论文部分内容阅读
目的:评估国产和进口的两种胎儿纤维连接蛋白(fetal fibronectin,fFN)检测试剂盒在早产快速诊断的一致性。方法:招募前来产科就诊的18~40岁、孕周在22~35周的孕妇245例,对其宫颈阴道分泌物分别予以两种fFN试剂盒检测。结果:以进口试剂盒作为标准,国产试剂盒的灵敏度为97.37%,特异度为96.45%,阳性预测值为92.50%,阴性预测值为98.79%,两者的Kappa一致性检验为Kappa=0.924(P<0.001)。结论:进口与国产的fFN检测试剂盒在诊断早产方面具有高度一致性;国产fFN检测试剂盒适用于临床上进行早产诊断。
OBJECTIVE: To assess the rapid diagnostic consistency of the two fetal fibronectin (fFN) test kits, both domestic and imported, in preterm labor. METHODS: 245 pregnant women, 18 to 40 years old and 22 to 35 weeks gestational age, were enrolled in obstetrics and gynecology. Two kinds of fFN kits were tested for cervical vaginal secretions respectively. Results: The sensitivity of the kit was 97.37%, the specificity was 96.45%, the positive predictive value was 92.50% and the negative predictive value was 98.79%. The Kappa consistency test between the two kit was Kappa = 0.924 P <0.001). Conclusion: The imported and domestic fFN detection kits are highly consistent in the diagnosis of preterm labor. The domestic fFN detection kits are suitable for the clinical diagnosis of premature labor.