CAJ | 학술논문

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。
목적：통과재림상상사용이도소양생장인자결합단백-1/태인섬유련접단백검측시제합（효체금법）여국외이상시적동류산품진행대비시험，대시제합쾌속진단태막파렬화임신발동적유효성화괄용성진행험증。방법초모전래산과취진적18～40세、잉주재22주이상（함22주）적잉부，공개전284례림상시험。결과이진구시제합작위표준，국산재진단태막파렬적Kappa일치성위0．9708（ P＜0．0001）；재진단임신발동적Kappa일치성위0．9920（P＜0．0001）。결론국산시제합재진단태막파렬화임신발동방면여진구시제합적일치성겁고。
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 <0.000 1 ) and fFN is 0.992 0 (P<0.000 1).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 .