Commercial Serology Assays Predict Neutralization Activity against SARS-CoV-2.

Clinical Chemistry
Raymond T SuhandynataRobert L Fitzgerald

Abstract

It is unknown whether a positive serology result 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. A neutralization assay was validated in a set of PCR-confirmed positive specimens and in a negative cohort. In addition, 9530 specimens were screened using the Diazyme SARS-CoV-2 IgG serology assay and all positive results (N = 164 individuals) 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 neutralizing activity was determined. Neutralizing antibody titers (50% inhibitory dilution, ID50) were also longitudinally monitored in patients confirmed to have SARS-CoV-2 by PCR. The SARS-CoV-2 neutralization assay had a positive percentage agreement (PPA) of 96.6% with a SARS-CoV-2 PCR test and a negative percentage agreement (NPA) of 98.0% across 100 negative control individuals. ID50 neutralization titers positively correlated with all 3 clinical serology platforms. Longitudinal monitoring of hospitalized PCR-confirmed patients...Continue Reading

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Citations

Feb 25, 2021·Practical Laboratory Medicine·Cristina InterianoVan Leung-Pineda
Jun 3, 2021·Clinical Chemistry·Ronald W McLawhon, Robert L Fitzgerald
Jun 30, 2021·The Journal of Immunology : Official Journal of the American Association of Immunologists·Deli HuangDavid Nemazee
Jul 13, 2021·The Pediatric Infectious Disease Journal·Pembe Derin OygarMehmet Ceyhan
Jun 26, 2021·The Journal of Applied Laboratory Medicine·Raymond T SuhandynataRobert L Fitzgerald
Sep 3, 2021·Clinical Chemistry and Laboratory Medicine : CCLM·Massimo FranchiniClaudia Glingani
Jul 4, 2021·Transfusion·Christopher W FarnsworthJeffrey P Henderson

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