[英文新闻][更正]西门子公司推出Centaur乙肝表面抗原定量设备

StephenW

这是一个质性(qualitative)系统，它不是一个定量(quantitative)的系统。但它可以更好检测到变异(mutants)的范围。
[StephenW 11/06/2011]

http://www.laboratorynetwork.com/article.mvc/Siemens-Healthcare-Diagnostics-Introduces-0001
Siemens Healthcare Diagnostics Introduces ADVIA Centaur HBsAgII        

May 25, 2011

   
   
                          Siemens Healthcare Diagnostics has introduced its second generation in-vitro immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA, heparin, citrate) using the ADVIA Centaur® and ADVIA Centaur® XP systems.
西门子医疗诊断公司推出了第二代 体外 免疫之定性检测,对人血清和血浆中的乙型肝炎表面抗原（EDTA的，肝素，柠檬酸）（HBsAg）, 应用ADVIA®和ADVIA Centaur
® XP系统。

"The new ADVIA Centaur HBsAgII assay offers leading analytical and clinical sensitivity to common HBsAg subtypes, resistance to HBsAg a-determinant mutations and excellent specificity, combined with all the productivity benefits of ADVIA Centaur immunoassay systems," states Sarah Holt, Marketing Manager for Infectious Diseases at Siemens Healthcare Diagnostics.
  The new HBsAgII assay will replace the existing HBsAg assay on the ADVIA Centaur systems.  It can be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic Hepatitis B infection.  The assay may also be used to screen for Hepatitis B infection in pregnant women to identify neonates at risk of acquiring Hepatitis B during the perinatal period.
Currently two billion people worldwide are infected with the Hepatitis B Virus (HBV) and an estimated 600,000 people die each year due to acute or chronic consequences of this disease especially in Asia and Africa.*  It can be easily treated and healthy adults that are infected can recover with the result of lifelong immunity.  Carriers of HBV can remain highly infectious and are a potential source of new infections.  The chronically infected may suffer serious health consequences such as high risk of liver cirrhosis, liver cancer and may require a liver transplant as a last resort.
SOURCE: Siemens Healthcare Diagnostics

StephenW

西门子医疗诊断公司推出了第二代体外免疫对乙型肝炎表面抗原人血清和血浆（EDTA的，肝素，柠檬酸）（HBsAg）之定性检测中的应用ADVIA®和ADVIA半人马半人马® XP系统。

“新ADVIA半人马HBsAgII提供领先的分析检测及临床常见的乙肝表面抗原亚型的敏感性，抗乙肝表面抗原的A -行列式突变和优秀的特异性，与所有的免疫系统的ADVIA半人马生产效益相结合，“国家莎拉霍尔特，市场营销经理传染病西门子医疗诊断疾病。

新HBsAgII法将取代对ADVIA半人马系统现有乙肝表面抗原检测。它可以用来与其他信息结合血清学和临床诊断急性或慢性乙型肝炎感染者。该法也可用于B型肝炎病毒感染的孕妇在屏幕上，以确定收购在围产期新生儿B型肝炎的危险。

目前，全球有二十亿人感染乙型肝炎病毒（HBV）的，估计每年有600,000人死于这种疾病因急性或慢性后果，特别是在亚洲和非洲.*它可以很容易地治疗，健康的成年人被感染可以恢复与终身免疫的结果。乙肝病毒携带者可以保持高度传染性，并且是潜在的新的感染源。可能遭受的慢性感染，如肝硬化，肝癌高危险严重的健康后果，可能需要作为最后的手段肝脏移植手术。

来源：西门子医疗诊断

donghufen

还不知道哪年能拿到中国的注册证呢

StephenW

回复 donghufen 的帖子

这一点，我不知道。我们可以问版主Interdetect。但我相信应该很快，因为中国已经
有雅培(Abbott)和罗奇(Roach)系统。

interdetect

回复 StephenW 的帖子

我想这个不会需要太长的时间，医疗仪器注册还是比较宽松的，但是西门子要拿出绝对优势的数据去跟罗氏和雅培竞争。

donghufen

嘿嘿，西门子我最了解了，这个注册证，前年跟我们说去年能拿到，去年说今年，今年说年底，哈哈

interdetect

回复 donghufen 的帖子

那估计是他们技术还不成熟

StephenW

下面是从意大利,比萨(Pisa)我们的好朋友Stef2011 (Stefano)的关于罗氏(Abbott)和
雅培(Roche)乙肝表面抗原定量检测的答案:

[Stephen]纠正我，如果我错了。我认为雅培系统是完全自动的，所以即使稀释是必需的，它会用机器做了？
Correct me if I am wrong. I thought the Abbott system is completely automatic, so even if dilution is required, it will be done by machine?

[Stef2011]不是. 雅培在小范围 0.1-250iu/毫升，当然没慢性乙肝患者人低如250iu/ml
乙肝表面抗原，一旦100-300iu/ml接近清除.
在比萨(Pisa, Italy)研究员告诉我，技术人员可以用管道的时候
犯错，因此HBsAg的水平可以有所不同，变化约500iu/ml.
No. Abbott has a small range 0,1-250iu/ml and of course no cronic carrier has such low hbsag as 250iu/ml, once 100-300iu/ml is reached clearance is close.
the researcher in pisa told me that technicians can do mistakes with the pipe sometimes so the hbsag level can vary of about 500iu/ml

[StephenW]稀释必须由人做吗？
Or the dilution must be done by human?

[Stef2011]稀释必须由人做. 事实上，许多实验室都这么懒，仅仅报告效果为“>250iu/ml" 因为他们不想管，并采取愚蠢的稀释。我觉得现在有些技术员
是如此无知使用自动的检测，有时我们知道的比他们更多。
Dilution is required by human, in fact many labs are so lazy to give result as >250iu/ml just because they don't want to take the pipe and make the stupid dilution.I  think nowadays some techs are so ignorant using automatic assays that sometimes we know more than them.

[StephenW]罗氏的系统，它是全自动的吗？
The Roche's system, is it automatic?

[Stef2011]是的，范围优越，0-52000iu/ml, 没有稀释.
yes and the range is superior getting to 52000iu/ml with no dilution

[StephenW]你知道新的西门子系统？
Do you know anything the new Siemen system?

[Stef2011]在我镇医院使用它，因为它是乙肝表面抗原变异覆盖最好的，他们收集捐献的血液，所以因为我觉得他们使用这个新的西门子系统。
the hospital in my town took it because it is the best as coverage of hbsag mutants, they collect donated blood so i think they changed architect because of this.

Thank you, Stef2011.