The diagnostic value of rapid anti IgM and IgG detecting tests in the identification of patients with SARS CoV-2 virus infection
The diagnostic value of rapid anti IgM and IgG detecting tests in the identification of patients with SARS CoV-2 virus infection
复制标题
DOI：
10.1556/650.2020.31859
复制
发表时间：
2020-05-01
期刊：
影响因子：
0.6
通讯作者：
Merkely Bela
中科院分区：
文献类型：
--
作者：
Vasarhelyi Barna;Kristof Katalin;Merkely Bela
简介：2020 年 3 月底，匈牙利引入了检测是否存在针对 SARS-CoV-2 病毒的抗病毒 IgM 和 IgG 抗体的快速检测，用于识别 SARS-CoV-2 感染（COVID-19 疾病）。目的：我们评估了两种快速检测（安徽和 Clungene），与被认为是感染检测金标准的实时 PCR 检测进行比较。方法：3 月 16 日至 4 月 14 日之间， 2020年，我们进行了无需PCR的快速IgM和IgG检测测试； PCR 无需快速检测；分别对 4140 名、3210 名和 1654 名患者进行了 PCR 快速检测。 （在这1654名患者中，安徽和Clungene检测分别对625名和1029名患者进行了检测。）当任意时间出现PCR阳性和IgM或IgG阳性时，患者分别被认为是PCR和快速检测阳性。 （注：Clungene 检测也被称为“Lungene”。）结果：4864 名 PCR 检测患者中 PCR 阳性率为 6.3%。安徽和Clungene检测的敏感性和特异性分别为33.3%和72.85%、35.48%和85.02%。在6% PCR阳性率下，安徽和Clungene的阳性预测值和阴性预测值分别为7.28%、94.48%、13.13%和95.38%。结论：阳性预测值较低表明安徽和Clungene快速检测是否存在针对SARS-CoV-2病毒感染的抗IgM和抗IgG，不适合在普通人群中筛查SARS-CoV-2病毒感染。这些结果强烈支持安徽和 Clungene 检测 SARS-CoV-2 病毒 IgM 和 IgG 抗体的快速检测不应用于感染的鉴别诊断。
Introduction: At the end of March, 2020, rapid tests detecting the presence of antiviral IgM and IgG antibodies against SARS-CoV-2 virus were introduced in Hungary for the identification of SARS-CoV-2 infection (COVID-19 disease).Aim: We evaluated two rapid tests (Anhui and Clungene) in comparison with those of real-time PCR tests considered as the gold standard in the detection of infection.Method: Between 16, March and 14, April, 2020, we performed rapid IgM and IgG detecting tests without PCR; PCR without rapid tests; and PCR WITH rapid tests in 4140, 3210 and 1654 patients, respectively. (Out of these 1654 patients, Anhui and Clungene tests were used for testing in 625 and 1029 patients, respectively.) Patients were considered as positive in PCR and rapid tests when PCR positivity and IgM or IgG positivity occurred at any time, respectively. (Note: Clungene test is also marketed as 'Lungene'.)Results: The prevalence of PCR positivity in 4864 patients tested with PCR was 6.3%. The sensitivity and specificity of Anhui and Clungene tests were 33.3% and 72.85%, and 35.48% and 85.02%, respectively. At 6% PCR positivity, the positive and negative predictive values of Anhui and Clungene were 7.28%, 94.48%, 13.13%, and 95.38%, respectively.Conclusion: The low positive predictive values indicate that Anhui and Clungene rapid tests detecting the presence of anti-IgM and anti-IgG against SARS-CoV-2 virus infection are not suitable for screening SARS-CoV-2 virus infection in the general population. These results strongly support that Anhui and Clungene rapid tests detecting IgM and IgG antibodies against SARS-CoV-2 virus should not be used in the differential diagnosis of infection.