摘要
目的比较荧光RT-PCR法与胶体金免疫层析法(GICA)在手足口病(HFMD)患儿病原学快速诊断中的应用价值,为实验室诊断提供参考。方法选取HFMD患儿454例(其中重症患儿190例,普通患儿264例)以及非肠道病毒感染、健康体检儿童共117例。同时采集患儿急性期咽拭子和血清标本各1份,分别进行肠道病毒EV通用型、EV71型和CA16型病毒核酸以及血清EV71-IgM、CA16-IgM抗体检测。比较两种方法对EV71、CA16的检测结果;并以RT-PCR法为金标准,对GICA法检测的诊断性能进行评价。结果荧光RT-PCR法检测重症HFMD组EV71阳性率72.6%(138/190),CA16阳性率10.0%(19/190);普通HFMD组EV71阳性率28.0%(74/264),CA16阳性率30.3%(80/264),两组HFMD肠道病毒感染分布构成比差异有统计学意义(χ~2=88.66,P=0.00)。454例HFMD患儿中,RT-PCR法与GICA法检测EV71型,阳性率分别为46.7%和58.6%,差异有统计学意义(χ~2=39.01,P=0.00);RT-PCR法与GICA法检测CA16型,阳性率分别为21.8%和30.0%,差异有统计学意义(χ~2=22.74,P=0.00)。以RT-PCR法法为金标准,GICA法诊断EV71的灵敏度95.7%,特异度84.4%,阳性预测值76.3%,阴性预测值95.2%,准确度84.1%;诊断CA16的灵敏度89.9%,特异度86.7%,阳性预测值65.4%,阴性预测值96.8%,准确度87.4%。结论 GICA法是一种简便、灵敏的检测方法,可用于HFMD病原体的快速筛查,与RT-PCR法具有较好的互补性;两种方法联合检测对HFMD的早期诊断与防控具有十分重要的意义。
Objective To compare the application of colloidal gold immunochromatography assay （GICA） to fluorescence RT-PCR in rapid pathogenic diagnosis of hand,foot and mouth disease （HFMD）.Methods Four hundred and fifty four children with HFMD diagnosed in our hospital from March to November 2016 were enrolled,including 190 severe cases and 264 mild case;and 117 healthy children served as controls.The throat swabs and serum samples were collected.The nucleic acids of enterovirus,enterovirus type 71 （EV71）,Coxsackievirus A16 （CA16） were determined by RT-PCR and G ICA,the serum antibody tests for EV71-IgM and CA16-IgM were also performed.The test results of EV71 and CA16 by using two methods were compared;and RT-PCR was taken as gold standard to evaluate the diagnostic capacity of GICA.Results The positive rates of EV71 and CA16 by RT-PCR method in severe patients were 72.6%（138/190） and 10.0% （19/190）,in mild patients were 28% （74/264） and 30.3%（80/264）,respectively （x2=88.66,P=0.01）.The positive rates of EV71 in all 454 cases by RT-PCR and GICA were 46.7% and 58.6%,respectively （x2=39.01,P=-0.01）,the positive rates of CA16 by RT-PCR and GICA were 21.8% and 30.0%,respectively （x2=22.74,P=0.01）.With RT-PCR results as gold standard,the sensitivity,specificity,positive predictive value,negative predictive value and the accuracy of GICA in detection of EV71 were 95.7%,84.4%,76.3%,95.2% and 84.1%,those for CA16 were 89.9%,86.7% 65.4%,96.8% and 87.4%,respectively.Conclusion GICA is a simple,sensitive method in rapid screening pathogens of hand,foot and mouth disease,which can be used as a complementary method to RT-PCR.
出处
《浙江医学》
CAS
2017年第14期1179-1182,共4页
Zhejiang Medical Journal
基金
浙江省科技厅公益技术应用研究计划项目(2015C33279)
嘉兴市科技计划项目(2013AY21042-7)
关键词
手足口病
肠道病毒属
核酸
抗体
诊断
Hand, foot and mouth disease Enterovirus Nucleic acid Antibody Diagnosis
