临床检验医学网-幸福检验

【摘要】  目的： 评价两种国产CA199化学发光试剂盒的检测结果。方法： 对54例高、中、低值的CA199阳性以及30例CA199阴性的血清用两种国产发光试剂盒以及Beckman发光试剂盒进行CA199检测，从准确性、精密度、阳性率以及预期值等方面与Beckman试剂进行比对。结果： 国产A和B试剂盒的CA199结果在准确性和精密度上与Beckman结果有一定差异。国产A试剂盒的CA199阳性率、阳性预期值和阴性预期值与Beckman结果无明显差异(P>0.05)。当以说明书上参考范围为阳性判断标准时，国产B试剂盒CA199阳性率和阳性预期值与Beckman结果有明显差异(P<0.01)。但是当以>24 U/ml为阳性判断标准时，国产B试剂盒CA199阳性率、阳性预期值和阴性预期值均为100%。国产A试剂盒和国产B试剂盒的CA199结果与Beckman的结果有明显的相关性(r=0.94，P<0.01;r=0.89，P<0.01)。结论： 国产试剂的CA199结果与Beckman结果存在明显相关性，在阳性率、诊断效率上可以与进口试剂相媲美，符合临床要求，可以替代进口产品。

【关键词】  糖类抗原199; 化学发光; 国产产品; 进口产品; 评价

作者：安仙园    作者单位：(上海华东疗养院检验科，江苏 无锡 214065)

幸福检验网www.xf366.com感谢作者对论文的分享！

　Evaluation of domestic CA199 chemiluminescence assay kits

　　AN Xianyuan

　　(Department of Clinical Laboratory, Huadong Sanatorium, Wuxi Jiangsu 214065, China)

　　[Abstract] Objective: To evaluate the assay results of two domestic CA199 chemiluminescence assay kits. Methods: 54 CA199-positive sera with high, middle or low value and 30 CA199negative sera were separately detected by two domestic CA199 chemiluminescence assay kits and Beckman CA199 kit. The CA199 results of domestic kits were compared with Beckman kit from accuracy, precision, positive rate and predictive value. Results: The CA199 results of accuracy and precision of domestic kit A and B had a certain degree of difference with those of Beckman, respectively. The positive rate, the positive predictive value and the negative predictive value of domestic kit A CA199 kit had no difference with that of Beckman(P>0.05). Using the reference value in manual as the criterion, the CA199 positive rate and the positive predictive value of domestic kit B were obviously lower than that of Beckman(P<0.01). But using above 24U/ml as the criterion, the positive rate, CA199 positive and negative predictive value of domestic kit B were all 100%. The CA199 results of domestic kit A and B were conspicuous correlation with that of Beckman, respectively(r=0.94，P<0.01;r=0.89，P<0.01). Conclusion: There are manifest correlations between the CA199 results of domestic assay kits and that of Beckman, which can comparable with the imported CA199 assay kits in positive rate and diagnostic and meet the clinical requirement and can substitute imported products.

　　[Key words] carbohydrate antigen 199; chemiluminescence; domestic product; imported product;

　　evaluation

　　糖类抗原199(carbohydrate antigen 199，CA199)是诊断胃肠道肿瘤特别是胰腺和胆道肿瘤的一个很好的标志[1-2]。CA199的检测方法有很多种，其中化学发光分析方法越来越受到临床的重视和欢迎。目前CA199的化学发光检测试剂大多需要进口，成本较高。然而这种状态正在被打破，CA199检测试剂的国产化速度正在加快。本文对目前市场上应用较多的两种国产CA199试剂的检测结果进行比较，并与进口Beckman结果比对，以期了解国产CA199试剂的性能。

　　1 材料与方法

　　1.1 血清标本

　　收集我院体检人员中已用Beckman化学发光CA199试剂测定后的血清标本，共84例，-86℃保存。其中Beckman检测结果阳性(>37 U/ml)的标本54例，阴性的标本30例。阳性标本结果的具体分布范围：37～74 U/ml，20例;75～111 U/ml，20例;>111 U/ml，14例。