Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection.
Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection.
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DOI：
10.1016/j.cmi.2020.09.057
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发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Wu Y
中科院分区：
文献类型：
--
作者：
Diao B;Wen K;Zhang J;Chen J;Han C;Chen Y;Wang S;Deng G;Zhou H;Wu Y
能够适应严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)早期诊断的快速、可靠和易于实施的诊断方法是抗击疫情的关键。SARS-CoV-2核衣壳蛋白(NP)是病毒抗原检测的理想靶点。建立了一种基于荧光免疫层析(FIC)检测SARS-CoV-2 NP抗原的快速、简便的方法。然而，这种诊断方法的准确性需要检查。这项前瞻性研究于2020年2月10日至15日在武汉的7家医院和重庆的一家医院中国进行。纳入了临床疑似SARS-CoV-2感染的参与者。对同一鼻咽拭子标本同时进行荧光免疫印迹法检测NP抗原和实时逆转录聚合酶链式反应(RT-PCR)检测核酸。以RT-PCRNA检测为参照标准，以循环阈值(Ct)为40的样本为≤-CoV2阳性，计算NP抗原检测的准确性。共有253名参与者参加；两名参与者因NP测试结果无效而被排除在分析之外。在纳入诊断准确性分析的251名参与者(99.2%)中，201名(80.1%)的CT值为≤40。以Ct值40作为NA检测的界值，FIC法的灵敏度、特异度和符合率分别为75.6%(95%可信区间69.0~81.3)、100%(95%可信区间91.1~100)和80.5%(95%可信区间75.1~84.9)。以RT-PCR法为参照标准，FIC法检测NP抗原对SARS-CoV-2感染早期诊断具有较高的特异性和较高的敏感性。
Rapid, reliable and easy-to-implement diagnostics that can be adapted in early severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnosis are critical to combat the epidemic. SARS-CoV-2 nucleocapsid protein (NP) is an ideal target for viral antigen-based detection. A rapid and convenient method was developed based on fluorescence immunochromatographic (FIC) assay to detect the SARS-CoV-2 NP antigen. However, the accuracy of this diagnostic method needs to be examined. This prospective study was carried out between 10 and 15 February 2020 in seven hospitals in Wuhan and one hospital in Chongqing, China. Participants with clinically suspected SARS-CoV-2 infection were enrolled. NP antigen testing by FIC assay and nucleic acid (NA) testing by real-time reverse transcriptase PCR (RT-PCR) were performed simultaneously in a blinded manner with the same nasopharyngeal swab sample. The diagnostic accuracy of NP antigen testing was calculated by taking NA testing of RT-PCR as the reference standard, in which samples with a cycle threshold (Ct) value of ≤40 were interpreted as positive for SARS-CoV-2. A total of 253 participants were enrolled; two participants were excluded from the analyses because of invalid NP testing results. Of 251 participants (99.2%) included in the diagnostic accuracy analysis, 201 (80.1%) had a Ct value of ≤40. With Ct value 40 as the cutoff of NA testing, the sensitivity, specificity and percentage agreement of the FIC assay was 75.6% (95% confidence interval, 69.0–81.3), 100% (95% confidence interval, 91.1–100) and 80.5% (95% confidence interval, 75.1–84.9) respectively. With RT-PCR assay as the reference standard, NP antigen testing by FIC assay shows high specificity and relatively high sensitivity in SARS-CoV-2 diagnosis in the early phase of infection.
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