使用酶联免疫捕获法检测抗过敏原IgE——不同方法间和实验室间的质量评估  

Measurement of immunoglobulin E antibodies using liquid allergens-an inter-method and inter - laboratory quality assessmen

作　　者：沃纳·埃伯 博格·克拉 

机构地区：[1]克格拉茨大学,格拉茨奥地利

出　　处：《检验医学》2006年第B10期11-18,共8页Laboratory Medicine

摘　　要：目的采用较公认的固相免疫方法检测的Pharmacia CAP系统和使用液相酶联免疫吸附试验（ELISA）的Adaltis ALLERgen系统，针对检测质量和可操作性方面进行比较。方法在2个相互独立的实验室中，在批内和批间随机进行抗过敏原IgE抗体的精密度检测。所有的样本和质控品均严格按照操作规程进行操作，同时用2种方法对总IgE抗体和特异性IgE抗体进行平行测试。另外，其中一个实验室还参加奥地利全国室间实验室过敏原系统质量评估。结果2个系统在灵敏度和特异性上有可比性并表现出较好的相关性。总IgE和特异性IgE在批内和批间的精密度评估都令人满意。对于各种不同过敏原，变异系数值在可接受的范围内。使用外部质量评估系统，从ALLERgen系统获得的数据和其他系统的数据有一致性。从与临床的的吻合度方面，94％以上的结果与临床能较好的吻合。操作者对2种系统的可操作性都很满意。尤其是ALLERgen系统使用了全自动化操作，从而减少了操作工作量和工作时间，减少了操作误差对结果的影响。结论Pharmacia CAP系统和Adaltis ALLERgen系统都属于新一代易操作的过敏原检测系统。2种检测方法重复性好，结果偏离度较小。因此，对于评估血清中的特异性IgE和总IgE来说，ALLERgen系统是一个可靠的诊断系统。其检测的结果与CAP系统的检测结果相符合。Objective Two allergy systems, the well established Pharmacia CAP system that uses the allergens conventionally in a solid phase and the ALLERgen system that employs liquid allergens, were compared with regard to quality criteria as practicability. Methods Defined serum pools were checked for within-run and between-days impression of immunoglobulin E （IgE） antibody men from allergic patient＇s and controls were tested in.parallel using both methods for total and antigen-specific IgE antibody detection under standardized conditions. In addition, one laboratory working exclusively with the ALLERgen system participated in the Austrian inter-laboratory quality assessment program. Results The two systems were comparable in terms of sensitivity and specificity, and also showed good correlation. Within-run evaluations were excellent for total IgE and antigen-specific IgE, and the between-clays impression was satisfactory. Coefficients of variation were within an acceptable range for the different groups of allergens. In the external quality control program the data obtained with the ALLERgen system showed good concordance with other systems in use up to 94% of the results were identical when considering clinically relevant sensitization for the operator, the ALLERgen system offered a certain advantage in terms of automated operation, which resulted in shorter fixed and variable phases of personnel time. Conclusions Both Pharmacia CAP system and the ALLERgen system belong to an advanced generation of allergy test systems and are easy to handle. The reproducibility of results is good with both metods, and the impression data fall within an acceptable range. Thus, the ALLERgen system is a reliable in vitro system for evaluating specific and total IgE in serum, providing data equivalent to those obtained with the CAP system.

关 键 词：IGE 放射过敏原吸附试验 ALLERgen系统 CAP系统 多参数评估 

分 类 号：R446.62[医药卫生—诊断学]