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目的:比较研究国产与进口胰岛素样生长因子结合蛋白(insulin-like growth factor binding protein,IGFBP)-1检测试剂盒(胶体金法)快速诊断胎膜早破(premature rupture of fetal membrane,PROM)的性能。方法:取87例PROM患者为阳性组,153例胎膜未破孕妇为对照组,对其宫颈分泌物分别予以进口和国产的IGFBP-1试剂盒检测;并结合pH试纸的检测结果,比较两种IGFBP-1试剂盒的灵敏度、特异度、阳性预测值、阴性预测值。结果:国产与进口的IGFBP-1试剂盒诊断PROM的Kappa一致性检验为0.97(P<0.000 1)。结论:国产与进口的IGFBP-1检测试剂盒诊断PROM结果一致性较佳;与pH试纸比较,国产IGFBP-1检测试剂盒在检测PROM中具备显著的优越性。
OBJECTIVE: To comparatively study the rapid diagnosis of premature rupture of fetal membrane (PROM) by using the domestic and imported insulin-like growth factor binding protein (IGFBP) -1 test kit (colloidal gold method) performance. Methods: A total of 87 patients with PROM were selected as positive group and 153 pregnant women without fetal membranes as control group. The cervical secretions were respectively imported and domesticated with IGFBP-1 kit. Combined with the test results of pH test strips, The sensitivity, specificity, positive predictive value and negative predictive value of the IGFBP-1 kit. Results: The Kappa consistency test of diagnostic PROM by domestic and imported IGFBP-1 kit was 0.97 (P <0.000 1). CONCLUSION: The consistency between the domestic and imported IGFBP-1 test kit in diagnosis of PROM is better. Compared with pH test strips, the domestic IGFBP-1 test kit has significant advantages in detecting PROM.