Rapid cassette test results in anti-SARS-CoV-2 antibody screening verification by electrochemiluminescence immunoassay method

Nazife Akman, Zeynep Akidagi, Pelin Özmen, Rukiye Yalap
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Abstract

Objective: Since the resumption of face-to-face education in October 2020, which was suspended due to the COVID-19 pandemic, coincides with the period when SARS-CoV-2 infection rates in young adults are on the rise. This study focuses on the 2019 corona virus outbreak in young adults, the largest link in the chain of transmission, which can be defined as silent contagious agents. It is aimed to provide epidemiological data by detecting virus disease (COVID-19) seropositivity with two different serological methods, and to evaluate the symptom-test performance relationship of asymptomatic/mild symptom/symptomatic cases. Methods: A cross-sectional study was conducted with students studying at Cappadocia University health programs between December 2020 and February 2021 and who will attend practice courses face-to-face. Participants were surveyed about their COVID-19 symptoms and disease histories based on SARS-CoV-2 exposure. For SARS-CoV-2 antibody detection, blood samples were taken from the participants and investigated with a single lateral flow immunoAssay (LFIA, Novatech, Turkey) cassette test. The samples with positive test result were then SARS-CoV-2 Anti-N IgM+IgG;SARS-CoV-2 Anti-S IgM+IgG;SARS-CoV-2 Anti-RBD IgG;It was re-evaluated using the electrochemiluminescence immunoassay (ECLIA) method with the anti-SARS-CoV-2 kit (Roche, Germany). Results: Of the 239 samples participating in the study, 50 (20.9%) samples that were positive for SARS-CoV2 IgM/ IgG according to the LFIA method were then studied again with the ECLIA method. According to the ECLIA result, 72% (36/50) of individuals against both nucleocapsid (N) and spike (S) antigens, and 70% (35) against RBD antigen were seropositive. Based on the ECLIA test results, 239 samples were studied and 50 samples were found to be IgM/IgG positive, with a sensitivity of 64% and a specificity of 93%. Contingence history was reported in 46% (n=23) of patients who were seropositive by both methods, while 30% (n=15) showed a COVID-19 clinic. Fifty four percent (n=27) of the participants reported that they did not have a PCR (polymerase chain reaction) test, but antibody response was observed in all of them. Only 28% (n=14) of seropositive patients reported positive PCR results, and 4% of them stated that they had a chronic disease. It will be important to continue to observe the serological status of young people, particularly in the context of new COVID-19 variants and in the low interest in mass vaccination campaigns targeting young people. Conclusion: It is thought that the performance of ECLIA with rapid casette test does not have a good degree of agreement and confirmation with different immunoassay tests would be more useful for epidemiological surveillance. Especially the new COVID-19 in the context of the variants and targeting youth due to the lack of interest in vaccination champaigns continue to monitor the serological status of young people it will be important.
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电化学发光免疫分析法抗sars - cov -2抗体筛选验证的快速盒式试验结果
目的:自2020年10月恢复因新冠肺炎大流行而暂停的面授教育以来,恰逢青年sars - cov感染率上升时期。这项研究的重点是2019年冠状病毒在年轻人中的爆发,这是传播链中最大的一环,可以定义为沉默的传染性病原体。目的通过两种不同的血清学方法检测新冠病毒病(COVID-19)血清阳性,提供流行病学资料,评价无症状/轻度症状/有症状病例的症状-检测绩效关系。方法:对2020年12月至2021年2月在卡帕多西亚大学健康专业学习的学生进行了一项横断面研究,这些学生将参加面对面的实践课程。根据SARS-CoV-2暴露情况,调查了参与者的COVID-19症状和病史。对于SARS-CoV-2抗体检测,从参与者身上采集血液样本,并使用单侧流动免疫分析法(LFIA, Novatech,土耳其)盒式试验进行调查。检测结果阳性的样品分别检测SARS-CoV-2 Anti-N IgM+IgG、SARS-CoV-2 Anti-S IgM+IgG、SARS-CoV-2 Anti-RBD IgG,使用德国罗氏公司anti- cov -2试剂盒,采用电化学发光免疫分析法(ECLIA)重新评价。结果239份样本中,50份(20.9%)经LFIA法检测为SARS-CoV2 IgM/ IgG阳性的样本用ECLIA法再次检测。ECLIA结果显示,72%(36/50)的个体对核衣壳(N)和刺突(S)抗原均呈血清阳性,70%(35)的个体对RBD抗原均呈血清阳性。根据ECLIA检测结果,239份样本进行了研究,其中50份为IgM/IgG阳性,敏感性为64%,特异性为93%。两种方法血清均呈阳性的患者中,46% (n=23)报告了偶然病史,30% (n=15)出现了COVID-19临床。54% (n=27)的参与者报告说他们没有进行PCR(聚合酶链反应)测试,但在所有参与者中都观察到抗体反应。只有28% (n=14)的血清阳性患者报告PCR结果阳性,其中4%的患者表示他们患有慢性疾病。重要的是继续观察年轻人的血清学状况,特别是在出现新的COVID-19变体以及对针对年轻人的大规模疫苗接种运动兴趣不高的情况下。结论:ECLIA与快速盒试验结果的一致性程度不高,与不同免疫测定方法的确认对流行病学监测更有帮助。特别是在新型COVID-19变异和针对年轻人的背景下,由于缺乏对疫苗接种运动的兴趣,继续监测年轻人的血清学状况将是重要的。
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