Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals.
Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals.
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DOI：
10.1016/j.jiac.2021.07.005
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发表时间：
2021-10
期刊：
影响因子：
--
通讯作者：
Suzuki H
中科院分区：
文献类型：
--
作者：
Kiyasu Y;Takeuchi Y;Akashi Y;Kato D;Kuwahara M;Muramatsu S;Notake S;Ueda A;Nakamura K;Ishikawa H;Suzuki H
抗原检测可能有助于筛查和检测无症状个体中的严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染。然而，关于这一群体的抗原检测的诊断性能的数据有限。我们使用临床样本前瞻性地评估了抗原检测QuickNavi™-CoVID19Ag的分析和临床性能。这项研究是在2020年10月7日至2021年1月9日期间在一个聚合酶链式反应中心进行的。每名患者取两份鼻咽标本，一份用于抗原检测，另一份用于实时逆转录聚合酶链式反应(RT-PCR)。比较抗原检测在无症状患者和有症状患者之间的诊断性能，并以RT-PCR结果为参考。在收集的1934份样本中，188份(9.7%)标本实时定量RT-PCR检测到SARS-CoV-2，其中76份(40.4%)来自无症状个体，半数以上的样本(1073份；55.5%)无症状。抗原检测对无症状组的敏感度显著低于有症状组(分别为67.1%和89.3%，P<0.001)。两组的特异度均为100%，所有1934份样本均未观察到假阳性。无症状组的周期阈值中位数显著高于有症状组(24比20，P<0.001)。QuickNavi™-CoVID19Ag对无症状组的敏感性低于有症状患者。然而，其特异性一直很高，在本研究中未发现假阳性。
Antigen testing may help screen for and detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in asymptomatic individuals. However, limited data regarding the diagnostic performance of antigen tests for this group are available. We used clinical samples to prospectively evaluate the analytical and clinical performance of the antigen test QuickNavi™-COVID19 Ag. This study was conducted at a PCR center between October 7, 2020 and January 9, 2021. Two nasopharyngeal samples per patient were obtained with flocked swabs; one was used for the antigen test, and the other for real-time reverse transcription PCR (RT-PCR). The diagnostic performance of the antigen test was compared between asymptomatic and symptomatic patients, and the RT-PCR results were used as a reference. Among the 1934 collected samples, 188 (9.7%) demonstrated detection of SARS-CoV-2 by real-time RT-PCR; 76 (40.4%) of these 188 samples were from asymptomatic individuals, and over half of the total samples were asymptomatic (1073; 55.5%). The sensitivity of the antigen test was significantly lower for the asymptomatic group than for symptomatic patients (67.1% vs. 89.3%, respectively, p < 0.001). The specificity was 100% for both groups, and no false positives were observed among all 1934 samples. The median cycle threshold value for the asymptomatic group was significantly higher than that of the symptomatic group (24 vs. 20, p < 0.001). The QuickNavi™-COVID19 Ag showed lower sensitivity for the asymptomatic group than for symptomatic patients. However, its specificity was consistently high, and no false positives were found in this study.
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