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罗氏推出生育力检测试剂盒Elecsys AMH,评估女性卵巢储备

来源:生物谷 2014-09-21 09:59

2014年9月21日讯 /生物谷BIOON/ --罗氏(Roche)近日宣布,推出一款新的生育力检测试剂盒,用于评估女性卵巢储备功能(ovarian reserve,OR)。该款名为Elecsys AMH(anti-mullerian hormone,AMH,抗苗勒管激素)血液检测试剂盒,通过检测血液中AMH水平作为指标,评估女性卵巢储备功能。Elecsys AMH试剂盒是首个全自动化抗苗勒管激素(AMH)检测试剂盒,AMH是一种重要的生育能力标志物,医疗保健专业人员利用其评估女性卵巢储备水平。

根据世界卫生组织(WHO),生育问题困扰着约10%的夫妻,影响全球多达8000万人,而且这一数字还在不断上升。

AMH血液检测可在月经周期的任何一天进行,与卵泡刺激素(FSH)和雌二醇(estradiol)相比,AMH是评估卵巢储备的优异指标。此外,Elecsys AMH血液检测试剂盒可产生标准化的结果,而使用超声波评估卵巢储备时,评估结果通常依赖于操作者或诊所。

Elecsys AMH试剂盒的推出,将使医疗专业人员能够把AMH检测纳入常规临床实践,与传统方案及人工AMH检测相比,可更快的获得更可靠的检测结果。

罗氏诊断首席运营官Roland Diggelmann表示,此次Elecsys AMH试剂盒的推出,是体现罗氏关注女性健康领域,提高诊断的重要例子。

Elecsys AHM血液检测试剂盒将在欧洲、拉丁美洲、中东、非洲和亚洲所有接受CE标志的全部市场上市,但目前将不在美国和日本上市。

未来,Elecsys AMH试剂盒还将配合新的人重组促卵泡激素(rFSH)药物使用,该药目前正处于III期临床,由辉凌制药(Ferring Pharma)开发。该组合有望根据女性个体的AMH水平,提供rFSH个性化用药,为寻求通过试管婴儿受孕的夫妻,提供改善的选择。

关于卵巢储备(OR)和不孕不育:

卵巢储备功能,又称卵巢储备(ovarian reserve,OR),是指卵巢产生卵子数量和质量的潜能,间接反映卵巢的功能。生育力(fertility)指女性每个排卵周期妊娠的可能性。

正常女性生殖系统的受孕能力称为生育潜能。卵巢储备降低是指卵巢中的存留卵子量降到阈值以致影响了生育潜能,导致生育力低下。由于卵巢储备功能与生育和不孕症诊治关系密切,而日益受人关注。在体外受精与胚胎移植(IVF-ET)治疗过程中,控制性超排卵(COH)并获得多个成熟的卵子是治疗成功的关键,而COH的效果又取决于卵巢的反应性。卵巢的反应性主要由卵母细胞的数量和质量,即卵巢储备功能(OR)来决定。(生物谷Bioon.com)

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英文原文:Roche introduces a new fertility test for assessment of ovarian reserve for pregnancy

The new Elecsys anti-M¨¹llerian Hormone (AMH) fertility test increases the accuracy of ovarian reserve assessment compared to conventional methods

Roche today announced the launch of the Elecsys Anti-M¨¹llerian Hormone (AMH) blood test, the first fully-automated AMH test for assessing a woman¡¯s ovarian reserve. AMH is an important fertility marker used by healthcare professionals to assess ovarian reserve levels.

According to the WHO, fertility issues affect one in ten couples, up to 80 million people globallyi, and this number is rising.

The AMH blood test can be measured during any day of the menstrual cycle and is a superior indicator of ovarian reserve as compared to the follicle-stimulating hormone (FSH) and estradiol. In addition, the Elecsys AMH blood test produces standardized results for assessing ovarian reserve as compared with the use of ultrasound, in which the result is often dependent on the operator or clinic.

¡°The introduction of our Elecsys AMH test will enable healthcare professionals to incorporate AMH testing into routine clinical practice while getting more reliable results faster than conventional protocols and manual AMH assays. It is an important example of our focus on improving diagnostics in the area of women¡¯s health¡±, stated Roland Diggelmann, Chief Operating Officer of Roche Diagnostics.

The Elecsys AMH blood test will be available in all markets accepting the CE mark in Europe, Latin America, Middle East, Africa and Asia. The test is currently not available in the United States and Japan.

In the future, the Elecsys AMH assay is also intended to be used in combination with the new human recombinant follicle-stimulating hormone (human rFSH) treatment currently in phase III development at Ferring Pharmaceuticals. This combination, which will make possible individualized dosing of human rFSH based on a woman¡¯s specific AMH level, may provide an improved option for couples seeking to conceive through in vitro fertilization.

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