摘要：
目的：对采用酶联免疫捕获法的符克TM系统用于检测常见吸入物过敏原特异性IgE抗体（ sIgE）进行性能评价。方法参考CLSI EP方案，对符克TM系统进行性能评价。用符克TM系统检测户尘螨、粉尘螨、猫毛屑、狗毛屑、链格孢、艾蒿花粉6种常见吸入物过敏原sIgE，评估其精密度、灵敏度、线性范围等，并与ImmunoCAP®系统进行比对，比对样本来源于2016年5月25日至6月30日门诊患者血清792份，对定量结果进行线性回归分析，对定性结果进行Kappa一致性分析。结果符克TM系统检测户尘螨、粉尘螨、猫毛屑、狗毛屑、链格孢、艾蒿花粉sIgE的批内CV％为3．60％～6．53％，总CV％为3．57％～7．46％，均小于试剂盒标示不精密度。定量测定下限均小于0．35 KU／L，低于厂商标示灵敏度。户尘螨sIgE的线性范围0．37～94．30 KU／L（R2＝0．999，P＜0．001），链格孢sIgE的线性范围0．35～89．80 KU／L（R2＝0．998，P＜0．001），线性相关均良好。符克TM系统与ImmunoCAP®系统比较，定量结果有明显的直线相关性，户尘螨、粉尘螨、猫毛屑、狗毛屑、链格孢、艾蒿花粉的R2分别为0．356、0．473、0．847、0．478、0．254和0．355，P值均＜0．001；定性结果的阴性符合率、阳性符合率、总体符合率分别为99．2％（944／952），82．1％（528／643），92．3％（1472／1595），有高度一致性（Kappa＝0．835，P＜0．001）；分级一致率91．5％（1459／1595）。结论符克TM系统是国产自动化全定量过敏原sIgE检测系统，具有较高的精密度和灵敏度，与ImmunoCAP®系统比较相关性良好，可满足临床检测要求，具有实用价值，为临床应用提供了新的选择。（中华检验医学杂志，2016，39：824－828）%Objective To evaluate the performance of common inhalant allergen specific IgE antibodies (sIgE) measurement using capture enzyme-linked immunosorbent assay (ELISA), FookeTM system.Methods The performance of Fooke TM system was evaluated according to the CLSI EP documents . Specific IgE to 6 common inhalant allergens , Dermatophagoides pteronyssinus ( d1 ) , Dermatophagoides farina (d2), cat epithelium and dander (e1), dog epithelium and dander (e5), Alternaria Alternata (m6) and mugwort pollen ( w6), were measured by Fooke TM system.The precision, sensitivity, and linearity range were assessed.The results were compared with ImmunoCAP®system, collecting the compared samples from clinical patient serum from 25 May 2016 to 30 June 2016.Results The within run CVs of the 6 allergens were 3.60% -6.53%, and total CVs were 3.57% -7.46%, lower than the stated.Limit of quantitative determination was <0.35 KU/L, lower than the sensitivity stated.The linearity range of d1 and m6 was 0.37 -94.30 KU/L ( R2 =0.999, P<0.001 ) and 0.35 -89.80 KU/L ( R2 =0.998, P<0.001), which demonstrated a sound linear correlation .In the method comparison tests, the quantitative results between Fooke TM and ImmunoCAP®system had obvious linear correlation , R2 of d1, d2, e1, e5, m6 and w6 was 0.356, 0.473, 0.847, 0.478, 0.254 and 0.355, respectively, P <0.001.The negative, positive and overall agreement ratio of qualitative results was 99.2% ( 944/952 ) , 82.1% ( 528/643 ) and 92.3%(1 472/1 595), with high level of agreement (Kappa=0.835, P<0.001).The ranked agreement ratio was 91.5% (1 459/1 595) .Conclusions FookeTM system (Capture ELISA) is domestically produced, automated and quantitative allergen sIgE detecting system , which showed high precision and sensitivity, and sound correlation with ImmunoCAP® system, meeting the testing requirement .FookeTM system has practical value , which is a new option for clinical application .
