Clinical performance of the Panbio assay for the detection of SARS-CoV-2 IgM and IgG in COVID-19 patients
Clinical performance of the Panbio assay for the detection of SARS-CoV-2 IgM and IgG in COVID-19 patients
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DOI：
10.1002/jmv.26884
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发表时间：
2021-03-01
影响因子：
12.7
通讯作者：
Favresse, Julien
中科院分区：
文献类型：
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作者：
Haguet, Helene;Douxfils, Jonathan;Favresse, Julien
在严重急性呼吸综合征冠状病毒2(SARS-CoV-2)大流行之后，发展了许多血清学检测，包括快速诊断检测。本研究旨在评估新冠肺炎试验(Abbott)的临床应用性能，该试验是一种快速侧向流动试验，用于定性检测SARS-CoV-2的免疫球蛋白G和免疫球蛋白M。对95例SARS-CoV-2逆转录聚合酶链式反应阳性的新冠肺炎患者的138份标本进行检测，以评估其临床敏感性。用76份新冠肺炎前样本评价其临床特异性。两个独立的盲评分员在10分钟和20分钟后用肉眼确定每个测试中是否存在免疫球蛋白、免疫球蛋白M和控制线。症状出现后14天以上采集的标本对免疫球蛋白的敏感性为95.2%。IgM的检出频率较低(最高敏感度为20.5%)。特异性分别为98.7%和100%。此外，当读数在20min时比在10min时灵敏度更高，而特异性没有变化。Panbio新冠肺炎免疫球蛋白/免疫球蛋白M快速检测方法检测免疫球蛋白具有较高的敏感性，但对免疫球蛋白的敏感性较低。免疫球蛋白G和免疫球蛋白M均具有良好的特异性。
Following the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, numerous serological tests have been developed, including rapid diagnostic tests. This study aims at assessing the clinical performance of the Panbio immunoglobulin G (IgG)/IgM coronavirus disease 2019 (COVID-19) test (Abbott), a rapid lateral flow assay for the qualitative detection of IgG and IgM against SARS-CoV-2. One hundred and thirty-eight samples from 95 COVID-19 patients with a positive SARS-CoV-2 reverse-transcriptase polymerase chain reaction were analyzed to assess the clinical sensitivity. Seventy-six pre-COVID-19 samples were used to evaluate the clinical specificity. Two independent and blinded raters determined visually the presence or absence of the IgG, IgM, and control lines for each test after 10 and 20 min. The sensitivity obtained from collected samples more than 14 days after the onset of symptoms was 95.2% for IgG. IgM was less frequently detected (highest sensitivity of 20.5%). The specificities obtained were 98.7% and 100% for IgG and IgM, respectively. In addition, the sensitivity of the assay was better when the reading was performed at 20 min than at 10 min, whereas the specificity was unchanged. The Panbio COVID-19 IgG/IgM rapid test detects IgG with high sensitivity 14 days since symptom onset but presents a low sensitivity for IgM. The specificity was excellent for both IgG and IgM.