基于胶乳增强免疫比浊法的食物过敏原检测试剂盒方法学的建立及临床应用评价
发布时间：2019-04-15 19:38
【摘要】：目的:建立基于胶乳增强免疫比浊法的食物过敏原检测试剂的方法并应用于临床。方法:采用胶乳增强免疫比浊法,对检测体系的标准曲线、最低检测量、稳定性、精密度、干扰实验等相关性能指标进行评价,通过检测健康体检人员及临床过敏人群血液标本并与目前应用于临床的较成熟的ELISA方法进行比对,评价胶乳增强免疫比浊法的食物过敏原检测试剂的临床应用可行性。结果:该方法的标准曲线Y=837.1x~2-125.2x+10.036,线性范围:0~400 U/ml,相关系数为0.996,最低检测限为19.600 U/ml。批内、批间精密度均10%。该方法的正常参考范围为33.5 U/ml,敏感度89.61%,特异性65.22%,准确度84.00%,阳性预示值89.61%,阴性预示值65.22%,ROC的曲线下面积(AUC)为0.957,该方法与目前应用较广泛的ELISA法具有很强的相关性(r=0.890 2)。结论:胶乳增强免疫比浊法的食物过敏原检测试剂符合临床诊断的相关要求,可应用于临床食物过敏性患者的诊断及疾病监测。
[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.
【作者单位】： 瑞安市中医院检验科;瑞安市人民医院检验科;
【基金】：瑞安市科技局项目(No.MS2015042)
【分类号】：R446.6
，
本文编号：2458434
[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.
【作者单位】： 瑞安市中医院检验科;瑞安市人民医院检验科;
【基金】：瑞安市科技局项目(No.MS2015042)
【分类号】：R446.6
，
本文编号：2458434
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