Biomedical Research Center, Qatar University, 2713, Doha, Qatar.
Biomedical Research Center, Qatar University, 2713, Doha, Qatar; Department of Biomedical Science, College of Health Sciences, Member of QU Health, Qatar University, 2713, Doha, Qatar.
Int J Infect Dis. 2022 May;118:132-137. doi: 10.1016/j.ijid.2022.02.052. Epub 2022 Feb 26.
A vast majority of the commercially available lateral flow immunoassay (LFIA) is used to detect SARS-CoV-2 antibodies qualitatively. Recently, a novel fluorescence-based lateral flow immunoassay (LFIA) test was developed for quantitative measurement of the total binding antibody units (BAUs) (BAU/mL) against SARS-CoV-2 spike protein receptor-binding domain (S-RBD).
This study aimed to evaluate the performance of the fluorescence LFIA Finecare 2019-nCoV S-RBD test along with its reader (Model No.: FS-113).
Plasma from 150 reverse trancriptase-PCR (RT-PCR)-confirmed positive individuals and 100 prepandemic samples were tested by Fincare to access sensitivity and specificity. For qualitative and quantitative validation of the FinCare measurements, BAU/mL results of FinCare were compared with results of 2 reference assays: the surrogate virus-neutralizing test (sVNT, GenScript Biotech, USA) and the VIDAS®3 automated assay (BioMérieux, France).
Finecare showed 92% sensitivity and 100% specificity compared with PCR. Cohen's Kappa statistic denoted moderate and excellent agreement with sVNT and VIDAS®3, with values being 0.557 (95% CI: 0.32-0.78) and 0.731 (95% CI: 0.51-0.95), respectively. A strong correlation was observed between Finecare/sVNT (r = 0.7, p < 0.0001) and Finecare/VIDAS®3 (r = 0.8, p < 0.0001).
Finecare is a reliable assay and can be used as a surrogate to assess binding and neutralizing antibody response after infection or vaccination, particularly in none or small laboratory settings.
绝大多数市售侧向流动免疫分析（LFIA）用于定性检测 SARS-CoV-2 抗体。最近，开发了一种新型荧光基于侧向流动免疫分析（LFIA）测试，用于定量测量针对 SARS-CoV-2 刺突蛋白受体结合域（S-RBD）的总结合抗体单位（BAU）（BAU/mL）。
本研究旨在评估荧光 LFIA Finecare 2019-nCoV S-RBD 测试及其阅读器（型号：FS-113）的性能。
使用 Fincare 测试了 150 例逆转录酶聚合酶链反应（RT-PCR）确诊阳性个体和 100 例大流行前样本，以评估灵敏度和特异性。为了对 Finecare 的测量进行定性和定量验证，将 Finecare 的 BAU/mL 结果与两种参考测定法的结果进行比较：替代病毒中和试验（sVNT，美国 GenScript Biotech）和 VIDAS®3 自动化测定法（法国 BioMérieux）。
与 PCR 相比，Finecare 的敏感性为 92%，特异性为 100%。科恩氏 Kappa 统计数据表示与 sVNT 和 VIDAS®3 具有中等和极好的一致性，值分别为 0.557（95%CI：0.32-0.78）和 0.731（95%CI：0.51-0.95）。Finecare/sVNT（r=0.7，p<0.0001）和 Finecare/VIDAS®3（r=0.8，p<0.0001）之间观察到强相关性。
Finecare 是一种可靠的测定法，可用于评估感染或接种疫苗后的结合和中和抗体反应，特别是在无或小型实验室环境中。
