胶体金免疫层析法对呼吸道合胞病毒抗原快速检测结果分析

Performance of colloidal gold immunochromatography assay in rapid detection of respiratory syncytial virus antigen

目的分析胶体金免疫层析法对呼吸道合胞病毒(RSV)抗原快速检测的灵敏度和特异度。方法用RSV抗原检测试剂盒(胶体金免疫层析法)对197例疑似RSV感染患者的鼻咽抽吸物或鼻咽拭子标本进行检测,以反转录聚合酶链反应(RT-PCR)核酸检测结果为参考,比较胶体金免疫层析法对不同类型标本和不同年龄组患者的灵敏度。结果 197例患者标本中经RT-PCR检测,95例(48.2%)为阳性。以RT-PCR核酸检测结果为标准,胶体金免疫层析法的灵敏度和特异度分别是34.7%和100%。该方法对鼻咽抽吸物的阳性检出率较鼻咽拭子高(36.2%对8.6%,P<0.01),鼻咽抽吸物标本的灵敏度明显高于鼻咽拭子(22.1%对12.6%)。RSV检出率与年龄呈负相关(P<0.01),1岁以下患儿的阳性检出率最高(29.5%),而在>5岁患儿中阳性检出率为0。结论胶体金免疫层析法对1岁以下幼儿的鼻咽抽吸物中的RSV有较好检测效果,可辅助临床进行早期筛查。但鉴于该方法灵敏度较低,且适用于5岁以下儿童,临床上还需用RT-PCR对RSV进行确认和补充检测,以免漏诊。

Objective To investigate the sensitivity and specificity of colloidal gold immunochromatography assay in rapid detection of respiratory syncytial virus （RSV） antigen. Methods A total of 197 nasal pharyngeal swabs （NPs） or nasal pharyngeal aspirates （ NPAs ） obtained from patients were tested by RSV assay kits, i. e. , colloidal gold imrnunochromatography assay. The results determined by reverse transcription polymerase chain reaction （RT PCR） were taken as reference. Compared to the results of RT-PCR, the sensitivity of the kit was different when testing different types of specimens or specimensobtained from patients of different ages. Results A total of 95 （48.2%） samples were positive for RSV tested by RT PCR. The sensitivity and specificity of colloidal gold immunochromatography assay were 34. 7% and 100%, respectively compared with RT PCR results. The positive rate of the assay was higher in testing NPAs than NPs （36.2% vs 8.6G, P〈0.01）, which was the same in the sensitivity （22. 1% vs 12. 6%）. The positive rate of colloidal gold immunochromatography assay showed negative correlation with the age of patients （P〈0.01）, which was highest in children less than one-year old （29.5%） but zero in patients more than five year old. Conclusions The colloidal gold immunochromatography assay is effective in early detection of RSV from NPAs in children less than one year old. It can be used in early diagnosis for children infected with RSV. Since colloidal gold immunochromatography assay has some limitations, and it is only suitable for the children under five-year old, RT PCR method should be used for RSV detection in clinical practice to avoid missed diagnosis.