新型冠状病毒IgM和IgG抗体4种不同检测试剂的临床应用评价

目的探讨4种不同的新型冠状病毒(2019-nCoV)特异性免疫球蛋白M(IgM)和免疫球蛋白G(IgG)抗体检测试剂盒在2019-nCoV感染临床诊断中的应用。方法招募164例新型冠状病毒肺炎(COVID-19)患者和132例同期初步排除2019-nCoV感染的疑似患者以及100名健康对照,收集临床资料和血清样本,采用3种全自动化学发光免疫分析法试剂盒(A、B和C1试剂盒,来自不同产家)和1种胶体金法试剂盒(C2试剂盒,和C1来自同一产家)进行2019-nCoV特异性IgM和IgG抗体的检测。结果A和C1试剂盒相比,对确诊病例血清IgM抗体阳性检出率分别是88.41%(61/69)和98.55%(68/69)(χ²=4.279,P<0.05)。对疑似病例血清IgM抗体阳性检出率分别是8.08%(8/99)和1.01%(1/99)(χ²=4.190,P<0.05),IgG抗体阳性检出率分别是10.10%(10/99)和1.01%(1/99)(χ²=6.160,P<0.05)。对健康对照血清IgM抗体阳性检出率分别是11.00%(11/100)和0(0/100)(χ²=9.620,P<0.05)。2种试剂盒IgM抗体检测结果有显著相关性(r=0.618,P<0.05),IgG抗体检测结果也有显著相关性(r=0.850,P<0.05)。C1和C2试剂盒相比,在确诊病例和健康对照血清中IgM和IgG抗体阳性检出率差异均没有统计学意义。A和B试剂盒相比,对确诊病例血清IgM抗体阳性检出率分别是82.00%(41/50)和54.00%(27/50)(χ²=9.007,P<0.05),2种试剂盒IgM抗体检测结果有显著相关性(r=0.654,P<0.05),IgG抗体检测结果也有显著相关性(r=0.770,P<0.05)。结论血清学特异性抗体检测时间短,生物安全性更高,可作为核酸检测的重要补充在临床上广泛应用。不同厂家的试剂盒检测效果存在一定程度上的差异,特别是针对不同靶抗原的试剂更是如此,但是都已经达到免疫学检测试剂的基本要求。

Clinical evaluation of four different detection reagents for 2019-nCoV IgM and IgG antibodies in patients with COVID-19 and suspected cases

Objective To evaluate the performances of four different antibody testing kits for 2019 novel coronavirus(2019-nCoV)and to explore their applications in clinical diagnosis of 2019-nCoV infections.Methods A total of 164 patients with corona virus disease 2019(COVID-19)who were admitted to Zhongnan Hospital of Wuhan University from January to February 2020 were included in this study.A total of 132 suspicious subjects with negative nucleic acid test of 2019-nCoV were also selected during the same period.A hundred healthy individuals were also included.Serum 2019-nCoV-specific immunoglobulin E(IgM)and IgG were analyzed using three chemiluminescence immune assays(A,B and C1 kits,from different manufacturers)and one colloidal gold-labeled assay(C2 kit,from the same manufacturer with C1).Results For the A and C1 kits,the positive rates of IgM of the confirmed individuals were 88.41%(61/69)and 98.55%(68/69)respectively(χ²=4.279,P<0.05).For the suspected cases,the positive rates of IgM were 8.08%(8/99)and 1.01%(1/99)(χ²=4.190,P<0.05),and the positive rates of IgG were 10.10%(10/99)and 1.01%(1/99)(χ²=6.160,P<0.05),respectively.As for the controls,the positive rates of IgM were 11.00%(11/100)and 0%(0/100)(χ²=9.620,P<0.05)respectively.There was a significant correlation between the IgM(r=0.618,P<0.05)and IgG(r=0.850,P<0.05)antibody results of the two kits.There were no significant differences in the positive rates of IgM and IgG between the confirmed cases and controls when C1 and C2 kits were used.For A and B kits,the positive rates of IgM for the confirmed individuals were 82.00%(41/50)and 54.00%(27/50)respectively(χ²=9.007,P<0.05).There was a significant correlation between the IgM(r=0.654,P<0.05)and IgG(r=0.770,P<0.05)antibody results of this two kits.Conclusions Serological 2019-nCoV-specific antibodies tests have the advantages of short detection time and high biological safety.They could be widely used as an important supplement to nucleic acid test in clinical practice.The detection effects of the different kits varies to some extent,especially for different target antigens,but all of them have met the basic requirements of immunological detection reagents.