宫颈胰岛素样生长因子结合蛋白-1与胎儿纤维连接蛋白的联合检测的临床价值

The clinical value of joint detection of Insulin-like growth factor binding protein-1 and fetal fibronectin in cervical

目的：通过在临床上使用胰岛素样生长因子结合蛋白-1/胎儿纤维连接蛋白检测试剂盒（胶体金法）与国外已上市的同类产品进行对比试验，对试剂盒快速诊断胎膜破裂和妊娠发动的有效性和适用性进行验证。方法招募前来产科就诊的18～40岁、孕周在22周以上（含22周）的孕妇，共开展284例临床试验。结果以进口试剂盒作为标准，国产在诊断胎膜破裂的Kappa一致性为0．9708（P＜0．0001）；在诊断妊娠发动的Kappa一致性为0．9920（P＜0．0001）。结论国产试剂盒在诊断胎膜破裂和妊娠发动方面与进口试剂盒的一致性极高。

Objective To compare the effectiveness and applicability of domestic and imported Insulin-like Growth Factor Binding Protein-1 （IGFBP-1） and fetal fibronectin detection （fFN） kits, which were used for the rapidly diagnosingRupture of fetal membrane and Premature birth .Methods 284 pregnant women have been recruited, who were aged from 18 to 40, gestational weeks over 22 weeks （including 22 weeks）.Comparing and analyzing the specificity , sensitivity, positive predictive value and negative predictive value of different kits . Results The result proved thatKappa consistency check of IGFBP-1 is 0.970 8 （ P 〈0.0001 ） and fFN is 0.9920 （P〈0.0001）.Conclusions This study demonstrated that the domestic IGFBP-1 kit and fFN kit were in accordance with the import kits in diagnosingRupture of fetal membrane and premature birth .