诊断学理论与实践

诊断学理论与实践 ›› 2019, Vol. 18 ›› Issue (04): 454-459.doi: 10.16150/j.1671-2870.2019.04.014

• 论著 • 上一篇    下一篇

三种不同品牌ELISA试剂盒检测ASCA的结果比较及性能评估

余悠悠, 曾俊祥, 罗婷, 邓琳, 潘秀军()   

  1. 上海交通大学医学院附属新华医院检验科,上海 200092
  • 收稿日期:2018-11-01 出版日期:2019-08-25 发布日期:2019-08-25
  • 通讯作者: 潘秀军 E-mail:Pan.xiujun@hotmail.com
  • 基金资助:
    上海市科学技术委员会科研计划项目(15DZ1940800);上海市卫生局课题(20154Y0095)

Comparison of results and evaluation of performance of three different ELISA kits for detection of ASCA

YU Youyou, ZENG Junxiang, LUO Ting, DENG Lin, PAN Xiujun()   

  1. Department of Clinical Laboratory, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
  • Received:2018-11-01 Online:2019-08-25 Published:2019-08-25
  • Contact: PAN Xiujun E-mail:Pan.xiujun@hotmail.com

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摘要：

目的： 比较3种品牌酶联免疫吸附试验（enzyme-linked immunosorbent assay, ELISA）试剂盒检测血清抗酿酒酵母菌抗体（anti-saccharomyces cerevisiae antibodies, ASCA）的结果,分析一致性情况,并评估各试剂盒的主要检测性能,为临床使用提供参考。方法： 收集本院确诊炎症性肠病（inflammatory bowel disease,IBD）患者140例,其中克罗恩病（Crohn’s disease,CD）87例和溃疡性结肠炎（ulcerativecolitis, UC）53例,疾病对照组（disease contorl,DC）40例。用3个品牌的ELISA试剂盒（试剂盒A为国产品牌、B和C为进口品牌）分别检测ASCA-IgA和ASCA-IgG,对结果进行比较分析。结果： CD组中3个品牌试剂盒ASCA-IgA和（或）ASCA-IgG的检出率均高于UC组及DC组（P<0.05）,而UC组与DC组间结果差异无统计学意义（P>0.05）。在UC组和DC组间,3种试剂的阳性检出率间差异无统计学意义（P>0.05）;在CD组中,试剂盒A与B的阳性检出率间差异无统计学意义（P>0.05）,而试剂盒C的结果低于试剂盒A、B,差异有统计学意义（P<0.05）。3种试剂检测结果的一致性分析显示,ASCA-IgA中,试剂盒A与B呈现中等一致性（Kappa：0.423）,试剂盒A与C、试剂盒B与C的一致性较差（Kappa分别为0.111和0.074）;ASCA-IgG中,试剂盒A与B、试剂盒B与C及试剂盒A与C均呈现中等一致性（Kappa分别为0.414、0.447和0.584）。评估3种ELISA试剂盒分别检测ASCA-IgA、ASCA-IgG及联合检测ASCA-IgA和ASCA-IgG诊断IBD的效能,试剂盒A灵敏度依次为37.90%、27.86%、43.57%,试剂盒B为20.71%、45.00%、51.43%,试剂盒C为9.29%、22.14%、25.71%;试剂盒A特异度依次为87.50%、85.00%、77.50%,试剂盒B为92.50%、90.00%、87.50%,试剂盒C为97.50%、90.00%、87.50%;试剂盒A约登指数分别为0.25、0.12、0.21,试剂盒B为0.13、0.35、0.38,试剂盒C为0.07、0.12、0.13;经受试者工作特征（receiver operating characteristic,ROC）曲线得出曲线下面积,试剂盒A分别为0.72、0.54、0.59,试剂盒B为0.54、0.72、0.69,试剂盒C为0.64、0.52、0.57。结论： 3种试剂盒在CD组均具有较高的ASCA检出率,说明ELISA检测ASCA对于CD的诊断和鉴别诊断具有一定应用价值。不同试剂间的检测结果一致性尚不理想,3种试剂ASCA-IgG检测结果一致性总体优于ASCA-IgA结果。3种试剂灵敏度均较低,不适合作为人群的IBD筛查指标,同时检测IgG和IgA抗体可提高检测灵敏度。检测性能试剂B>A>C,进口试剂不一定优于国产试剂,可根据实际情况合理选择试剂。

关键词: 克罗恩病, 结肠炎, 溃疡性, 血清抗酿酒酵母菌抗体, 酶联免疫吸附试验

Abstract:

Objective: To compare the results of three brands of ELISA (enzyme-linked immunosorbent assay） kits for detection of serum anti-Saccharomyces cerevisiae antibody ASCA)and to evaluate the performance of each kit for clinical reference. Methods: One hundred and forty patients with inflammatory bowel disease (IBD) were enrolled, including 53 patients with ulcerative colitis (UC), 87 patients with Crohn'sdisease (CD); and 40 other patients were served as disease control group (DC). Three ELISA kits (kid A is a domestic brand, B and C are imported brands) were used to detect ASCA-IgA and ASCA-IgG, and the results were analyzed and compared. Results: The detection rates of ASCA-IgA and/or ASCA-IgG in CD group were higher than those in UC group and DC group (P<0.05), but there was no significant difference between UC group and DC group (P>0.05). In UC group and DC group, the positive rates of three kits had no significant difference (P>0.05); in CD group, the positive rates of kit A and B had no significant difference (P>0.05), but the result of kit C was lower than that of kit A and B (P<0.05). The results of consistency analysis showed that kits A and B had moderate consistency in detecting ASCA-IgA (Kappa: 0.423), kits A and C, kits B and C showed poor consistency (Kappa: 0.111 and 0.074, respectively); kits A and B, kits B and C and kits A and C showed moderate consistency in detecting ASCA-IgG (Kappa: 0.414, 0.447 and 0.584, respectively). The analytical performance of detecting ASCA-IgA, ASCA-IgG by three ELISA kits separately and jointly for the diagnosis of IBD showed that the sensitivity was kit A (37.90%, 27.86%, 43.57%), kit B (20.71%, 45.00%, 51.43%), kit C (9.29%, 22.14%, 25.71%); specificity was kit A (87.5%, 85.00%, 77.50%), kit B (92.50%, 90.00%, 87.50%) and kit C (97.5%, 90.0%, 87.50%). The Youden index was kit A (0.25, 0.12, 0.21), kit B (0.13, 0.35, 0.38), kit C (0.07, 0.12, 0.13). The AUC area obtained by receiver operating characteristic (ROC) curve were kit A(0.72, 0.54, 0.59), kit B (0.54, 0.72, 0.69), kit C (0.64, 0.52, 0.57). Conclusions: All the three kits had high positive rate in CD group, It showed that ELISA detection of ASCA has certain application value for the diagnosis and differential diagnosis of CD. The consistency of test results of different kits was not satisfactory, the consistency of the results of ASCA-IgG was better than that of ASCA-IgA. All three kits have low sensitivity and are not suitable for IBD screening of the population. Detecting ASCA-IgG and ASCA-IgA antibodies simultaneously could improve the detection sensitivity. Test performance showes kit B > A >C. The imported kit is not necessarily superior to the domestic kit, and the brand of kit should be selected according to the actual situation.

Key words: Crohn’s disease, Ulcerative colitis, Anti-saccharomyces cerevisiae antibody, Enzyme-linked immunosorbent assay

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