通过侧向流动纳米颗粒荧光免疫测定法评估新型冠状病毒 2 型总抗体检测
Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay.
作者信息
Sibai Mamdouh, Solis Daniel, Röltgen Katharina, Stevens Bryan A, Mfuh Kenji O, Sahoo Malaya K, Shi Run Z, Zehnder James, Boyd Scott D, Pinsky Benjamin A
机构信息
Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA; Clinical Virology Laboratory, Stanford Health Care, Stanford, CA, USA.
出版信息
J Clin Virol. 2021 Jun;139:104818. doi: 10.1016/j.jcv.2021.104818. Epub 2021 Apr 1.
BACKGROUND
The coronavirus disease 2019 (COVID-19) endgame may benefit from simple, accurate antibody testing to characterize seroprevalence and immunization coverage.
OBJECTIVES
To evaluate the performance of the lateral flow QIAreach anti-SARS-CoV-2 Total rapid nanoparticle fluorescence immunoassay compared to reference isotype-specific IgG, IgM, and IgA SARS-CoV-2 ELISA using S1 or receptor binding domain (RBD) as antigens.
STUDY DESIGN
A diagnostic comparison study was carried out using 154 well-characterized heparin plasma samples. Agreement between assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient.
RESULTS
Overall agreement between the QIAreach anti-SARS-CoV-2 Total and any anti-spike domain (S1 or RBD) antibody isotype was 96.0 % (95 % CI 89.8-98.8), the positive percent agreement was 97.6 % (95 % CI 91.0-99.9), the negative percent agreement was 88.2 % (95 % CI 64.4-98.0). The kappa coefficient was 0.86 (95 % CI 0.72 to 0.99).
CONCLUSION
The QIAreach anti-SARS-CoV-2 Total rapid antibody test provides comparable performance to high-complexity, laboratory-based ELISA.
背景
2019年冠状病毒病（COVID-19）的最终阶段可能受益于简单、准确的抗体检测，以确定血清流行率和免疫覆盖率。
目的
与使用S1或受体结合域（RBD）作为抗原的参考同种型特异性IgG、IgM和IgA SARS-CoV-2 ELISA相比，评估侧向流动QIAreach抗SARS-CoV-2总快速纳米颗粒荧光免疫测定的性能。
研究设计
使用154份特征明确的肝素血浆样本进行诊断比较研究。通过总体、阳性和阴性百分比一致性以及科恩kappa系数评估检测之间的一致性。
结果
QIAreach抗SARS-CoV-2总检测与任何抗刺突域（S1或RBD）抗体同种型之间的总体一致性为96.0%（95%CI 89.8-98.8），阳性百分比一致性为97.6%（95%CI 91.0-99.9），阴性百分比一致性为88.2%（95%CI 64.4-98.0）。kappa系数为0.86（95%CI 0.72至0.99）。
结论
QIAreach抗SARS-CoV-2总快速抗体检测与基于实验室的高复杂性ELISA具有相当的性能。
Zotero 插件