新型冠状病毒肺炎患者抗体动态变化及其与疾病严重程度相关性研究

Kinetics of SARS-CoV-2 antibodies in COVID-19 patients and relationship with severity of disease

目的基于国内已上市的四家胶体金法新型冠状病毒(severe acute respiratory syndrome coronavirus 2,SARS-COV-2)抗体检测试剂,分析患者抗体动态变化及其与疾病严重程度的关系,了解患者免疫应答情况及胶体金试剂的临床诊断效能。方法应用国内已上市的四家胶体金法抗体检测试剂盒检测2020年1月21日—4月11日在广州医科大学附属市八医院住院的60例(其中48例轻症,12例重症)新冠肺炎患者的290份血浆标本,操作步骤按照试剂盒说明书严格进行,分析评判4种胶体金法抗体检测试剂的临床诊断性能。结果新型冠状病毒肺炎(新冠肺炎)患者抗体阳性率在发病早期有随病程延长而呈逐渐升高趋势,发病第1周内患者的阳性率为19.23%~34.62%,第2周和第3周内患者的抗体阳性率分别为52.27%~68.18%和83.05%~98.31%。IgM抗体阳性率在发病第4周达到峰值,之后第5~6周后表现出下降趋势,至第9周显著下降。但IgG抗体阳性率在两个月的观察期内没有显著降低;轻症和重症患者抗体阳性率差异无统计学意义,P>0.05;四家试剂对60例患者的诊断灵敏度为78.33%~91.67%;最高和最低值相比,差异有统计学意义,χ^(2)=4.183,P=0.041。结论胶体金法抗体试剂检测新冠肺炎患者的抗体阳性率早期较低,晚期升高;抗体阳性率与疾病严重程度没有相关性;不同的试剂检测灵敏度存在一定的差异。

Objective To study the kinetics of SARS-CoV-2 antibodies in COVID-19 patients and the correlation with disease severity.Methods A total of 290 plasma samples were collected from 60 hospitalized patients including 48 mild cases and 12 severe cases within 63 days after disease onset in Guangzhou Eighth People′s Hospital affiliated to Guangzhou Medical University during January 21 to April 11,2020.SARS-CoV-2 specific antibodies were determined by four commercial colloidal gold serologic reagents validated by National Medical Products Administration in China.Results The seropositive rate ranged from 19.23%to 34.62%by four assays within one week after disease onset,and rapidly increased within the following two weeks.The seropositive rates were 52.27%to 68.18%and 83.05%to 98.31%,respectively.IgM antibody peaked within the fourth week and maintained high level for 1 to 2 weeks,and decreased significantly until the 9 th week.But no obvious decreasing trend of the seropositive rate of IgG antibody was observed during two months after disease onset.The seropositive rates of antibodies between mild and severe cases showed no statistical difference.Four assays demonstrated a sensitivity of 78.33%to 91.67%in 60 COVID-19 patients.The difference was statistically significant between the highest and the lowest values(χ^(2)=4.183,P=0.041).Conclusions The colloidal gold serologic reagents show good sensitivity during the late stage of disease but not at the early stage.There is no correlation between seropositive and disease severity.The sensitivity of different reagents is different.