Vásárhelyi Barna, Kristóf Katalin, Ostorházi Eszter, Szabó Dóra, Prohászka Zoltán, Merkely Béla
Általános Orvostudományi Kar, Laboratóriumi Medicina Intézet,Semmelweis Egyetem Budapest, Nagyvárad tér 4., 1089.
Általános Orvostudományi Kar, Orvosi Mikrobiológiai Intézet,Semmelweis Egyetem Budapest.
Orv Hetil. 2020 May 1;161(20):807-812. doi: 10.1556/650.2020.31859.
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 vírus 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. Orv Hetil. 2020; 161(20): 807-812.
2020年3月底，匈牙利引入了用于检测抗SARS-CoV-2病毒的抗病毒IgM和IgG抗体的快速检测方法，以识别SARS-CoV-2感染（COVID-19疾病）。目的：我们评估了两种快速检测方法（安徽和隆基因），并与被视为检测感染金标准的实时PCR检测方法进行比较。方法：在2020年3月16日至4月14日期间，我们分别对4140例、3210例和1654例患者进行了不进行PCR的快速IgM和IgG检测、不进行快速检测的PCR检测以及进行快速检测的PCR检测。（在这1654例患者中，分别使用安徽和隆基因检测对625例和1029例患者进行检测。）当PCR呈阳性以及IgM或IgG呈阳性时，患者在PCR和快速检测中分别被视为阳性。（注意：隆基因检测也以“Lungene”销售。）结果：在接受PCR检测的4864例患者中，PCR阳性率为6.3%。安徽和隆基因检测的敏感性和特异性分别为33.3%和72.85%，以及35.48%和85.02%。在PCR阳性率为6%时，安徽和隆基因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：低阳性预测值表明，检测抗SARS-CoV-2病毒感染的抗IgM和抗IgG的安徽和隆基因快速检测方法不适用于普通人群中SARS-CoV-2病毒感染的筛查。这些结果有力地支持了安徽和隆基因检测抗SARS-CoV-2病毒IgM和IgG抗体的快速检测方法不应用于感染的鉴别诊断。《匈牙利医学周报》。2020年；161(20):807 - 812。
