Diani Erica, Piccaluga Pier Paolo, Lotti Virginia, Di Clemente Andrea, Ligozzi Marco, De Nardo Pasquale, Lambertenghi Lorenza, Pizzolo Francesca, Friso Simonetta, Lo Cascio Giuliana, Vianello Alice, Marchi Giacomo, Concia Ercole, Gibellini Davide
Department of Diagnostics and Public Health, Microbiology Section, University of Verona, Italy.
Department of Experimental, Diagnostic, and Experimental Medicine, Bologna University School of Medicine, Bologna, Italy.
Heliyon. 2021 Oct;7(10):e08192. doi: 10.1016/j.heliyon.2021.e08192. Epub 2021 Oct 19.
The dramatic impact of SARS-CoV-2 infection on the worldwide public health has elicited the rapid assessment of molecular and serological diagnostic methods. Notwithstanding the diagnosis of SARS-CoV-2 infection is based on molecular biology approaches including multiplex or singleplex real time RT-PCR, there is a real need for affordable and rapid serological methods to support diagnostics, and surveillance of infection spreading. In this study, we performed a diagnostic accuracy analysis of COVID-19 IgG/IgM rapid test cassette lateral flow immunoassay test (LFIA) assay. To do so, we analyzed different cohorts of blood samples obtained from 151 SARS-CoV-2 RT-PCR assay positive patients (group 1) and 51 SARS-CoV-2 RT-PCR assay negative patients (group 2) in terms of sensitivity, specificity, PPV, NPV and likelihood ratios. In addition, we challenged LFIA with plasma from 99 patients stored during 2015-2017 period. Our results showed that this LFIA detected SARS-CoV-2 IgM and/or IgG in 103 out of 151 (68.21%) samples of group 1, whereas no IgM and/or IgG detection was displayed both in the group 2 and in pre-pandemic samples. Interestingly, IgM and/or IgG positivity was detected in 86 out of 94 (91.49%) group 1 samples collected after 10 days from symptoms onset whereas only 17 out of 57 of group 1 samples obtained before day 10 were positive to SARS-CoV-2 specific antibodies. We also compared the performance of this LFIA test with respect to other four different LFIA assays in 40 serum samples from multiplex RT-PCR positive individuals. Within the limits of the study size, the results demonstrated that COVID-19 IgG/IgM rapid test cassette LFIA assay displayed valid performance in IgM and IgG detection when compared with the other four LFIA assays. Hence, this approach might be considered as an alternative point-of-care procedure for SARS-CoV-2 serological investigation.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染对全球公共卫生产生了巨大影响，这促使人们迅速评估分子和血清学诊断方法。尽管SARS-CoV-2感染的诊断基于包括多重或单重实时逆转录聚合酶链反应（RT-PCR）在内的分子生物学方法，但确实需要经济实惠且快速的血清学方法来辅助诊断以及监测感染传播情况。在本研究中，我们对新型冠状病毒肺炎（COVID-19）IgG/IgM快速检测试剂盒侧向流动免疫分析试验（LFIA）进行了诊断准确性分析。为此，我们从151例SARS-CoV-2 RT-PCR检测呈阳性的患者（第1组）和51例SARS-CoV-2 RT-PCR检测呈阴性的患者（第2组）获取不同队列的血液样本，分析了其敏感性、特异性、阳性预测值、阴性预测值和似然比。此外，我们用99例在2015年至2017年期间储存的患者的血浆对LFIA进行了测试。我们的结果显示，该LFIA在第1组的151份样本中的103份（68.21%）中检测到了SARS-CoV-2 IgM和/或IgG，而第2组和大流行前的样本均未检测到IgM和/或IgG。有趣的是，在症状出现后10天采集的第1组94份样本中的86份（91.49%）检测到了IgM和/或IgG阳性，而在第1组第10天之前获取的57份样本中只有17份对SARS-CoV-2特异性抗体呈阳性。我们还在来自多重RT-PCR阳性个体的40份血清样本中，将该LFIA检测的性能与其他四种不同的LFIA检测进行了比较。在本研究规模的限制范围内，结果表明，与其他四种LFIA检测相比时COVID-19 IgG/IgM快速检测试剂盒LFIA检测在IgM和IgG检测方面表现出有效的性能。因此，这种方法可被视为SARS-CoV-2血清学调查的一种床旁检测替代方法
