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目的探讨实时荧光定量PCR与EV 71-IgM抗体捕获ELISA两种方法检测肠道病毒71型的差异及一致性及临床意义。方法釆集1539例手足口病患儿咽拭子及血清,分别采用实时荧光定量PCR与ELISA法检测肠道病毒71型的RNA及IgM抗体。结果实时荧光定量PCR的EV71及EV 71-IgM抗体捕获ELISA的阳性率分别为63.5%和61.9%,两者全阳性占56.9%,两者全阴性占31.4%;两种方法的阳性率无明显差异P=0.073,两种方法结果总符合率为88.4%,一致性检验Kappa=0.751,说明两方法吻合程度较高。结论 ELISA法检测EV71-IgM抗体作为一种新的检测方法与实时荧光定量PCR具有较高的一致性,可在各级检验机构中广泛应用。但ELISA法有一定的局限性,在病情早期阶段或免疫功能低下时,有些病例漏诊,最好联合进行病毒RNA检测或过一定时间复查。
Objective To investigate the difference and consistency of real-time fluorescence quantitative PCR and EV 71-IgM antibody capture ELISA in detection of enterovirus 71 and its clinical significance. Methods Throat swab and serum from 1539 hand, foot and mouth disease patients were collected. The RNA and IgM antibodies of enterovirus 71 were detected by real-time fluorescence quantitative PCR and ELISA respectively. Results The positive rates of EV71 and EV 71-IgM antibody capture ELISA for real-time PCR were 63.5% and 61.9%, respectively. The positive rates of both were 56.9% and 31.4%, respectively. There was no significant difference between the two methods The difference P = 0.073, the total coincidence rate of the two methods was 88.4%, the consistency test Kappa = 0.751, indicating a high degree of agreement between the two methods. Conclusion ELISA assay of EV71-IgM antibody as a new detection method with real-time fluorescence quantitative PCR has a high consistency, can be widely used in testing agencies at all levels. However, the ELISA method has some limitations. In the early stage of disease or immunocompromised patients, some cases are misdiagnosed, and the best combination of viral RNA test or over time review.