Terpos Evangelos, Ntanasis-Stathopoulos Ioannis, Skvarč Miha
Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra General Hospital, PS 11528 Athens, Greece.
Clinical Trial Institution, General Hospital Jesenice, PS 4270 Jesenice, Slovenia.
Diagnostics (Basel). 2021 May 30;11(6):995. doi: 10.3390/diagnostics11060995.
The precise diagnosis of COVID-19 is of outmost importance in order to effectively treat patients and prevent SARS-CoV-2 transmission. Herein, we evaluated the sensitivity and specificity of the COVID-19 Antigen Detection Kit (Colloidal Gold-CG) compared with PCR in nasopharyngeal and nasal samples. A total of 114 positive and 244 negative nasopharyngeal specimens confirmed by PCR were used in this comparative study. When the PCR positive Cycle Threshold (Ct) value was ≤25, CG sensitivity was 100%. When the PCR positive Ct value was ≤33, CG sensitivity was 99%. When the PCR positive Ct value was ≤40, CG sensitivity was 89.47%. Regarding nasal swabs, a total of 109 positive and 250 negative specimens confirmed by PCR were used. When the PCR positive Ct value was ≤25, CG sensitivity was 100%. When the PCR positive Ct value was ≤33, CG sensitivity was 96.12%. When the PCR positive Ct value was ≤37, CG sensitivity was 91.74%. Specificity was above 99% regardless of the Ct value of PCR positivity for both nasopharyngeal and nasal specimens. Overall, the CG showed high sensitivity and specificity when the PCR Ct value was less than 33. Therefore, CG can be used for screening early in the disease course. Confirmatory PCR is essential when a false negative result is suspected.
为有效治疗患者并预防新冠病毒传播，准确诊断新型冠状病毒肺炎（COVID-19）至关重要。在此，我们评估了新冠病毒抗原检测试剂盒（胶体金法-CG）在鼻咽和鼻腔样本中与聚合酶链反应（PCR）相比的敏感性和特异性。本对比研究共使用了114份经PCR确诊的鼻咽阳性样本和244份阴性样本。当PCR阳性循环阈值（Ct）值≤25时，CG的敏感性为100%。当PCR阳性Ct值≤33时，CG的敏感性为99%。当PCR阳性Ct值≤40时，CG的敏感性为89.47%。对于鼻拭子，共使用了109份经PCR确诊的阳性样本和250份阴性样本。当PCR阳性Ct值≤25时，CG的敏感性为100%。当PCR阳性Ct值≤33时，CG的敏感性为96.12%。当PCR阳性Ct值≤37时，CG的敏感性为91.74%。无论鼻咽和鼻样本PCR阳性的Ct值如何，特异性均高于99%。总体而言，当PCR Ct值小于33时，CG显示出高敏感性和特异性。因此，CG可用于病程早期的筛查。当怀疑出现假阴性结果时，进行确诊性PCR检测至关重要。
