流感病毒抗原快速检测试剂灵敏度及特异性评价  

Evaluation on sensitivity and specificity of the rapid test of influenza virus antigen

作　　者：吴亦琳 花盛浩[1] Wu Yiling;Hua Shenghao(Clinical Laboratory of Children's Hospital of Soochow University,Suzhou 215003,China)

机构地区：[1]苏州大学附属儿童医院检验科,215003

出　　处：《国际病毒学杂志》2024年第1期33-36,共4页International Journal of Virology

基　　金：苏州市科教兴卫青年科技项目(KJXW2021020)。

摘　　要：目的评价流感病毒抗原快速检测试剂在儿童应用中的灵敏度及特异性.方法选取2021年12月至2022年2月于苏州大学附属儿童医院就诊的361例流感样病例入组,采集双份鼻拭子,分别采用抗原快速法和荧光PCR法检测流感病毒,以荧光PCR法为金标方法,分析抗原快速法的灵敏度及特异性.结果抗原快速法和荧光PCR法的患儿总检出率、不同性别患儿检出率和不同年龄段患儿检出率均无统计学差异(P>0.05).但是,抗原快速法的灵敏度和特异性明显低于荧光PCR法,差异有统计学意义(P<0.05).另外,根据患儿不同年龄段分析其灵敏度和特异性,结果发现,在<3岁的婴幼儿中,抗原快速法的特异性较高,灵敏度较低,其阳性结果更有意义,而在>6岁的学龄儿童中,其灵敏度较高,特异性较低,其阴性结果更有意义.结论由于抗原快速法在不同年龄段患儿中灵敏度和特异性的差异,其在婴幼儿和学龄前儿童中的阳性结果更为可靠,阴性有漏检的可能,而在学龄儿童中的阴性结果更为可靠,阳性有误诊的可能,有助于临床医生结合患儿年龄解读抗原快速法的检测结果.Objective To evaluate the sensitivity and specificity of a rapid test reagent of influenza virus antigen in the application for children.Methods Double nasopharyngeal swabs were collected from 361 patients with flu-like symptoms in Children's Hospital of SooChow University from December 2021 to February 2022.The rapid test of influenza virus antigen and fluorescent PCR were used to detect influenza virus.The sensitivity and specificity of antigen test was evaluated using PCR as the reference method.Results There was no statistically significant difference in overall positive detection rates,positive detection rates among children of different genders and age groups between fluorescent PCR and the rapid test of influenza virus antigen(P>0.05).However,the sensitivity and specificity of the rapid test of influenza virus antigen was significantly lower than those of fluorescence PCR(P<0.05).In addition,for the sensitivity and specificity in different age groups,the rapid test had higher specificity and lower sensitivity during infants(<3 years)indicating the diagnostic value of the positive results.For children>6 years old,the rapid test had higher sensitivity and lower specificity,indicating the diagnostic value of the negative results.Conclusions Because of the differences in sensitivity and specificity of the rapid test of influenza virus antigen in different age groups of children,the positive results were reliable for infants and pre-school children with the possibility of missing case by false negative.For school students the negative results were reliable while positive results may lead to false diagnosis.This would assist clinicians to interpret the results of the rapid test of influenza virus antigen.

关 键 词：流感性感冒 抗原快速检测试剂 灵敏度 特异性 儿童 

分 类 号：R511.7[医药卫生—内科学] R44[医药卫生—临床医学]