【摘要】：目的:建立基于膠乳增強(qiáng)免疫比濁法的食物過敏原檢測試劑的方法并應(yīng)用于臨床。方法:采用膠乳增強(qiáng)免疫比濁法,對檢測體系的標(biāo)準(zhǔn)曲線、最低檢測量、穩(wěn)定性、精密度、干擾實(shí)驗(yàn)等相關(guān)性能指標(biāo)進(jìn)行評價,通過檢測健康體檢人員及臨床過敏人群血液標(biāo)本并與目前應(yīng)用于臨床的較成熟的ELISA方法進(jìn)行比對,評價膠乳增強(qiáng)免疫比濁法的食物過敏原檢測試劑的臨床應(yīng)用可行性。結(jié)果:該方法的標(biāo)準(zhǔn)曲線Y=837.1x~2-125.2x+10.036,線性范圍:0~400 U/ml,相關(guān)系數(shù)為0.996,最低檢測限為19.600 U/ml。批內(nèi)、批間精密度均10%。該方法的正常參考范圍為33.5 U/ml,敏感度89.61%,特異性65.22%,準(zhǔn)確度84.00%,陽性預(yù)示值89.61%,陰性預(yù)示值65.22%,ROC的曲線下面積(AUC)為0.957,該方法與目前應(yīng)用較廣泛的ELISA法具有很強(qiáng)的相關(guān)性(r=0.890 2)。結(jié)論:膠乳增強(qiáng)免疫比濁法的食物過敏原檢測試劑符合臨床診斷的相關(guān)要求,可應(yīng)用于臨床食物過敏性患者的診斷及疾病監(jiān)測。
[Abstract]:Objective: to establish a method for the detection of food allergens based on latex enhanced immunoturbidimetry and its clinical application. Methods: latex enhanced immunoturbidimetry was used to evaluate the standard curve, minimum detection, stability, precision, interference test and other related performance indexes of the detection system. The feasibility of clinical application of latex-enhanced immunoturbidimetric assay for food allergen detection was evaluated by detecting blood samples of health check-up personnel and clinical allergic population and comparing them with the mature ELISA method used in clinic at present. Results: the standard curve of this method was Y=837.1x~2-125.2x 10.036, the linear range was 0 渭 400 U / ml, the correlation coefficient was 0.996, and the minimum detection limit was 19.600 U / ml. Within the batch, the inter-batch precision was 10%. The normal reference range of the method is 33.5 U / ml, the sensitivity is 89.61%, the specificity is 65.22%, the accuracy is 84.00%, the positive predictive value is 89.61%, the negative predictive value is 65.22%, and the area under the curve is (AUC) 0.957, This method has strong correlation with ELISA method, which is widely used at present (r = 0.8902). Conclusion: the method of latex enhanced immunoturbidimetry is suitable for the diagnosis of food allergens and can be used for the diagnosis and disease surveillance of the patients with food anaphylaxis.
【作者單位】： 瑞安市中醫(yī)院檢驗(yàn)科;瑞安市人民醫(yī)院檢驗(yàn)科;
【基金】：瑞安市科技局項(xiàng)目(No.MS2015042)
【分類號】：R446.6
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本文編號：2458434