Younes Nadin, Al-Sadeq Duaa W, Shurrab Farah M, Zedan Hadeel T, Abou-Saleh Haissam, Abo-Halawa Bushra Y, AlHamaydeh Fatima M, Elsharafi Amira E, Daas Hanin I, Thomas Swapna, Aboalmaaly Sahar, Al Farsi Afra, Al-Buainain Reeham, Ataelmannan Samar, Paul Jiji, Al Saadi Amana Salih, Yassine Hadi M, Majdalawieh Amin F, Ismail Ahmed, Abu-Raddad Laith J, Nasrallah Gheyath K
Biomedical Research Center, Qatar University, Doha 2713, Qatar.
Department of Biomedical Science, College of Health Sciences, QU Health, Qatar University, Doha 2713, Qatar.
Vaccines (Basel). 2022 Aug 15;10(8):1318. doi: 10.3390/vaccines10081318.
Background: Limited commercial LFA assays are available to provide a reliable quantitative measurement of the total binding antibody units (BAU/mL) against the receptor-binding domain of the SARS-CoV-2 spike protein (S-RBD). Aim: This study aimed to evaluate the performance of the fluorescence LFA FinecareTM 2019-nCoV S-RBD test along with its reader (Model No.: FS-113) against the following reference methods: (i) the FDA-approved GenScript surrogate virus-neutralizing assay (sVNT); and (ii) three highly performing automated immunoassays: BioMérieux VIDAS®3, Ortho VITROS®, and Mindray CL-900i®. Methods: Plasma from 488 vaccinees was tested by all aforementioned assays. Fingerstick whole-blood samples from 156 vaccinees were also tested by FinecareTM. Results and conclusions: FinecareTM showed 100% specificity, as none of the pre-pandemic samples tested positive. Equivalent FinecareTM results were observed among the samples taken from fingerstick or plasma (Pearson correlation r = 0.9, p < 0.0001), suggesting that fingerstick samples are sufficient to quantitate the S-RBD BAU/mL. A moderate correlation was observed between FinecareTM and sVNT (r = 0.5, p < 0.0001), indicating that FinecareTM can be used for rapid prediction of the neutralizing antibody (nAb) post-vaccination. FinecareTM BAU results showed strong correlation with VIDAS®3 (r = 0.6, p < 0.0001) and moderate correlation with VITROS® (r = 0.5, p < 0.0001) and CL-900i® (r = 0.4, p < 0.0001), suggesting that FinecareTM can be used as a surrogate for the advanced automated assays to measure S-RBD BAU/mL.
可用于可靠定量测定针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）刺突蛋白受体结合域（S-RBD）的总结合抗体单位（BAU/mL）的商业化侧向流动分析（LFA）检测方法有限。目的：本研究旨在评估荧光LFA FinecareTM 2019-nCoV S-RBD检测及其读数仪（型号：FS-113）相对于以下参考方法的性能：（i）美国食品药品监督管理局（FDA）批准的金斯瑞替代病毒中和试验（sVNT）；以及（ii）三种高性能自动化免疫分析方法：生物梅里埃VIDAS®3、奥森VITROS®和迈瑞CL-900i®。方法：采用上述所有检测方法对488名疫苗接种者的血浆进行检测。还采用FinecareTM对156名疫苗接种者的指尖全血样本进行检测。结果与结论：FinecareTM显示出100%的特异性，因为大流行前的样本均未检测为阳性。在指尖或血浆采集的样本中观察到FinecareTM结果相当（皮尔逊相关系数r = 0.9，p < 0.0001），表明指尖样本足以定量S-RBD BAU/mL。在FinecareTM和sVNT之间观察到中度相关性（r = 0.5，p < 0.0001），表明FinecareTM可用于疫苗接种后中和抗体（nAb）的快速预测。FinecareTM的BAU结果与VIDAS®3显示出强相关性（r = 0.6，p < 0.0001），与VITROS®显示出中度相关性（r = 0.5，p < 0.0001），与CL-900i®显示出中度相关性（r = 0.4，p < 0.0001），表明FinecareTM可作为先进自动化检测方法的替代方法来测量S-RBD BAU/mL。
