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[两种胎膜早破检测方法(胰岛素样生长因子结合蛋白-1/胎盘碱性磷酸酶-1)在临床实践中的诊断性能比较]

[Comparison of diagnostic performance of two tests of premature rupture of membranes (IGFBP-1/PAMG-1) in clinical practice].

作者信息

Lecerf M, Vardon D, Morello R, Lamendour N, Dreyfus M

机构信息

Service de gynécologie-obstétrique, hôpital Femme-Enfant-Hématologie, avenue de la Côte-de-Nacre, 14033 Caen, France.

Service de gynécologie-obstétrique, hôpital Femme-Enfant-Hématologie, avenue de la Côte-de-Nacre, 14033 Caen, France.

出版信息

J Gynecol Obstet Biol Reprod (Paris). 2015 Nov;44(9):832-9. doi: 10.1016/j.jgyn.2014.10.012. Epub 2015 Jan 28.

Abstract

OBJECTIVES

Evaluate the two main immunochromatographic tests of premature rupture of membranes (PROM): Actimprom(®) based on the discovery of insulin-like growth factor binding protein-1 (IGFBP-1) and Amnisure(®) based on the discovery of placental alpha 1-microglobulin (PAMG -1). The comparison was made voluntarily in clinical practice and is interested in a population whose failure is not clean break.

MATERIALS AND METHODS

Prospective and comparative study performed on 2012, at the university hospital of Caen, in 85 patients with PROM suspected between 24 SA and 36 SA. The presence of blood, semen or vaginal infection has been notified. Frank rupture of membranes was an exclusion criterion.

RESULTS

Actimprom(®) and Amnisure(®) were detected PROM with a specificity, sensitivity, PPV and NPV respectively 89.4% (CI 79.4-95.6%), 68.4% (CI 43.5-87.4%), 65% (CI 40.8-84.6%) and 90.8% (CI 81-96.5%). The results of both tests were not influenced by the presence of blood or inflammatory disease.

CONCLUSION

Performance of these tests is probably related to the quality of the sample and the extraction step in bed of the patient. This work showed no significant difference between the two tests in terms of performance in the diagnosis of PROM. At present, there is no formally favor the use of one or the other.

摘要

目的

评估胎膜早破(PROM)的两种主要免疫层析检测方法:基于胰岛素样生长因子结合蛋白-1(IGFBP-1)检测的Actimprom(®)和基于胎盘α1-微球蛋白(PAMG-1)检测的Amnisure(®)。该比较是在临床实践中自愿进行的,研究对象为胎膜早破诊断不明确的人群。

材料与方法

2012年在卡昂大学医院对85例妊娠24周龄至36周龄疑似胎膜早破的患者进行了前瞻性比较研究。已告知存在血液、精液或阴道感染情况。胎膜完全破裂为排除标准。

结果

Actimprom(®)和Amnisure(®)检测胎膜早破的特异性、敏感性、阳性预测值和阴性预测值分别为89.4%(95%CI:79.4 - 95.6%)、68.4%(95%CI:43.5 - 87.4%)、65%(95%CI:40.8 - 84.6%)和90.8%(95%CI:81 - 96.5%)。两种检测结果均不受血液或炎症性疾病存在与否的影响。

结论

这些检测的性能可能与样本质量及患者床上采集步骤有关。这项研究表明,在胎膜早破诊断性能方面,两种检测方法无显著差异。目前,没有正式的证据支持优先使用其中一种检测方法。

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