罗氏AMH-检测的医学价值和竞争优势.pptx

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录,罗氏,AMH,的,竞争优势,3,罗氏,AMH,的检测特性,2,不孕不育,/,卵巢储备检测方法和,AMH,医学价值,1,5000,万不孕不育患者，女方因素居多,2009,年中国不孕不育发病率,15%,约,5000,万不孕患者,输卵管原因,(8%),排卵功能障碍,(7%),卵巢储备减少,(11%),子宫内膜异位,(5%),子宫因素,(1%),女性其他多重因素,(11%),男女其他多重因素,(18%),男性因素,(18%),其他原因,(8%),不明原因,(13%),按,WHO,定义，女方因素占,45-55%,，以,25,岁至,30,岁人数最多，其中适龄女性排卵功能障碍最为多见。,1.CDC.Assisted reproductive technology success rates:national summary and fertility clinic reports,2010.,2.Forti&Krausz.J Clin Endocrinol Metab 1998,首诊,:,不孕不育的病因检查,女性内分泌激素检查,:,性激素,6,项,SHBG,DHEAS,INS,C,肽,TSH,男性内分泌激素检查,:T,SHBG,FSH,LH,E2,生精功能,精液,排卵,子宫和输卵管,卵巢储备,腹腔镜,男,女,不孕不育的病因诊断,Clinical Guideline,Nice Feb 2004:,Fertility:assessment and treatment for people with fertility problems,男科,妇科,性激素,6,项,:E2,P,FSH,LH,PRL,T,不孕的基础内分泌激素检测,不孕,:,一年,未采取任何避孕措施，性生活正常而没有成功妊娠,。,2004 NICE,指南：,不孕夫妇男女双方都需,基础内分泌,激素,检测,女：排卵,(E2/P/FSH/LH/T/,甲功）、,卵巢储备（,AMH,）,男：生精（,FSH/LH/T,）,Clinical Guideline,Nice Feb 2004:Fertility:assessment and treatment for people with fertility problems,E2,P,Testo,FSH,LH TFT,Testo,FSH,LH,不孕夫妇的临床检查,辅助不孕不育的病因诊断,1,2,协助辅助生殖技术,(ART),的治疗监测,激素检测在不孕不育诊疗的目的,2,常用,的卵巢储备检测,指标,激素测定,基础,FSH,基础,E2,B,超,窦卵泡计数（,AFC,）,卵巢储备常用,检测方法,的不足,20 October 2025,page,10,2009 Roche,基础,FSH,和,E2,月经第,3,天检测,周期内和周期间,差异,临床,灵敏度低，可靠性低,（正常浓度不能排除卵巢储备下降）,窦卵泡计数,（,AFC,）,月经第,3,天检测,周期内和周期间,差异,，,操作者,/,地点之间,差异,灵敏反映卵巢储备，预测卵巢刺激反应,检测时间,差异度,灵敏度,AMH,是准确反映卵巢储备功能的,最佳指标,AMH,是由卵巢内生长中的窦前卵泡和小的窦卵泡分泌。每个卵泡含有一个卵子,Visser,J et al.Reproduction.2006;131:1-9.,Van Disseldorp J,et al.,Human Reprod,.2010:25:221227.,3,.Hansen KR et al.Fertil Steril.2011;95:170-175.,卵泡池的大小,在女,性出生时已经确立,.,1,血,AMH,水平反映,卵巢储备,功能,2,3,:,低,AMH-,卵巢储备力低,.,高,AMH,卵巢储备力高,卵巢,储备,指始,基卵泡,池内可,募集的卵泡,数,量。反映女性,的,生育,能力,.,卵泡,池的大小,随,年龄下降,.,1,卵巢储备检测指标比较,-,AMH,优,于基础,FSH,AFC,20 October 2025,page,12,2009 Roche,基础,FSH,和,E2,月经第,3,天检测,周期内和周期间,差异,临床,灵敏度低，可靠性低,（正常浓度不能排除卵巢储备下降）,窦卵泡计数,（,AFC,）,月经第,3,天检测,周期内和周期间,差异，,操作者,/,地点之间差异,灵敏反映卵巢储备，预测卵巢刺激反应,AMH,月经周期,任意一天,检测,周期内和周期间,差异小,不受操作者,影响,灵敏、可靠,反映,卵巢,储备,预测卵巢刺激反应,检测时间,差异度,灵敏度,AMH,检测在月经周期的任何一天，周期内差异小,AMH(ng/mL),月经期,卵泡期,黄体期,4.0,3.5,3.0,2.0,2.5,1.5,AMH,雌二醇,孕酮,Kissell,et al,Hum Reprod,2014,排卵期,AMH,检测,在月经周期的任何,一天，周期内差异小,月经期,卵泡期,排卵期,黄体期,AMH(ng/mL),4.5,1.0,0.5,4.0,3.5,3.0,2.0,2.5,1.5,5.0,0.0,20,岁,2125,2630,3135,35,Kissell,et al,Hum Reprod,2014,AMH(ng/mL),月经期,卵泡期,黄体期,4.0,3.5,3.0,2.0,2.5,1.5,AMH,雌二醇,孕酮,排卵期,AMH,预测获卵数的准确性,优于,AFC,HP-hMG,rFSH,HP-hMG,rFSH,Arce,et al Fertil Steril 2013,获卵数（个,),获卵数（个,),P0.01,P=0.125,AMH,预测卵巢反应，指导,IVF,个体化治疗,AMH(pmol/L),拮抗剂,（,hCG/GnRHa,）,触发,标准,治疗,最大化,获卵,40,20,7,1,Nelson,et al,Hum Reprod,2009,Yates,et al,Hum Reprod,2011,高,反应,正常,反应,低,反应,可忽略,AMH,预测卵巢,反应，指导,IVF,个体化治疗,AMH(pmol/L),40,20,7,1,用,AMH,检测前,活产率,(%),30,25,20,15,10,用,AMH,检测后,Nelson,et al,Hum Reprod,2009,Yates,et al,Hum Reprod,2011,高,反应,正常,反应,低,反应,可忽略,拮抗剂,（,hCG/GnRHa,）,触发,标准,治疗,最大化,获卵,AMH,用于预测,卵巢过度,反应,预测卵巢过度反应,AUROC,95%CI,Age,0.60,0.57,0.64,AMH,0.81,0.77,0.84,Age&FSH,0.69,0.66,0.72,Age&AFC,0.76,0.72,0.80,Age&AMH,0.80,0.76,0.84,Age&AMH&AFC,0.80,0.74,0.86,Age&AMH&AFC&FSH,0.81,0.75,0.86,灵敏度,特异,度,IMPORT consortium,Hum Reprod Update,2013,EXPORT consortium,Fertil Steril,2013,AMH,提高,IVF,治疗的有效性和安全性,AMH,预测卵巢,反应,选择,GnRH,类似物,选择促性腺激素,更高活产率,更低,OHSS,2013NICE,指南：,AMH,检测卵巢储备，预测卵巢刺激反应,NICE,Clinical Guideline-Fertility assessment and treatment for people with fertility problems,2013.,NICE,Clinical Guideline-Fertility assessment and treatment for people with fertility problems,2013.,2011 ESHRE,共识：,AMH,检测卵巢储备功能，最,灵敏和,特异预测卵巢反应,ESHRE consensus on the,definition of,poor response to,ovarian stimulation,for in vitro fertilization,:the,Bologna criteria,Human Reproduction,Vol.26,No.7 pp.16161624,2011,ESHRE,：欧洲人类生殖与胚胎学会,目 录,罗氏,AMH,的,竞争,优势,3,罗氏,AMH,的检测特性,2,不孕不育,/,卵巢储备检测方法和,AMH,医学,价值,1,Elecsys,AMH,检测参数,1,样本量,50 L,样本物质,血清，,肝素锂血浆,18,分钟,总检测时间,(TAT),检测类型,自动化,精密度,溯源,贝克曼第,2,代,AMH ELISA,法,(,未修正,),可测范围,LoD 0.01 ng/mL(0.071 pmol/L);LoQ 0.03 ng/mL(0.214 pmol/L),.Gassner,D,Jung R.First fully automated immunoassay for anti-Mllerian hormone.,Clin Chem Lab Med,.,2014,检测范围,0.01 ng/mL-23.0 ng/mL(0.071-164 pmol/L),稳定性,在机,:8,周,5%,罗氏,AMH,与,AFC,一致性高,，,准确,预测卵巢储备,Elecsys,AMH,/AFC,相关性,Anti-Mllerian Hormone.Elecsys and,cobas e,analyzers package insert 2014.,Elecsys,AMH,和,AFC,一致性高,:,Spearman,系数,=0.68,AFC,n,Elecsys,AMH,ng/mL,罗氏研究,no.RD001542,n=451,女性,(1844,岁,),7,个中心,(6,个欧洲,1,个澳洲,),罗氏,AMH,检测比,Elisa,法低浓度检测,更,灵敏,Beckman Coulter(,修正版,),Ansh Labs,Elecsys,AMH,检测与,Elisa,法检测的,AMH,（贝克曼、,Ansh Labs,）呈良好的一致性，检测下限浓度更低,20-25%,1,1,D.Gassner,R.Jung(2014).,Clin Chem Lab Med 0(0):1434-6621,Elecsys,AMH,2.3 ng/mL,AMH Gen II,3 ng/mL,Elecsys,AMH,1 ng/mL,Ansh Labs AMH,2 ng/mL,罗氏,AMH,检测比,Elisa,法,精密,度更优异,欧洲,5,个实验室参加的多中心分析,*,全自动,Elecsys,AMH,检测比常规的,ELISA,检测显示更优秀的精密度，,Elecsys,AMH CV 15,数量,AMH 0.681 ng/mL,63.2%,32.4%,4.4%,68,0.681 ng/mL 2.27 ng/mL,1.4%,24.1%,74.5%,216,数量,66,169,216,451,在,1,个多中心研究中，根据,AFC,经验值,(7,，,15,1-3,),定义低，正常，高,3,个,AFC,亚组,相应,的罗氏,AMH,分组,一致性比率也列入表中,如,.,某患者,AMH 0.681 ng/mL,，低,AFC(07),的概率为,63.2%,，高,AFC,（,15,）,概率为,4.4%,低,1,2,正常,高,1,2,低,1,2,正常,高,1,2,这些数据可能对临床使用,AMH,和,AFC,评估时方法转换时有帮助,.,如果,AFC,结果变异大,每一实验室应将这些数据结合实验室自身条件进行转换,目 录,罗氏,AMH,的竞争,优势,3,罗氏,AMH,的检测特性,2,1,不孕不育,/,卵巢储备检测方法和,AMH,医学,价值,罗氏,AMH,更早期,/,准确,预测,卵巢,储备的变化,1,.,With courtesy of De Geyter C.,University Womens Hospital,Basel,unpublished,2,.,Anti-Mllerian Hormone.Elecsys and,cobas e,analyzers package insert 2014.,Spearman,系数,=0.68,AFC*,n,Elecsys,AMH,ng/mL,Elecsys,AMH,和,AFC,一致性高,准确检测卵巢储备功能,AMH,比,bFSH,bE2,更灵敏反映低,AFC,变化,罗氏研究,no.RD001542,n=451,女性,(1844,岁,),7,个中心,(6,个欧洲,1,个澳洲,),罗氏,AMH,更稳定,/,可靠,的,衡量超促排卵时,卵巢的,反应,Schiettecatte J,et al.,Presented at IFCC WorldLab Congress,Istanbul June 2014.,*,根据,CLSI protocol(CLSI-EP5),欧洲,5,个实验室参加的多中心分析,*,全自动,Elecsys,AMH,检测比常规的,ELISA,检测显示更优秀的精密度，,Elecsys,AMH CV5%,1,罗氏,全自动,AMH,，,重复性,、,操作方便,优于,ELISA,法,1.Gassner D,Jung R.Clin Chem Lab Med 2014;,doi:10.1515/cclm-2014-0022.Epub ahead of print;2.Anti-Mllerian Hormone.Roche Elecsys and,cobas e,analyzers package insert 2014,;3.,Rustamov O,et al.Hum Reprod 2012;27:30853091;4.Kumar A,et al.J Immunol Methods.2010;362:5159;5.Beckman Coulter AMH Gen II ELISA package insert 2013;6.Immunotech AMH(Beckman Coulter)package insert 2012.Available at:,2012-06-05_GB.pdf,(Last accessed June 2014);7.,AnshLabs product guide.Available at:,accessed June 2014);8.AnshLabs UltraSensitive AMH/MIS ELISA package insert.Available at:,accessed June 2014);9.,AnshLabs picoAMH ELISA package insert.Available at:,accessed June 2014).,Elecsys,Roche AMH,1,2,Beckman Coulter,AMH Gen II ELISA,3-5,Immunotech AMH,(Beckman Coulter),6,*,AnshLabs,UltraSensitive,7,8,*,AnshLabs,picoAMH,7,9,*,检测类型,全自动,手动,手动,手动,手动,CV,5%,8%,14%,6%,6%,最少标本量,50 L,60 L,25 L,25 L,100 L,检测时间,18,分钟,3,小时,3,小时,2.5,小时,4.5,小时,检测低限,0.01 ng/mL,(0.071,pmol/L),0.08 ng/mL,0.14 ng/mL,0.023 ng/mL,0.0012 ng/mL,检测范围,0.01 23.0 ng/mL(,0.071 164 pmol/L),0.08 21 ng/mL,0.14 21 ng/mL,0.084 14.2 ng/mL,0.03 0.75 ng/mL,Elecsys,AMH 9,大的,特点,和,利益,1.,全自动检测,1,2,避免,AMH,手工法导致的操作者,/,实验室间的差异,5,6,7.,年龄特异性参考范围,1,7,有助根据,AMH,检测结果对不孕患者进行辅导,7,2.,高精密度和灵敏度,2-4,提供可靠，一致的，可重复的检测结果准确评估卵巢储备,3.,检测范围宽,/,检测下限低,1,2,准确检测高,/,低极限值，预测卵巢过低,/,过高反应,4.,样本稳定,2,冰冻和新鲜样本等效,不需样本的预稀释,运输和储藏的样本仍稳定,5.,快速检测,1,2,在不孕资讯当天提供检测结果，尽快开始治疗,优化实验室资源等,8.,同,一,平台多种检测,1,AMH,在,Elecsys,/cobas,轻松检测,:,可在,Elecsys,e411,MODULAR,ANALYTICS,E170,cobas e,601 and,cobas e,602,平台检测,整合入常规,检测,可整合在同一平台,可流水线检测,操作,6.,批,间差异度,小,1,2,适于准确的长期监测,(,一致的检测结果可维持长时间,),9.,与,AFC,一致性高,8,许多医院进行,AMH,和,AFC,对照研究证实：罗氏,AMH,检测和卵巢储备的,AFC,值一致,Elecsys,technology brochure.Available at:,accessed June 2014);,2.Gassner D,Jung R.Clin Chem Lab Med 2014;,doi:10.1515/cclm-2014-0022.Epub ahead of print;3.,Schiettecatte J et al.,Presented at IFCC WorldLab Congress,Istanbul,Turkey,2226 June 2014;4.,Klemt V,Hofmann V,Gassner D.,Presented at ESHRE Annual Meeting,Munich,Germany,29 June to 2 July 2014;5.,Rustamov O et al.Hum Reprod 2012;27:3085-3091;6.Zuvela E et al.Reprod Biol 2013;13:255257;7.Nelson SM et al.Fertil Steril 2011;95:736-741 e731733;8.,Anti-Mllerian Hormone.Roche Elecsys and,cobas e,analyzers package insert 2014.,全自动,AMH,罗氏,贝克曼,检测时间,18,分钟,39,分钟,样本量,50uL,20uL,样本类型,血清,/,肝素锂血浆,血清,/,肝素锂血浆,校准,2,6,QC,2,3,包装,100,50,精密度,0.5 ng/mL 5%,0.16ng/mL 10%,LoD,0.01 ng/mL,/=0.02 ng/mL,LoQ,0.03 ng/mL,/=0.08 ng/mL,钩状效应,1400ng/mL,260ng/mL,检测平台,Elecsys,，,Cobas e,Access,2,罗氏全自动,AMH,检测,重复性,，,操作方便,优于,贝克曼全自动,罗氏，贝克曼,AMH,说明书,罗氏全自动,AMH,的上市，区分竞争对手,全自动,生殖激素,检测丰富,的菜单,全自动,生殖激素检测菜单,手工免疫检测菜单,全自动,生殖激素检测菜单,全自动,AMH,检测,无,AMH,检测,手工,AMH,检测,手工,AMH,（目前）,/,全自动,AMH,检测,(,即将上市,),Beckman Coulter Immunoassay Systems Test Menu.Available at,accessed July 2014)2.Siemens Immunoassay Systems.Available at,accessed July 2014)3.Abbott Test Menu.Available at,accessed July 2014),AMH,完善罗氏生殖激素菜单，提高检测效率,IM,检测项目,罗氏,贝克曼,西门子,雅培,E2,V,V,V,V,P,V,V,V,V,FSH,V,V,V,V,LH,V,V,V,V,PRL,V,V,V,V,T,V,V,V,V,-HCG,V,V,V,V,HCG,急诊,V,SHBG,V,V,V,V,DHEA-S,V,V,V,V,AMH,全自动,Elisa/,全自动,甲功（,10,项）,V,Elecsys,AMH,在不同目标客户的医学价值,妇科内分泌,生殖中心,检验科,更早、,更,准,地预测卵巢储备的,变化,稳定不受周期影响,的,AMH,更便利,于个体化治疗,检测,更高效,，,首,个上市的自动化,AMH,完善罗氏生殖激素检测,菜单,AMH,推广,工具,目标科室,目标客户,名称,关键信息,妇科,/IVF/,检验科,医生,DA,解读,AMH,的临床医学价值,妇科,/IVF/,检验科,医生,Reprint,AMH clinical,paper meta-analysis,妇科,/IVF/,检验科,医生,Seminar,slides,解读,AMH,的临床医学价值,妇产,/IVF/,检验科,医生,Video,解读,AMH,的临床价值，宣传罗氏妇女健康，,全,panel,整合推广,和领导地位,生殖内分泌,妇科,病人,Poster,首个,全自动,AMH,检测准确评估卵巢储备,上市,生殖内分泌,妇科,病人,Brochure,关爱女性：如何,评估卵巢垂体功能，辅助生殖内分泌疾病诊断治疗监测,产,品销售专家,Medical value,推广你准备好了么？,产,品讲解员,社交活动家,代表：,产品的添加剂，了解产品鲜活的形象和优势特点,客户：,随着深入的了解，随之产生,使用,动机，逐渐形成,使用,习惯,代表：,销售催化剂，直接带来医生对产品的兴趣,客户：,很难介入客户处方习惯的产生过程,代表：,以满足客户业余生活需要,客户,:,：,主要获得个人利益满足,.,Text,代表：,代表了产品的价值，是“专业帮手”,客户：,全面获得指导和信息快捷准确信息服务,40%,50%,8%,2%,专业化销售代表,总结,AMH,是评估卵巢储备功能的最佳指标，获国际权威指南推荐,罗氏,AMH,更早期,准确评估卵巢储备,罗氏全自动,AMH,检测重复性和操作方便优于,ELISA,法和贝克曼全自动,Doing now what patients need next,Email:shirley.shen,Cellphone:18616358436,