国产CA199化学发光检测试剂盒的评价_临床医学论文.docVIP

国产CA19化学发光检测试剂盒的评价_临床医学论文 国产CA19化学发光检测试剂盒的评价_临床医学论文 【摘要】 目的： 评价两种国产CA19化学发光试剂盒的检测结果。方法： 对54例高、中、低值的CA19阳性以及30例CA19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阳性率、阳性预期值和阴性预期值与Beckman结果无明显差异(Pgt;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阳性率和阳性预期值与Beckman结果有明显差异(0.01)。但是当以gt;24 U/ml为阳性判断标准时，国产B试剂盒CA19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结果与Beckman的结果有明显的相关性(r=0.94，0.01;r=0.89，0.01)。结论： 国产试剂的CA19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化学发光; 国产产品; 进口产品; 评价 　　[Abstract] Objective: To evaluate the assay results of two domestic CA19were 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(Pgt;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(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=0.94，0.01;r=0.89，0.01). Conclusion: There are manifest correlations between the CA19 　　[Key words] carbohydrate antigen 19 　　evaluation 　　糖类抗原19，CA19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C