| 图片： | |
|---|---|
| 名称： | |
| 描述： | |
- 你认为HPV 检测有必要吗?
Please share your oppinion:
请分享你的观点
Recently I noticed this topic in another cytology website in China. Let us have a discussion here.
最近我在另一个中国的细胞学网站中注意到这个主题。让我们一起在这里讨论。
1. Are all cervical carcinoma related to HPV infection?
所有的宫颈癌都是由HPV导致的吗？
2. When the women or who should have high risk HPV (hrHPV) testing?
那些女性需要或者什么时候做高危HPV检测呢？
3. What methods to detect hrHPV do you used in your hospitals?
你们医院用的是那种方法检测高危HPV？
4. What should the women do if she has positive hrHPV result?
如果她的高危HPV的结果是阳性的，她们该怎么办？
5. hrHPV testing should be performed for women with AGC?
细胞学结果为AGC的女性应该进行高危的HPV检测吗？
6. Any question, experience or oppinion you have, please share or discuss.
所有以上问题，就你个人的观点或经验来分享和讨论吧。
We as pathologists should know some basic information about HPV even though HPV testing might not be oerformed in your hospital, or the patients might not be able to pay for the test.
即使HPV检测在你们医院没有开展或病人没有经济能力支付这项检测。我们做为病理学医生应该知道一些关于HPV的基本知识。
标签：
-
本帖最后由 于 2009-04-06 09:33:00 编辑
×参考诊断
| 以下是引用lingxg在2009-5-1 21:31:00的发言：
宫颈癌作为目前唯一的病因明确的人类恶性肿瘤，使其具有了可能通过筛查而减少的甚或消失的疾病。因此，筛查的意义毋庸置疑。PAP smear 在目前的客观条件下具有现实的意义。但PAP smear有一个致命的弱点：对于形态学的方法而言，所要求的条件太高，即在诊断环节的人员必须是专业的人员。对于庞大人群的普查而言，至少在中国是无法实现的。如果不能做到所有人群的普查，其意义有限。 其次，HPV做为宫颈癌发生的必要条件，理论上应该是没有HPV就没有宫颈癌，因此检测HPV的感染十分必要。个人认为，HPV检测后可以指导细胞学检测的计划，虽然目前人类对于病毒没有有效的手段阻止。 对于HPV检测后所带来的一系列问题，其实对于每个疾病都会遇到不同程度的这样那样的问题。所以现代医学已经从单纯的生物模式逐渐在向社会－心理－生物模式转变，更加重视心理健康和社会影响。其实对于疾病的预防，我认为除了对于疾病的早期发现外，更重要的还有一点是健康知识的传播，大众健康意识的培养。 “廉价的病例”，我不感苟同。中国人口众多，疾病谱完全，可是为什么疾病的命名鲜见中国人呢？这么多的新技术不断被发明、使用，可是我们自己为什么还以FDA马首是瞻呢？以WHO唯命是从呢？我们有那么多的科研者，那么多的高头衔的人，为什么总是在卖别人的成果呢？我们自己不能够有新的发现、新的技术，我们有必要阻止别人做吗？科学应该是无国界的，所谓的廉价的病例，不一样给这些廉价的病例带来了一定的好处吗？如果我们自己的技术要做实验的话，还是“廉价的病例”吗？ 作为筛查技术，应该具备：操作简单，费用低廉的可行性条件。因此随着对HPV检测手段的发展，最终应该是HPV检测技术取代PAP smear 技术。 纯属个人观点。 |
我在上面贴子说的“廉价的病例”只是对那些公司在发展中国家做科研的结果最后还操终实验科研说的;有些可能不了解;在发展中国家和发达国家同时做一个一样的临床科研所花费的费用相差悬殊10倍之多;并这些都是与一些国际上大型医疗公司相关(或赞助)的;他们隐瞒了一些我们不知道的实验目的；用我们的发展中国家很多科研不了解的东西在里面；他们不是做慈善。在发达国家病人的样本用于进一步临床科研（除了已经签字同意之后的科研）是必须经过病人签字同意才可以的。但是发展中国家很多制度的不完善 ；很多时候是不告诉病人的样本进行到那些科研研究的。至于您其他的论点我也没有什么反对的；但是对于HPV检测技术能否取代PAP smear 我持保留意见。因为现在的技术条件下HPV是宫颈癌致病确定的因素；但是是否还有其他的病因并没有搞清楚。
最后我在这里说：
1、中国需要自己的科研，是实事求是的；不是造假的；不是为了个人私利（即使是为了私利也是实事求是的基础之上；再考虑个人的私利）
2、中国有那么大的人口资源；有那么大的病例库；这是我们的优势；但是需要我们国家有完善的制度和必要的科研经费；最重要的是要有自己的人才培养计划；才能好好利用这些资源。
3、如果我们不想落后挨打，就应该吸取别人的长处为自己所用。
4、科学是无国界的，但是科研的人是有国籍的；他们接受的教育是有局限性的；这个世界上马克思是几百年才能出一个的；所以我们人的认知是有限的；首先我想到的是我是中国人；我希望我们自己的祖国会更好不时吗？谢谢！
- 掌心0164
-
本帖最后由 于 2009-05-02 19:06:00 编辑
 Thank Dr. lingxg .
This is very considerable and comprehensive discussion.  I like it.
I do not agree the term 廉价的病例 also. Some large clinical trials like to be perfomed in India, China or Aferia. There are several reasons I think, including population base and the selection of the control groups. 
For example:  HPV screeining  paper (above) just was published in New Engl J Med. 31,488 women were selected as control group without screening. This kinds of clinical trials will not be permitted to have in the usa or most european countries.
可是我们自己为什么还以FDA马首是瞻呢. Sure it is not necessary. FDA makes the rule for USA, not for other countries.
以WHO唯命是从呢？WHO is an international organization. We do not need to do all things as WHO suggested.  But medicine needs some standard for example, classification, terminology in the world for communication and patient care. If we have good system in China which can be used in all hospitals in China, this is good.
 In the USA there are big fight for primary cervical lesion screening, Pap test vs. HPV testing for all women older than 30, as Dr.  陈隆文 mentioned above. I still favor Pap test as primary screening method and reflex HPV testing for atypical squamous cells, AGC, or older women with LSIL in the USA. With the wide use of HPV vaccine for young girls, I agree screening approach may be change in the future.
From this web, I know the HPV testing is more than 300 RMB in China. This is too expensive for a lot of people in China.
If we have our own HPV testing method with good quality I think it will be much cheapter.
In China there should be more women with screening, even the conventional Pap (25 RMB, see above).
In fact many countries still use conventional Pap tests. I got the information from ThinPap company and psted in another topic.
UK and
 （英国和爱尔兰100%液基细胞学，67% TPPT, 33% SP）
 （英国和爱尔兰100%液基细胞学，67% TPPT, 33% SP）
（Benelux 60%液基细胞学，55%TPPT，余下主要是SP） 
Suisse 75% LBC, 60% TPPT, rest mainly SP 
Suisse 75% LBC, 60% TPPT, rest mainly SP 
 （瑞士75%液基细胞学，60% TPPT，余下主要是SP）
German 10% LBC, 60% TPPT 
 （瑞士75%液基细胞学，60% TPPT，余下主要是SP）
German 10% LBC, 60% TPPT 
 (德国10%液基细胞学，60%TPPT）
Nordic 15% LBC, 80% TPPT
 (德国10%液基细胞学，60%TPPT）
Nordic 15% LBC, 80% TPPT
（北欧15%液基细胞学，80%TPPT） 
 （澳大利亚100%传统涂片和25%自费加做TPPT）
NZ- 60% conventional 25 % TPPT and 15% other LBC
 （澳大利亚100%传统涂片和25%自费加做TPPT）
NZ- 60% conventional 25 % TPPT and 15% other LBC
（新西兰60%传统涂片、25%TPPT和15%的其他液基细胞学） 
For
For
 （对于中国，我们没有可靠的市场份额数据。）
from
 （对于中国，我们没有可靠的市场份额数据。）
from
Jeff Keene, Director Global Communications and Payer Relations,Hologic/Cytyc Corp
（Jeff Keene是赛迪公司全球联络部主任和付款联系人）
Anyway hope most of Chinese women will have cervical screening test because cervical cancer is a preventable cancer. Wish our China becomes stronger and stronger in all areas including medicine and pathology.
Thank Dr. lingxg again for your discussion. Welcome you visit here more often if you have time.
cz
非常感谢 Dr. cqzhao和掌心0164的关注和回复。可能话题已经不仅是Dr. cqzhao当初所提出的内容了。
首先，我个人认为讨论HPV检测的是有必要的。病原学的检测应该优于形态学检测，但不是说PAP smear 就可以不用，任何一项技术是否能被采用不仅仅因为技术本身的科学性，还要考虑到客观条件的限制。传统的巴氏涂片和液基细胞学各自有客观存在的条件。一项新的HPV检测技术－－Care HPV即将被使用，我了解的情况，一旦该项技术被使用，将会使宫颈癌的筛查成为可能。
其次，我所提的关于FDA和WHO分类的问题，因为我们现在的事实的确是这样，新技术的使用或药物的使用肯定是在FDA的认证后才会被推广开。国内的企业盯着FDA认证的产品进行仿制，国内的专家同样具有这样的情结，非FDA认证就不放心。当然深层次的原因不便多说。近年来病理界以WHO分类为准绳，无可厚非，就像宫颈细胞学一样，TBS一统天下，暂时不说我们能否提出被世界认可的某个标准，且说WHO或TBS的修改中国人参与了多少，我们有多少意见被这两个系统所采纳。也许我们知识盲目的跟在后面学，还没有完全学懂的时候，人家又有新的版本出来了。为什么呢？我曾经在学术会上听到过两位教授提出这样的问题：一位教授提到WHO在写宫颈癌防治手册（大概是这个计划吧）时，没有中国关于这方面的可信资料；另一位教授提到关于乳腺癌细胞学的文献好像只有阚秀教授发表在国内杂志上，国际杂志上找不到中国人发表的相关文献。我们应该做什么呢？我们应该怎么做呢？
关于科研的问题：前段时间我得知我的一位高中同学回到了国内某高校，我非常惊讶。 中国科学技术大学化学系、应用化学和管理科学双学士学位；香港大学化学系有机化学博士；美国哈佛大学医学院微生物和分子遗传学系博士后。我问她以后还搞科研吗？也许我的问题有点可笑，可我真的这样问了。为什么这样问呢？国内搞生物技术方面的科研，总让人感觉有点玄。很可惜，几百年出一个马克思还是爱因斯坦，至少没有中国人的份。生物技术的科研中国人还是先积累在说吧，你有成果也没有人相信。
爱国是必须的，我们的情结还是很重的，我们还是爱民族吧，要不我们这么多的海外的专家学者不是很麻烦吗？
“难道检测HPV像大家在开展液基细胞一样仅仅是诱惑而已吗？”对此我无话可说，还是因为我们太穷了，所以我们才会出现这样尴尬的问题。作为临床医生最大的成就感是看到病人康复，作为病理医生最大的成就感是我没有把别人误诊（疑难病例）。当有一天我们因为阻止了某一疾病的发生，如宫颈癌的发生，应该是所有人的最大成就感。所以我相信hpv的检测就宫颈癌而言十分有必要。
非常感谢各位的指点，水平有限，信口胡言，不适之处请多指正。
纯属个人观点。
- 服务病理
子宫颈癌快速筛查技术----care HPV技术有望极大减轻发展中国家子宫颈癌疾病负担
研究人员第一次在世界上验证了人乳头瘤病毒快速检测技术（care HPV）能够准确、快速地发现子宫颈癌及癌前病变，这一检测技术不仅只需两个多小时就能得出结果，而且费用也只有目前高收入发达国家与地区所使用检测方法的1/10。
英国《柳叶刀—肿瘤学》（The Lancet Oncology）杂志9月22日在线发表中国医学科学院肿瘤研究所、中国癌症基金会、江西省妇幼保健院等单位共同完成的一项最新研究成果。研究人员第一次在世界上验证了人乳头瘤病毒快速检测技术（care HPV）能够准确、快速地发现子宫颈癌及癌前病变，这一检测技术不仅只需两个多小时就能得出结果，而且费用也只有目前高收入发达国家与地区所使用检测方法的1/10。
HPV感染是子宫颈癌发生的必要条件
子宫颈癌是常见的妇科恶性肿瘤之一，发病率在女性恶性肿瘤中居第二位，仅次于乳腺癌。据世界范围统计，每年估计有46.6万的子宫颈癌新发病例，亚洲23.5万例，中国估计有近10万新发病例，约占世界新发病例总数的1/5。需要指出的是，每年新发的近50万子宫颈癌病例还只是冰山一角，据估计全球子宫颈癌高度癌前病变的妇女有1000万例，低度子宫颈病变的有3000万例。我国城市妇女由于缺乏有组织的筛查计划和医学知识同样也面临着子宫颈癌的严重威胁。特别是我国中西部农村，由于缺乏资金和医疗技术，子宫颈癌是妇女的主要卫生问题之一。我国每年约有3万名妇女死于子宫颈癌。
经过各国科学家长期不懈的努力，人们终于发现人乳头瘤病毒（HPV）是诱发子宫颈癌的元凶。研究表明，99.7%的子宫颈癌都可检测到高危HPV DNA，而HPV阴性者几乎不会发生子宫颈癌。大量的研究证据都说明，HPV感染是子宫颈癌发生的必要条件。目前有118种型别的HPV，2005年世界卫生组织（WHO）正式确认与子宫颈癌相关的高危型HPV有13种：16，18，31，33，35，39，45，51，52，56，58，59，66；可能对人类有致癌性的有4种，即5，6，8，11。
为了调查不同地区和不同妇女人群中HPV的情况以及与感染有关的危险因素，中国医学科学院肿瘤研究所、中国癌症基金会等研究单位自2004年起，开展了“中国妇女HPV感染和子宫颈癌（以人群为基础）的流行病学调查”，这是我国有关HPV感染情况的首次大人群、多中心研究。调查人群覆盖了我国4个农村地区（新密、襄垣、阳城和于田）和4个城市（北京、上海、沈阳和深圳），共有8000多名妇女参加了该研究，年龄范围从15岁至54岁。调查发现，我国城市和农村妇女的致癌型HPV感染率都较高，分别为15.2％和14.6％，因此目前我们很可能低估了我国的子宫颈癌疾病负担；同时HPV感染的年龄分布呈现两个高峰现象，这也使我国的子宫颈癌预防更具挑战性。
初筛可降低子宫颈癌的发病率和死亡率
子宫颈癌有一系列的癌前病变，它的发生发展是由量变到质变、渐变到突变的过程。由于确立了HPV感染是子宫颈癌发生的必要条件，HPV检测技术的发展极大地推动了子宫颈癌筛查的进步。
随着细胞学技术的改进，1996年美国FDA批准薄层液基细胞学技术用于子宫颈癌筛查，这一技术在识别病理高度病变的灵敏度和特异度分别达到87%和94%；降低了假阴性。以杂交捕获二代试验（hc2）为代表的HPV DNA检测法，其识别病理高度病变的子宫颈癌的灵敏度和特异度分别为95%和85%，可用于粗筛高风险人群。将薄层液基细胞学和hc2相结合，可显著提高识别子宫颈癌高度病变的灵敏度和特异度，大大降低假阴性率，98%以上的早期子宫颈癌的病人都可筛查出来。
为比较不同子宫颈癌筛查方法的灵敏度、特异度和成本效益，探索适于我国不同地区资源条件和人群风险度的合理的筛查方案，提高我国妇女子宫颈癌的防治水平，1999年我们开展了“中国山西子宫颈癌筛查方法的研究”。该研究也表明，HPV由于其高敏感度和高重复性，可用于子宫颈癌初筛；薄层液基细胞学和hc2是目前最有效的子宫颈癌初筛手段可用于子宫颈癌的早诊早治。此项研究结果在2000年法国巴黎举行的欧洲生殖道感染与肿瘤大会上报告并获得欧罗金国际奖。美国药品与食品监督管理局（FDA）根据此结果，首次批准可用检测HPV病毒的hc2技术来发现子宫颈癌与癌前病变。该技术迅速被发达国家与地区采用，挽救了无数妇女的生命。
2005年WHO发表声明称，有充足的证据表明：HPV DNA检测可作为子宫颈癌的初筛手段，并可以降低子宫颈癌的发病率和死亡率。在已建立了筛查制度的发达国家和一些发展中国家的流行病学资料显示，这些国家的子宫颈癌发病率和死亡率已经大幅度下降。
满足发展中国家需求的筛查技术
目前，子宫颈癌防治工作中存在的主要问题之一是缺乏经济有效的筛查和早诊早治方案。与发达国家妇女相比，发展中国家仅有少数妇女能够得到子宫颈癌癌前病变的筛查服务。由于现有的医学技术对子宫颈癌的发生率影响有限，因此降低子宫颈癌的死亡率有赖于行之有效的人群筛查。
巴氏涂片作为一种子宫颈癌的筛查方法应用已有半个多世纪，对子宫颈癌的防治作出了重要的贡献，但是，巴氏涂片需要建立高标准的细胞学检查系统，以及培养训练有素、能准确阅读巴氏涂片的细胞学技术人员，所需费用相当可观；另外，巴氏涂片的敏感度并不令人满意。此外，尽管醋酸染色观察法只需要10元人民币，是目前贫困地区子宫颈癌筛查的主要模式，但效果也不尽如人意。如果没有接受良好的培训，肉眼观察的假阴性和假阳性率可以高达40%和20%。薄层液基细胞学加hc2技术被认为是筛查子宫颈癌的最佳方法，但存在的唯一问题是，做一次这样的检测需要花费500多元人民币，它只适合我国的大中城市。HPV病毒的检测对防治子宫颈癌仍然至关重要，发展一种经济、准确、安全、有效的子宫颈癌筛查方法成为学术界和国际社会关注的焦点。
为研究和发展预防子宫颈癌的快速生化筛查技术，比尔及梅林达·盖茨基金会于2003年资助启动了全球多中心子宫颈癌防治与快速筛查技术合作研究（START China 2003-2007），本研究是第一个以临床结局为终点的HPV快速筛查研究。我们与美国健康适宜技术研究所（PATH）、德国QIAGEN公司等机构合作，历经5年在中国完成了这项筛查技术的临床研究，《柳叶刀—肿瘤学》发表了这一研究成果。
这项名为HPV快速筛查法（care HPV）的子宫颈癌筛查技术，假阴性率为10%，假阳性率为16%，在识别子宫颈癌与高度病变的敏感度和特异度方面比较令人满意，接近发达国家和地区普遍使用的hc2技术，而费用只是它的1/10。与现在普遍使用的两种子宫颈癌检测法相比，能够更加快速而准确地捕捉到由人乳头瘤病毒（HPV）导致的子宫颈癌及癌前病变，一般在两个半小时 左右即可快速筛查出结果。HPV快速检测筛查技术实验设施简单、操作容易，乡村卫生员经过基本训练就能很好地掌握这个技术，而且可以在没有水电的情况下操作。
作为一种面向低收入国家和地区的子宫颈癌预防的实用方法，HPV快速筛查技术被证明是安全、准确、可靠的，同时又能被妇女和保健工作者所接受，这一技术将主要用于子宫颈癌危害较大而资源条件又较差的地区，拥有广阔的应用前景，并有望成为资源贫乏地区公共卫生子宫颈癌预防计划中可负担的初筛方法。毫无疑问，将有更多的发展中国家和贫困地区的妇女受益于这一技术的推广应用，通过筛查实现子宫颈癌的早期发现和早期治疗，降低子宫颈癌的发病率和死亡率，减轻子宫颈癌所带来的疾病负担。目前世界卫生组织正在制定措施，以使大多数发展中国家能早日用上这一技术。比尔及梅林达·盖茨基金会将再投巨资，在全球33个国家的44个地区推广应用这一技术。
http://news.1m1m.com/html/shouye/qianyan/2008/10-07/2008100729376.shtml
- 掌心0164
-
本帖最后由 于 2009-05-02 19:40:00 编辑
CareHPV and HC2
The careHPV test is broadly based on the HC2 test with some important diff erences. The assay time is 2·5 h or less, compared with up to 6 h for HC2. The careHPV collection medium, unlike other collection media,contains no toxic chaotropic salts, but rather contains non-toxic surfactants and is specifi cally formulated for solubilisation of cervical specimens from the collection brush without any equirement for extended mechanical shaking. The capture microplates in HC2 are replaced by magnetic beads coated by a monoclonal antibody with high affi nity to RNA-DNA hybrids. Furthermore, the temperatures of some steps in the careHPV assay are increased to decrease the overall assay time by more than 2 h. The principle of the assay is as follows: target HPV DNA from lysed cells is denatured and hybridised to full-length complementary RNA, then captured by monoclonal antibodies coated on paramagnetic beads.The captured hybrids on the beads are detected by antihybrid monoclonal antibody conjugated to calf intestine alkaline phosphatase, which reacts with an added chemiluminescent substrate to produce light in pro portion to the number of bound alkaline phosphatase molecules along the hundreds of antigenic binding sites per target molecule. Specimen test fi ndings are expressed in relative light units (RLU) and compared with the mean RLU from a minimum positive control set at 1 pg/mL of HPV-16 DNA (expressed numerically as the cutoff ) resulting in a ratio, the RLU/cut-off , the proportion of which is indicative of clinical positivity. ecause the output signals of both HC2 and the new careHPV test are quite linear over a broad range around the cut-off -point ratio (RLU/cutoff ) of 1·0, there is the possibility to vary the cut-point by adjusting the calculations to indicate specimen positives at lower or higher values than the value of positive controls, thus a cut-point of 0·5 refl ects an assay that can score 0·5 pg/mL of HPV-16 DNA as positive.
如果能告诉我怎么把文档上传，我会把英国《柳叶刀—肿瘤学》（The Lancet Oncology）杂志9月22日在线发表中国医学科学院肿瘤研究所、中国癌症基金会、江西省妇幼保健院等单位共同完成的一项最新研究成果的全文传上来。
- 服务病理
-
本帖最后由 于 2009-05-02 20:04:00 编辑
Thank dear Lingxg and 0164,
I really appreciate your professional discusion. By discussion we can understand something, also can let more people know some important issues.I left China in 1992 and am the US citizen, but i always think China is my country. China does not allow the people to have dual citizens. If you want to become another country's citizen, you have to give up Chines citizen. This is bad rule. Anyway most Chinese aboard hope China become stronger and stronger.I am no doubt about this.
I did some pap hpv clinial studies and did the literature search for many times. There are some studies about Pap or HPV from China published in English journals. Many related papers are english abstract only like in Chinese Journal. In fact I saw many Japanese, korea studies.
一位教授提到WHO在写宫颈癌防治手册（大概是这个计划吧）时，没有中国关于这方面的可信资料；另一位教授提到关于乳腺癌细胞学的文献好像只有阚秀教授发表在国内杂志上，国际杂志上找不到中国人发表的相关文献。我们应该做什么呢？我们应该怎么做呢？
In fact above was that I gave a talk about breast FNA and core biopsy for diagnosis of breast lesion in cytpathology meeting in Guangzou in the end of March. I chose this topic because I knew that we still use the open biopsy with frozen for breast mass lesions in a lot of hospitals in China. I found rare related papers published in english journal from China even though FNA for breast lesions are used in some large hospitals in China even in 1970th, 1980th.
为比较不同子宫颈癌筛查方法的灵敏度、特异度和成本效益，探索适于我国不同地区资源条件和人群风险度的合理的筛查方案，提高我国妇女子宫颈癌的防治水平，1999年我们开展了“中国山西子宫颈癌筛查方法的研究”。该研究也表明，HPV由于其高敏感度和高重复性，可用于子宫颈癌初筛；薄层液基细胞学和hc2是目前最有效的子宫颈癌初筛手段可用于子宫颈癌的早诊早治。此项研究结果在2000年法国巴黎举行的欧洲生殖道感染与肿瘤大会上报告并获得欧罗金国际奖。美国药品与食品监督管理局（FDA）根据此结果，首次批准可用检测HPV病毒的hc2技术来发现子宫颈癌与癌前病变。该技术迅速被发达国家与地区采用，挽救了无数妇女的生命。
From above 子宫颈癌快速筛查技术----care HPV技术有望极大减轻发展中国家子宫颈癌疾病负担
I do not know the story in details, but I am sure it is not true. FDA approved HPV based on the one study in China?????? Maybe my chinese is bad and I misunderstand the meaning above.
Your comment is excellent. I like these kinds of discussion.
作为一个宫颈癌筛查的志愿者，我只希望有更好的方法能够汇集所有的女性，不论地位高低，不论贫穷与富有。This is great. Wish there are more people like you in China.
I feel bad for our Chinese people when I heard many things in China, for example, open biopsy with frozen for breast masses, frozen fro breast margins, uterine fibroid with frozen, CIN1, 2, 3 for hystectomy et al.
News reports often 夸大事实 in China and all other countries. I will do a little serach about careHPV.
By the way I just an associate professor of pathology, not a professor. I am more happy if people call me Dr. zhao, or zhao, or Cheng (chengquan is too difficult for American, so I ask then to call me cheng).
-
This is abstract about the paper mentioned above
A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China.
Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.
BACKGROUND: A new test (careHPV; QIAGEN, Gaithersburg, MD, USA) has been developed to detect 14 high-risk types of carcinogenic human papillomavirus (HPV) in about 2.5 h, to screen women in developing regions for cervical intraepithelial neoplasia (CIN). We did a cross-sectional study to assess the clinical accuracy of careHPV as a rapid screening test in two county hospitals in rural China. METHODS: From May 10 to June 15, 2007, the careHPV test was done locally by use of self-obtained vaginal and provider-obtained cervical specimens from a screening population-based set of 2530 women aged 30 to 54 years in Shanxi province, China. All women were assessed by visual inspection with acetic acid (VIA), Digene High-Risk HPV HC2 DNA Test (HC2), liquid-based cytology, and colposcopy with directed biopsy and endocervical curettage as necessary. In 2388 women with complete data, 441 women with negative colposcopy, but unsatisfactory or abnormal cytology or who were positive on HC2 or the new careHPV test, were recalled for a second colposcopy, four-quadrant cervical biopsies, and endocervical curettage. An absence of independence between the tests was not adjusted for and the Bonferroni correction was used for multiple comparisons. FINDINGS: Complete data were available for 2388 (94.4%) women. 70 women had CIN2+ (moderate or severe CIN or cancer), of whom 23 had CIN3+. By use of CIN2+ as the reference standard and area-under-the-curve analysis with a two-sided alpha error level of 0.0083, the sensitivities and specificities of the careHPV test for a cut-off ratio cut-point of 0.5 relative light units, were 90.0% (95% CI 83.0-97.0) and 84.2% (82.7-85.7), respectively, on cervical specimens, and 81.4% (72.3-90.5) and 82.4% (80.8-83.9), respectively, on vaginal specimens (areas under the curve not significantly different, p=0.0596), compared with 41.4% (29.9-53.0) and 94.5% (93.6-95.4) for VIA (areas under the curve significantly different, p=0.0001 and p=0.0031, for cervical and vaginal-specimen comparisons for the careHPV test, respectively). The sensitivity and specificity of HC2 for cervical specimens were 97.1% (93.2-100) and 85.6% (84.2-87.1), respectively (areas under the curve not significantly different from the careHPV test on cervical specimens, p=0.0163). INTERPRETATION: The careHPV test is promising as a primary screening method for cervical-cancer prevention in low-resource regions.
-
本帖最后由 于 2009-05-02 21:56:00 编辑
QIAGEN:
- Launch of QIAsymphony SP, the first system in a series of modular instruments which can be integrated to automate entire workflows – from sample to result. It is the result of the largest development program ever undertaken by QIAGEN.
- QIAGEN merges with Digene Corp., creating the market and technology leader in molecular diagnostics.
- QIAGEN introduces QIAcube, a revolutionary platform which fully automates the processing of QIAGEN consumable products.
- QIAGEN acquires a Multiplexing Assay Technology, which allows for the testing of multiple pathogens in one single run.
- QIAGEN formally establishes its Asia regional headquarters in Shanghai.
- QIAGEN acquires a leading position in molecular diagnostics by adding various sets of PCR-based molecular tests to its portfolio.
- Development of the artus Influenza-Kit for the rapid detection of all known variants of the Avian Flu virus H5N1.
- QIAGEN receives world’s first governmental clearance for an Avian Flu assay (through its subsidiary PG Biotech in China).
- QIAGEN launches the first human whole genome siRNA set worldwide. SiRNAs are little RNA molecules which silence specific genes by inhibiting their expression. This mechanism prevents the synthesis of final proteins, which could cause certain diseases.
- QIAGEN’s QIAamp becomes the world’s first stand alone product for sample preparation to receive the CE-label.
- QIAGEN re-locates its US headquarters from Valencia/ Ca. to Germantown/ Md.
- Launch of PAXgene, the first product that consolidates and integrates key steps of sample collection, stabilization and purification
- PreAnalytiX, a joint venture with Becton, Dickinson and Company, established.
- The FDA approves Digene’s hc2 high-risk HPV DNA test for follow-up evaluation in women with inconclusive Pap results. 4 years later, the FDA approves the HPV test for routine screening in women age 30 and older.
- With the acquisition of Rosys AG, Switzerland (today: QIAGEN Instruments), QIAGEN moves to integrate its automation business.
- Initial Public Offering, Deutsche Boerse (Prime Standard), Frankfurt.
- QIAGEN N.V. (Holding) established in Venlo, The Netherlands.
- Initial Public Offering, NASDAQ, New York.
- QIAGEN introduces the BioRobot 9600, its first benchtop workstation which automates purification technologies and still forms the basis of the HPV test.
- QIAGEN revolutionizes molecular biology by introducing the first “Plasmid-Kit.“ The discovery reduces the time needed for the preparation of plasmids, little ring-formed DNA molecules of a bacteria’s cell, from 2-3 days to 2 hours.
- QIAGEN founded in Duesseldorf, Germany
Corporate History — Milestones and Highlights
QIAGEN was founded 1984 as a spin-off at the University of Düsseldorf. Since then the company has continuously developed and turned into what is today the world's leading provider for innovative sample and assay technologies for research in molecular diagnostics, applied testing, pharma and academic research.
| 2008 |
|
|
| 2007 |
|
|
| 2006 |
|
|
| 2005 |
|
|
| 2004 |
|
|
| 2002 |
|
|
| 2001 |
|
|
| 1999 |
|
|
| 1998 |
|
|
| 1997 |
|
|
| 1996 |
|
|
| 1986 |
|
|
| 1984 |
|
|
-
本帖最后由 于 2009-05-02 22:33:00 编辑
“By the way I just an associate professor of pathology, not a professor. I am more happy if people call me Dr. zhao, or zhao, or Cheng (chengquan is too difficult for American, so I ask then to call me cheng).”很感动，对于Dr. zhao的这个说明，以后我会注意的。
“care HPV”其实是QIAGEN公司，也就是HC－2的那个公司发明的一个方法，在中国和印度做临床试验，去年完成。中国的试验是由乔友林教授主持完成的，我由于一直在关注宫颈癌筛查的进展，所以也自然而然的对此特别关注，并且有幸聆听了乔教授关于此试验的报告。媒体总是在报告的时候会或多或少的夸大事实，可能与新闻工作人员的专业知识缺乏而又不去认真求证有关，当然不能排除某些人有一定的目的。Dr. zhao的实事求是的态度我认为正是我们所缺乏的。
很荣幸和Dr. zhao的交流，作为后学之人，再次表示感谢！同时对华夏病理网提供这样一个好的交流平台表示感谢！
- 服务病理
HC2 is the product of Digen.
In 2007
Digene and QIAGEN Merger
Digene has now merged with QIAGEN to create one, combined company that will be a market and technology leader in molecular diagnostics. Visit qiagen.com for corporate information and theHPVtest.com for HPV/HPV testing information.
So HC2 and careHPV are the product of the same company, now called QIAGEN
March 2000:
FDA approved HC2 test for women with abnormal Pap test.
March 2003:
FDA approved to allow HC2 test to be used for screening, in conjunction with the Pap test, of women over age 30 for HPV infection. It should be used along with the Pap test, a complete medical history and an evaluation of other risk factors to help physicians determine what kind of follow-up is necessary.
Below for detailded FDA news.
FDA News
|
FOR IMMEDIATE RELEASE |
Media Inquiries: 301-827-6242 |
FDA Approves Expanded Use of HPV Test
The Food and Drug Administration (FDA) today approved expanded use of a laboratory test to detect the presence in women of human papillomavirus (HPV), one of the most common sexually transmitted infections.
There are more than 100 types of HPVs. The test, the HC2 High-Risk HPV DNA Test, manufactured by Digene Corp., of Gaithersburg, Md., can identify 13 of the high-risk types associated with the development of cervical cancer. The HPV DNA test does not test for cancer, but for the HPV viruses that can cause cell changes in the cervix. If left untreated, these changes can eventually lead to cancer in some women.
FDA initially approved the HPV DNA test in March 2000 for testing women who had abnormal Pap test results to determine whether they needed to be referred for further examination. The new indication allows the test to be used for screening, in conjunction with the Pap test, of women over age 30 for HPV infection. It should be used along with the Pap test, a complete medical history and an evaluation of other risk factors to help physicians determine what kind of follow-up is necessary.
“Knowing whether or not a woman is infected with high-risk HPV is added information that will help physicians detect and treat early cell changes that might eventually lead to cervical cancer,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “FDA is committed to bringing safe and effective new technologies to the market quickly.”
Up to 20 percent of the sexually active U.S. population is believed to be infected with HPV at any one time. Most women who become infected with HPV are able to eradicate the virus and suffer no apparent long-term consequences to their health. But a few women develop a persistent infection that can eventually lead to pre-cancerous changes in the cervix.
The HPV DNA test, like the Pap test, is performed by collecting cells from the cervix and then sending them to a laboratory for analysis. The test detects high-risk types of HPV in cell DNA even before there are any conclusive visible changes to the cervical cells.
Women who have normal Pap test results and no HPV infection are at very low risk (0.2%) for developing cervical cancer. Women who have an abnormal Pap test and a positive HPV test are at higher risk (6%-7% or greater) of developing cervical cancer if not treated.
FDA approved the expanded use of the test based on published literature describing studies of a cross section of women with normal and abnormal Pap test results who tested positive or negative for high-risk types of HPV. FDA also took into account additional input from professional societies, FDA advisory panel members and other interested parties in arriving at a decision.
The HPV DNA test is not intended to substitute for regular Pap screening. Nor is it intended to screen women under 30 who have normal Pap tests. Although the rate of HPV infection in this group is high, most infections are short-lived and not associated with cervical cancer.
Some 50 million women get Pap tests annually in the United States. According to the American Cancer Society, in 2003, 12,200 women will be diagnosed with cervical cancer and 4,100 will die from the disease. With proper screening, cervical cancer is avoidable and, if caught early, curable.
