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Glomerular Filtration Rate (FIT-GFR) Test( 肾小球滤过率(FIT - GFR)测试)

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发表于 2011-12-4 21:02:41 | 显示全部楼层 |阅读模式
                                                              

Glomerular Filtration Rate (FIT-GFR)



  肾小球滤过率(FIT - GFR)测试



Technical Information
Drug safety has always played a key role in drug development.  Unfortunately, drug toxicity studies often omit careful assessment of kidney function as indicated by recent publications.
Accurate measurements of kidney function using a measured glomerular filtration rate (GFR) test provides necessary and reliable information, while biomarker-based estimates are often misleading.  On May 2010, the FDA published a draft recommending that the drug development process should include a "measure" GFR.1
Based on functional immunoassay technology (FIT), BioPAL has developed immunoassay kits to measure the renal clearance of ideal filtration markers in order to obtain an accurate GFR measurement.  We offer four different kits - Inulin (the gold standard), Iohexol, Gd-DTPA, and Gd-DOTA.
1) A recommendation from the conference is the in drug development, GFR should be measured directly with an inert tracer (e.g. inulin, iohexol, iothalamate, etc.) to determine pharmacokinetic or pharmacodynamic alterations due to kidney dysfunction. FDA KDIGO. Released draft.  Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling. Docket Number FDA-2010-D-0133 May 16, 2010.
FOR RESEARCH USE ONLY.
NOT FOR USE IN DIAGNOSTIC PROCEDURES.

Published Data
Download PDF files of abstracts and posters.
Clinical Research:  Poster [PDF]   -   Paper [PDF]
Veterinary Research:  Abstract [PDF]   -   Paper [PDF]

GFR in Mice:  Abstract [PDF]

The Product
FIT-GFR Test Kits (Patents Pending)
BioPAL offers FIT-GFR kits that support either Inulin, Iohexol, Gd-DTPA or Gd-DOTA as the filtration marker.  E-mail your questions to the customer service [email=cs@BioPAL.com?subject=FIT-GFR]mailbox[/email].
  • FIT-GFR Test Kit for Inulin
    BioPAL's FIT-GFR test kit contains inulin concentrate, rabbit inulin antiserum, goat anti-rabbit IgG-HRP, HRP substrate and stop reagents, an inulin 96 well coated plate, two plate sealer, inulin kit manual and documentation.  Ready-to-use inulin injectate is also available.
    Download a PDF price list.
    Download a PDF kit manual.
    Download a PDF kit worksheet and checklist.
    Download a PDF MSDS.

    BioPAL's inulin immunoassay kits provide a superior analytical method to measure inulin for GFR and nutritional research studies.  This inulin test uses immunoassay to overcome all the major limitations associated with current analytical technology to measure inulin.  The kit provides a sensitive assay that exceeds other methods to measure inulin and can detect inulin at a concentration of 10 ng/ml.

    CLINICAL-GRADE INULIN:  At this time, BioPAL only provides non-clinical grade inulin for preclinical research ONLY.  For investigators that would be interested in clinical-grade inulin to support their clinical research, please download and submit our survey.  After completing the survey please FAX (508-770-1191) or e-mail (cs@BioPAL.com) the form to BioPAL.  Download a Survey Form.

    SINISTRIN (Inutest®):  BioPAL's FIT-GFR (Inulin) kit is compatible with Fresenius's sinistrin, which is an inulin-like compound and is highly soluble in water.  Sinistrin is marketed under the brand-name Inutest®.  You should contact your Fresenius representative for availability.  Download a Comparison Curve.
  • FIT-GFR Test Kit for Iohexol  New!
    BioPAL's FIT-GFR test kit contains iohexol concentrate, rabbit iohexol antiserum, goat anti-rabbit IgG-HRP, HRP substrate and stop reagents, an iohexol 96 well coated plate, two plate sealer, iohexol kit manual and documentation.
    Download a PDF price list.
    Download a PDF kit manual.
    Download a PDF kit worksheet and checklist.
    Download a PDF MSDS.

    Download a PDF Protocol Guide.
  • FIT-GFR Test Kit for Gd-DTPA
    BioPAL's FIT-GFR test kit contains Gd-DTPA concentrate, rabbit Gd-DTPA antiserum, HRP-Gd-DTPA conjugate, HRP substrate and stop reagents, a goat anti-rabbit IgG coated 96 well plate, a plate sealer, Gd-DTPA kit manual and documentation.
    Download a PDF price list.
    Download a PDF kit manual.
    Download a PDF MSDS.

    Download a PDF Protocol Guide.
  • FIT-GFR Test Kit for Gd-DOTA
    BioPAL's FIT-GFR test kit contains Gd-DOTA concentrate, rabbit Gd-DOTA antiserum, HRP-Gd-DOTA conjugate, HRP substrate and stop reagents, a goat anti-rabbit IgG coated 96 well plate, a plate sealer, Gd-DOTA kit manual and documentation.
    Download a PDF price list.
    Download a PDF kit manual.
    Download a PDF MSDS.
The Laboratory Service
BioPAL offers laboratory services for veterinarians who need to run a measured GFR test on canine or feline patients, but do not have the capability to perform the immunoassay in-house.


技术信息
药品安全一直在药物开发中起到了关键作用。不幸的是,药物的毒性研究,往往忽略仔细评估最近的出版物中表示肾功能。
肾功能的精确测量,测量肾小球滤过率(GFR)测试提供了必要的和可靠的信息,而基于生物标志物的估计往往是误导。 2010年5月,美国食品药品管理局发表了一份草案,建议在药物开发过程中应包括一个“措施”GFR.1
基于功能的免疫分析技术(散客™),BioPAL免疫检测试剂盒来衡量理想的过滤标记的肾清除,以获得准确的GFR测量。我们提供四种不同的试剂盒 - 菊粉(金标准),碘海醇,钆喷酸葡胺,钆DOTA。
1)会议的建议是在药物开发,GFR应直接测量与惰性示踪剂(如菊粉,碘海醇iothalamate,等),以确定因肾功能不全的药代动力学或药效的改变。 FDA的KDIGO。发布草案。行业指南:肾功能受损患者的药代动力学 - 研究设计,数据分析,计量和标签的影响。文案号FDA - 2010 - D - 0133,2010年5月16日。
仅供研究使用。
不能在诊断过程中使用。
公布的数据
下载PDF文件的摘要和海报。
临床研究:Poster [PDF]   -   Paper [PDF]
兽医研究:Abstract [PDF]   -   Paper [PDF]
肾小球滤过率在小鼠体内的摘要Abstract [PDF]
该产品
适合GFR检测试剂盒(专利申请中)
BioPAL提供支持要么菊粉,碘海醇,钆喷酸葡胺或GD - DOTA的过滤标记的散客GFR包。电子邮件您的问题,客户服务邮箱。
散客GFR检测试剂盒为菊粉
BioPAL的FIT - GFR检测试剂盒含有菊粉集中菊糖抗血清,兔,羊抗兔IgG - HRP,HRP的底物和停止试剂,菊粉96,涂层板,两个板盖,菊粉试剂盒说明书和文档。准备使用的菊粉injectate也可。
Download a PDF price list.
Download a PDF kit manual.
Download a PDF kit worksheet and checklist.
Download a PDF MSDS.

BioPAL的菊粉免疫检测试剂盒提供了优越的分析方法来衡量GFR和营养研究菊粉的。这菊粉试验采用免疫法,以克服目前的分析技术来衡量菊粉与所有相关的主要限制。该套件提供了一个敏感的检测,超过其他的方法来衡量菊粉和10毫微克/毫升的浓度可以检测菊粉。

临床级菊粉:此时,BioPAL仅提供非临床级菊粉仅用于临床前研究。对于将在临床级菊粉感兴趣的调查,支持他们的临床研究,请下载并提交我们的调查。调查完成后,请传真(508-770-1191)或e - mail(cs@BioPAL.com)BioPAL形式。Download a Survey Form.

SINISTRIN(Inutest ®):BioPAL的FIT肾小球滤过率(菊粉)试剂盒与费森尤斯的sinistrin,这是一种菊粉类似的化合物,是非常易溶于水兼容。 Sinistrin销售名牌Inutest ®。您应该联系您的可用性费森尤斯代表。Download a Comparison Curve.

散客GFR碘海醇新的测试工具包!
BioPAL的FIT - GFR检测试剂盒中​​包含的碘海醇集中碘海醇抗血清,兔,羊抗兔IgG - HRP,HRP基板和停止试剂,碘海醇96以及涂层板,两个板盖,碘海醇试剂盒说明书和文档。
Download a PDF price list.
Download a PDF kit manual.
Download a PDF kit worksheet and checklist.
Download a PDF MSDS.

Download a PDF Protocol Guide.


散客GFR检测试剂盒的Gd - DTPA
BioPAL的散客,肾小球滤过率的测试套件的Gd - DTPA集中,兔Gd - DTPA增强抗血清,HRP -钆- DTPA的共轭HRP的底物和停止试剂,一个山羊抗兔IgG的涂层96井板,一个板封口机,Gd - DTPA增强套件手册和文件。
Download a PDF price list.
Download a PDF kit manual.
Download a PDF MSDS.

Download a PDF Protocol Guide.


散客GFR检测试剂盒的Gd - DOTA
BioPAL的散客,肾小球滤过率的测试套件钆- DOTA的集中,兔钆- DOTA的抗血清,HRP -钆- DOTA的共轭HRP的底物和停止试剂,一个山羊抗兔IgG的涂层96井板,一个板封口机,钆,DOTA的试剂盒手册和文件。
Download a PDF price list.
Download a PDF kit manual.
Download a PDF MSDS.



实验室服务
BioPAL提供实验室服务,为那些需要运行一个衡量GFR犬或猫患者测试的兽医,但没有能力执行内部的免疫分析

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