Centre for Kode Technology Innovation, School of Engineering, Computer and Mathematical Sciences, Faculty of Design and Creative Technologies, Auckland University of Technology, Auckland, New Zealand.
Department of Transfusion Medicine, NIH Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
Transfusion. 2021 Apr;61(4):1171-1180. doi: 10.1111/trf.16327. Epub 2021 Feb 25.
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.
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.
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.
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.
2019 年冠状病毒病（COVID-19）大流行正在产生重大的全球影响，因此前所未有地迅速开发出新的诊断方法。检测针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的抗体在管理大流行方面发挥了作用。我们评估了使用 SARS-CoV-2 肽 Kode 技术修饰的红细胞（C19-kodecyte）来开发与现有常规血清学平台兼容的检测方法的可行性。
开发了一组使用 Kode 技术功能间隔物脂质构建体修饰的 8 种独特的红细胞（C19-kodecyte 检测），这些红细胞上带有短的 SARS-CoV-2 肽。Kodecytes 在手动试管和三种柱凝集技术（CAT）平台上针对未经稀释的预期抗体阴性和阳性血浆样本进行了测试。同时在固相上通过酶免疫测定平行分析相同的肽。评估样本包括超过 120 份预期的阴性献血者样本和超过 140 份 COVID-19 恢复期血浆样本，由两个中心进行独立的血清学分析。
在三种不同的 CAT 平台上针对新型 C19-kodecytes 的特异性（阴性反应率对预期阴性样本）均>91%，与已发表的文献一致。与 Abbott Architect SARS-CoV-2 IgG 检测相比，敏感性（对预期阳性恢复期、PCR 确认样本的阳性反应率）范围为 82%至 97%。手动试管血清学的敏感性低于 CAT。一些 Kode 技术构建体的酶免疫测定结果也具有很高的敏感性。
C19-kodecytes 可用于作为血清学试剂红细胞，用于使用常规血液抗体筛选设备检测 SARS-CoV-2 抗体。
