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目的:为确认新型过敏原特异性Ig E抗体检测试剂盒(芯片法)的可信度,将芯片法与荧光酶联免疫法进行对比分析。方法:芯片法运用荧光免疫吸附分析的原理,针对6种过敏原的特异性Ig E进行检测,并对比与荧光酶联免疫法检测结果的阳性一致率、阴性一致率、整体一致率,探讨kappa值。共有456例样本用于对比分析。结果:芯片法所检测的阳性率分别为屋尘螨88.6%、猫毛皮屑92.9%、鸡蛋白92.5%、虾91.5%、蚌99.3%、蟹92.2%;而荧光酶联免疫法的阳性率分别为屋尘螨88.6%、猫毛皮屑92.9%、鸡蛋白92.5%、虾85.2%、蚌93.1%、蟹92.2%。6种过敏原的kappa值分别为屋尘螨1.000、猫皮屑1.000、鸡蛋白1.000、虾0.695、蚌0.172与蟹1.000。对于4种常见过敏原屋尘螨、猫皮屑、鸡蛋白与蟹,芯片法与荧光酶联免疫法的测定结果完全一致。虾与蚌的检测一致性偏低,可能因为阴性样本数偏低、检测值位于阈值附近及芯片法敏感度较高所导致。结论:芯片法与荧光酶联免疫法检测变应原特异性Ig E具有高度一致性,芯片法的检测结果敏感性高,是临床上过敏原特异性Ig E检测的可靠工具。
OBJECTIVE: To confirm the reliability of the new allergen-specific Ig E antibody test kit (chip method), the chip method and fluorescent enzyme-linked immunosorbent assay were compared. Methods: The chip method using the principle of fluorescence immunoassay analysis for the six allergens specific Ig E were detected and compared with the results of fluorescent enzyme-linked immunosorbent assay positive consistency rate, negative agreement rate, the overall agreement rate, to explore kappa value. A total of 456 samples were used for comparative analysis. Results: The positive rates detected by the chip method were 88.6% for house dust mite, 92.9% for cat fur dander, 92.5% for egg white, 91.5% for shrimp, 99.3% for mussels and 92.2% for crabs. The positive rates of fluorescent enzyme-linked immunosorbent assay House dust mites 88.6%, cat fur dander 92.9%, egg white 92.5%, shrimp 85.2%, mussel 93.1%, crab 92.2%. The kappa values of the six allergens were 1.000 house dust mite, cat litter 1.000, egg white 1.000, shrimp 0.695, clams 0.172 and crab 1.000, respectively. For the four common allergens house dust mites, cat dander, egg white and crab, chip and fluorescence enzyme-linked immunosorbent assay results are exactly the same. The consistency of the detection of shrimp and mussels is low, probably due to the low number of negative samples, the detection value near the threshold and the high sensitivity of the chip method. Conclusion: The chip method and fluorescent enzyme-linked immunosorbent assay for the detection of allergen-specific IgE are highly consistent and the chip-based assay is highly sensitive and is a reliable tool for clinical allergen-specific IgE testing.