期刊
TRANSFUSION
卷 61, 期 4, 页码 1171-1180出版社
WILEY
DOI: 10.1111/trf.16327
关键词
Infectious disease testing; intravenous immunoglobulin; kodecyte
类别
资金
- NZ Ministry of Business, Innovation & Employment COVID-19 Innovation Acceleration Fund [CIAF 0490]
- NIH Intramural Research Program at the NIH Clinical Center [ZIA CL002128, RASCL727301]
- Russian Foundation for Basic Research [20-04-60335]
This study evaluated the feasibility of using SARS-CoV-2 peptide Kode Technology-modified red cells to develop an assay for detecting SARS-CoV-2 antibodies. The results showed that C19-kodecytes have high specificity and sensitivity on routine serologic platforms, making them suitable for serological testing related to COVID-19.
Background The Coronavirus disease 2019 (COVID-19) pandemic is having a major global impact, and the resultant response in the development of new diagnostics is unprecedented. The detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has a role in managing the pandemic. We evaluated the feasibility of using SARS-CoV-2 peptide Kode Technology-modified red cells (C19-kodecytes) to develop an assay compatible with existing routine serologic platforms. Study Design and Methods A panel of eight unique red cells modified using Kode Technology function-spacer-lipid constructs and bearing short SARS-CoV-2 peptides was developed (C19-kodecyte assay). Kodecytes were tested against undiluted expected antibody-negative and -positive plasma samples in manual tube and three column agglutination technology (CAT) platforms. Parallel analysis with the same peptides in solid phase by enzyme immunoassays was performed. Evaluation samples included >120 expected negative blood donor samples and >140 COVID-19 convalescent plasma samples, with independent serologic analysis from two centers. Results Specificity (negative reaction rate against expected negative samples) in three different CAT platforms against novel C19-kodecytes was >91%, which correlated with published literature. Sensitivity (positive reaction rate against expected positive convalescent, PCR-confirmed samples) ranged from 82% to 97% compared to 77% with the Abbott Architect SARS-CoV-2 IgG assay. Manual tube serology was less sensitive than CAT. Enzyme immunoassay results with some Kode Technology constructs also had high sensitivity. Conclusions C19-kodecytes are viable for use as serologic reagent red cells for the detection of SARS-CoV-2 antibody with routine blood antibody screening equipment.
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