID-19 Antibodies Neutralizing Virology immunity body regions 030104 developmental biology Emerging Infectious Diseases Good Health and Well Being biology.protein Neutralizing Antibodies False positive rate business |
| Zdroj: | Clinical chemistry, vol 67, iss 2 Clinical Chemistry |
| Popis: | BackgroundCurrently it is unknown whether a positive serology results correlates with protective immunity against SARS-CoV-2. There are also concerns regarding the low positive predictive value of SARS-CoV-2 serology tests, especially when testing populations with low disease prevalence.MethodsA neutralization assay was validated in a set of PCR confirmed positive specimens and in a negative cohort. 9,530 specimens were screened using the Diazyme SARS-CoV-2 IgG serology assay and all positive results (N=164) were reanalyzed using the neutralization assay, the Roche total immunoglobin assay, and the Abbott IgG assay. The relationship between the magnitude of a positive SARS-CoV-2 serology result and the levels of neutralizing antibodies detected was correlated. Neutralizing antibody titers (ID50) were also longitudinally monitored in SARS-CoV-2 PCR confirmed patients.ResultsThe SARS-CoV-2 neutralization assay had a PPA of 96.6% with a SARS-CoV-2 PCR test and a NPA of 98.0% across 100 negative controls. ID50 neutralization titers positively correlated with all three clinical serology platforms. Longitudinal monitoring of hospitalized PCR confirmed COVID-19 patients demonstrates they made high neutralization titers against SARS-CoV-2. PPA between the Diazyme IgG assay alone and the neutralization assay was 50.6%, while combining the Diazyme IgG assay with either the Roche or Abbott platforms increased the PPA to 79.2% and 78.4%, respectively.ConclusionsFor the first time, we demonstrate that three widely available clinical serology assays positively correlate with SARS-CoV-2 neutralization activity observed in COVID-19 patients. When a two-platform screen and confirm approach was used for SARS-CoV-2 serology, nearly 80% of two-platform positive specimens had neutralization titers (ID50 >50).SummaryClinical performance of a SARS-CoV-2 neutralization assay was evaluated using SARS-CoV-2 PCR confirmed patients and SARS-CoV-2 negative individuals. The neutralization assay was compared with results from SARS-CoV-2 positive serology specimens. We demonstrate that positive SARS-CoV-2 serology results correlate with the presence of neutralization activity against SARS-CoV-2. We show a high false positive rate when using a single SARS-CoV-2 serology platform to screen populations with low disease prevalence; and confirm that using a two-platform approach for COVID-19 seropositives greatly improves positive predictive value for neutralization. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|