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RACTIVITY | Human |
SENSITIVITY | <1.5 mIU/mL |
ASSAY RANGE | 1.5-200 mIU/mL |
REAGENTS PROVIDED | MICROTITER PLATECONJUGATESTANDARD – 200 mIU/mLSTANDARD – 100 mIU/mLSTANDARD – 50 mIU/mLSTANDARD – 25 mIU/mLSTANDARD – 5mIU/mLSTANDARD – 0 mIU/mLSUBSTRATE ASUBSTRATE BSTOP SOLUTION |
INTENDED USE
This Human FSH ELISA Kit is to be used for the in vitro quantitative determination of human follicle stimulating hormone (FSH) concentrations in serum. This kit is intended FOR LABORATORY RESEARCH USE ONLY and is not for use in diagnostic or therapeutic procedures.
INTRODUCTION
Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH) are intimately involved in the control of the growth and reproductive activities of the gonadal tissues, which synthesize and secrete male and female sex hormones. The levels of circulatingFSHand LH are controlled by these sex hormones through a negative feedback relationship.
FSHis a glycoprotein secreted by the basophil cells of the anterior pituitary. Gonadotropin-releasing hormone (GnRH), produced in the hypothalamus, controls the release ofFSHfrom the anterior pituitary. Like other glycoproteins, such as LH,TSH, and HCG,FSHconsists of subunits designated as alpha and beta. Hormones of this type have alpha subunits that are very similar in structure; therefore the biological and immunological properties of each are dependent on the unique beta subunit.
In the female,FSHstimulates the growth and maturation of ovarian follicles by acting directly on the receptors located on the granulosa cells; follicular steroidogenesis is promoted and LH production is stimulated. The LH produced then binds to the theca cells and stimulates steroidogenesis. Increased intraovarian estradiol production occurs as follicular maturation advances, thereupon stimulating increasedFSHreceptor activity andFSHfollicular binding.FSH, LH and estradiol are therefore intimately related in supporting ovarian recruitment and maturation in women.FSHlevels are elevated after menopause, castration, and in premature ovarian failure. The levels ofFSHmay be normalized through the administration of estrogens, which demonstrate a negative feedback mechanism. Abnormal relationships betweenFSHand LH and betweenFSHand estrogen have been linked to anorexia nervosa and polycystic ovarian disease. Although there are significant exceptions, ovarian failure is indicated when randomFSHconcentrations exceed 40 mIU/mL.
The growth of the seminiferous tubules and maintenance of spermatogenesis in men are regulated by FSH. However, androgens, unlike estrogens, do not lower FSH levels, therefore demonstrating a feedback relationship only with serum LH. For reasons not fully understood, azospermic and oligospermic males usually have elevated FSH levels. Tumors of the testes generally depress serum FSH concentrations, but levels of LH are elevated, as determined by radioimmunoassay. It has been postulated that the apparent LH increase may be caused by cross-reactivity with hCG-like substances secreted by tumors of the testes. High levels of FSH in men may be found in primary testicular failure and Klinefelter syndrome. Elevated concentrations are also present in cases of starvation, renal failure, hyperthyroidism, and cirrhosis.
PRINCIPLE OF THE ASSAY
This FSH enzyme linked immunosorbent assay (ELISA) applies a technique called a quantitative sandwich immunoassay. The microtiter plate provided in this kit has been pre-coated with a monoclonal antibody specific forFSH. Standards or samples are then added to the microtiter plate wells andFSHif present, will bind to the antibody pre-coated on the wells. In order to quantitate the amount ofFSHpresent in the sample, a standardized preparation of horseradish peroxidase (HRP) conjugated monoclonal antibody specific forFSHis added to each well to “sandwich” theFSHimmobilized on the plate. The microtiter plate undergoes incubation, and then the wells are thoroughly washed to remove all unbound components. Next, aTMB (3,3",5,5" Tetramethyl-benzidene) substrate solution is added to each well. This enzyme (HRP) and substrate are allowed to react over a short incubation period. Only those wells that containFSHand enzyme-conjugated antibody will exhibit a change in colour. The enzyme-substrate reaction is terminated by the addition of a sulphuric acid solution and the colour change is measured spectrophotometrically at a wavelength of 450 nm.
In order to measure the concentration of FSH in the sample this Human FSH ELISA Kit includes a set of calibration standards (6 standards). The calibration standards are assayed at the same time as the samples and allow the operator to produce a standard curve of Optical Density (O.D.) versus FSH concentration (mIU/mL). The concentration of FSH in the samples is then determined by comparing the O.D. of the samples to the standard curve.
CITATIONS
1. Q Xu et al. Br J Cancer. Isolation of tumour stem-like cells from benign tumours. Jul 21, 2009; 101(2): 303–311.
2.Akyol S, Cınar SA, Purisa S, Aydinli K. Relationship between lymphocytes, IL2 and the hormones E2, LH, PRG and FSH in menopausal and postmenopausal women. Am J Reprod Immunol. 2011 Oct;66(4):304-9.
Additional
Additional Information
| Product Specificity | Human FSH ELISA Kit |
|---|---|
| Application | Refer to Insert |
| Size | 96 wells |
ebiomall.com
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对照品系指用于鉴别、检查、含量测定和校正检定仪器性能的标准物质，而标准品系指用于生物检定、抗生素或生物药品中含量或效价测定的标准物质，以效价单位(U)表示。
还是感觉不甚明了，是否标准品只用于生物方面？是否化学方面只能称对照品？标准品有什么要求？对照品有什么要求？
From:http://www.cdda.gov.cn/index/zcfg_detail.asp?ID=62a
国家药品标准品、对照品系指国家药品标准中用于鉴别、检查、含量测定、杂质和有关物质检查等标准物质，它是国家药品标准不可分割的组成部分。国家药品标准物质是国家药品标准的物质基础，它是用来检查药品质量的一种特殊的专用量具；是测量药品质量的基准；也是做为校正测试仪器与方法的物质标准；在药品检验中，它是确定药品真伪优劣的对照，是控制药品质量必不可少的工具。
目前，中国药品生物制品检定所已能提供各类国家标准物质1242种，其中中药化学对照品288种，对照药材400种，两者占总数的一半以上，
from:http://www.chp.org.cn/2005gs/swfl/swfl.htm
国家标准品及生物参考品系指用于鉴别、检查含量或效价测定的标准物质，其制备与标定应符合“生物制品国家标准物质制备和标定规程”要求，并由国务院药品监督管理部门指定的机构分发。企业工作标准品或参考品必须经国家标准品或参考品标化后方能使用。
对照品系指用于生物制品理化等方面测定的特定物质，由生产单位采用与制品生产工艺相同的方法制备。对照品应尽可能与制品原液配方一致，稳定性较差的，可加不含对测定有干扰物质的适宜的稳定剂。对照品由国家药品检定机构审查认可，其标准应不低于制品的质量标准。
From:http://www.pharm.sdu.edu.cn/peiyang/jiaoan/yaowufenxihx.doc
（3）标准品、对照品：是指用于鉴别、检查、含量测定的标准物质，均由国务院药品监督管理部门指定的单位制备、标定和供应。标准品系指用于生物测定、抗生素或生化药品中含量或效价测定的标准物质，一国际标准品进行标定；对照品出另有规定外，按干燥进行计算后使用。
标准品和对照品均附有使用说明书，质量要求，有效期和装量等。
From:http://www.chp.org.cn/2005gs/swfl/swbz.htm
1定义
生物制品标准物质系指用于生物制品效价、活性或含量测定的或其特性鉴别、检查的生物标准品或生物参考物质。
2标准物质的种类
生物制品标准物质分为二类。
国家生物标准品系指用国际标准品标定的，或我国自行研制的(尚无国际生物标准品者)用于定量测定某一制品效价或毒性的标准物质，其生物活性以国际单位（IU）或以单位（U）表示。
国家生物参考品系指用国际参考品标定的，或我国自行研制的(尚无国际参考品者)用于微生物(或其产物)的定性鉴定或疾病诊断的生物试剂、生物材料或特异性抗血清；或指用于定量检测某些制品的生物效价的参考物质，如用于麻疹活疫苗滴度或类毒素絮状单位测定的参考品，其效价以特定活性单位表示，不以（IU）表示。
From:http://www.proteomics.com.cn/msl/papers/Notice1.html
1 对照品与标准品概念不清
对照品与标准品是2个不同的概念，中国药典凡例中已有明确的定义：对照品系指用于鉴别、检查、含量测定和校正检定仪器性能的标准物质，而标准品系指用于生物检定、抗生素或生物药品中含量或效价测定的标准物质，以效价单位(U)表示。文献中常将2种概念混淆，认为对照品就是标准品，是1种物质2种提法而已［1，2］，造成错误的原因，可能是有的药品既有对照品，又有标准品。例如，当用微生物法测定头孢克罗效价时，用头孢克罗标准品，用HPLC或UV法测定时，则用对照品；非那西丁当用作熔点校准物质时，用熔点标准品，测定含量时，用对照品。即使是同一种物质的标准品和对照品，它们的规格、标定方法以及用途都可能是不同的。
2 对照品或标准品混用
对照品或标准品混用，即将对照品或标准品用于不是其标定方法的含量测定，是药品检验中经常出现但未引起重视的一个问题［3］。尽管同一批对照品不同标定方法的含量有很好的相关性，但并不完全相同，有时差别会很大。如英国Glaxo公司提供的头孢呋肟酯对照品，HPLC标定为96.9%，供含量测定用；UV为98.8%，供溶出度测定。虽然中国药典凡例明确规定卫生部所发对照品仅用于正文中所规定的分析方法。但由于：(1)卫生部提供的对照品使用说明书不够详尽，大多无对照品质量要求及标定方法；(2)对对照品或标准品的正确使用缺乏认识；(3)日常科研中极难找到相应的对照品；(4)中国药典正文中也常存在对照品混用的问题，如常将含量测定用的标准品或对照品用于溶出度检查，而含量测定方法与溶出度分析方法又不同，故极易引起混用。
Blood lipid Standards
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提醒大家几点：中检所和各地药检所售的都是药典或国家标准中应使用到的标准品和对照品，如果您是建立新药或某些新方法所用到的对照品，他们哪儿一般不会有，此时多为各研究单位自行制备对照品。
在您打电话询问时可以登入中检所的网站在搜索模块中下拉标准物质搜索，看看中检所是否已有此种物质。
若为地方升国标的标准中用到的对照品，中检所一般较少有，最好的方法是找到原始地方标准所在地，与该地的省所联系购买。
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中检所：010－6705152467017755转219/239
北京所：010－66125040
:)河北所：0311－6673174
:)四川所：028－87525503
:)广东所：020-81847931
http://www.gdyjs.org.cn/wxyd/jj.htm
海南所：0898－66222646、66219706、66219772、66218770
http://www.hnyjs.org
:)江苏所：025-83203019852913198663952286631803
http://www.jsidc.org/zxfw/cpzs1.asp
浙江所：0571-8645317186457786
中药标准品：
http://xiehegroup.cn/public_html/page/zjxh_xhqx_zykfzxml.htm
http://www.cctyi.com
http://www.chem911.com/htmls/urls/standard.asp
进口试剂：
http://www.jkchemical.com/home.htm（该公司可以提供USP/BP/JP的对照品）
http://218.30.124.40/
将不定期更新
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广东药检所2003年的对照品一览表，可下载查询：
呵呵，kunben兄我修改一下标题！看看大家效果！
2003年标准品一览表.zip(59.72k)
