基于金标免疫层析技术SARS-CoV-2抗体检测COVID-19的临床应用价值分析

Clinical evaluation of a rapid antibody test based on lateral flow assay for SARS-CoV-2 infection diagnosis in COVID-19

目的研究基于金标免疫层析技术新型冠状病毒(SARS-CoV-2)抗体检测对新型冠状病毒肺炎(COVID-19)的临床应用价值。方法大肠杆菌表达SARS-CoV-2 N蛋白,应用重组N蛋白制备双抗原夹心SARS-CoV-2抗体金标检测试剂盒,用该试剂盒检测95例COVID-19确诊患者,41例疑似患者,88例排除COVID-19的发热和肺部感染患者及48例发热门诊工作医务人员血清样本,SARS-CoV-2核酸检测(RT-PCR)作为金标准对照,以特异性、灵敏度、阳性预测值、阴性预测值及准确度评价其临床应用价值。对比分析不同感染时期COVID-19确诊和疑似患者及境外输入性与本地COVID-19确诊和疑似患者SARS-CoV-2抗体检测结果。分析SARS-CoV-2抗体检测试剂交叉反应及基础性疾病干扰实验。采用SPSS 23.0软件进行统计分析,以P<0.05表示差异有统计学意义。结果SARS-CoV-2特异性抗体检测试剂的特异性、灵敏度、阳性预测值、阴性预测值及准确度分别为96.32%、81.05%、93.90%、87.91%、90.04%。COVID-19疑似患者的血清抗体阳性率与COVID-19确诊患者之间差异有统计学意义(P=0.002),与非COVID-19患者之间差异有统计学意义(P<0.001)。COVID-19确诊和疑似患者入院首次血清抗体阳性率与其住院期间的检测结果差异无统计学意义(P>0.05)。境外输入性COVID-19确诊和疑似患者抗体阳性率与本地患者之间差异均无统计学意义(P>0.05)。SARS-CoV-2抗体检测试剂与肺炎支原体和其他呼吸道病原体感染之间交叉反应较低,基础性疾病的干扰也较低。结论基于免疫层析的SARS-CoV-2抗体检测对COVID-19诊断特异性强,灵敏度和准确度高,与病毒核酸检测联合应用可用于COVID-19早期诊断和疑似患者的排除。

Objective To study the clinical application value of a rapid antibody test based on lateral flow assay for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection diagnosis in Corona Virus Disease 2019(COVID-19).Methods The SARS-CoV-2 N protein was expressed in Escherichia coli,and a rapid antibody test based on lateral flow assay for SARS-CoV-2 infection diagnosis was developed.The serums of 95 cases of patients with COVID-19,41 cases with suspected COVID-19,88 cases with general fever or pulmonary infection,48 doctors and nurses who worked in fever clinics were tested by the rapid SARSCoV-2 antibody test,and the throat swab from all patients,doctors and nurses were tested by RT-PCR kit of SARS-CoV-2.The SARS-CoV-2 antibody positive rate of the patients with COVID-19 and patients with suspected COVID-19 was compared between the 1st serum after being hospitalized and the serum during treatment.The SARS-CoV-2 antibody positive rate of the patients with COVID-19 and patients with suspected COVID-19 was compared between this locality and overseas imported cases.The cross reaction and disturbing influence was analyzed.Results The testing results of SARS-CoV-2 antibody showed that its specificity was 96.32%,sensitivity 81.05%,positive value 93.90%,negative value 87.91%and accuracy 90.04%.The SARS-CoV-2 antibody positive rate had significant difference between patients with COVID-19 and patients without COVID-19(P<0.001),and also significant difference between patients with suspected COVID-19 and those without COVID-19(P<0.001).The SARS-CoV-2 antibody positive rate showed no significant difference between the 1st serum after being hospitalized and the serum during treatment(P>0.05),and no significant difference between this locality and overseas imported cases in COVID-19 and non COVID-19(P>0.05).The SARS-CoV-2 antibody test kit had low cross reaction with other respiratory system pathogenic microorganisms,and the fundamental disease had a low disturbing influence on SARS-CoV-2 antibody testing.Conclusion The SARS-CoV-2 antibody test based on lateral flow assay in COVID-19 has a high specificity and sensitivity,and can be used for SARS-CoV-2 infection diagnosis combined with RT-PCR.