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抑制素B，人， WHO 參考試劑

??【編號(hào)】：NIBSC96/784

??【產(chǎn)品名稱】：抑制素B，人， WHO 參考試劑

??【規(guī)格】：個(gè)

??【價(jià)格】：2600元

　　抑制素B，人， WHO 參考試劑

　　編號(hào)：NIBSC96/784

　　英文：Inhibin B, Human WHO Reference Reagent

　　標(biāo)準(zhǔn)類型：國(guó)際標(biāo)準(zhǔn)品

　　規(guī)格：1個(gè)

　　描述：

1. INTENDED USE

This consists of a batch of ampoules containing immunoaffinity-purified

natural human inhibin. The preparation contains a mixture of inhibin A,

inhibin B and inhibin a-subunit which, after dilution in a solution containing

Tris (25mM), sodium chloride (0.85% w/v), human serum albumin (0.5%

w/v) and Triton X100 (0.1% v/v) was freeze-dried and secondarily

desiccated and evaluated in an international collaborative study as a

candidate WHO reference reagent for inhibin B.

2. CAUTION

This preparation is not for administration to humans or animals in

the human food chain.

The preparation contains material of human origin, and either the final

product or the source materials, from which it is derived, have been

tested and found negative for HBsAg, anti-HIV and HCV RNA. As with

all materials of biological origin, this preparation should be regarded as

potentially hazardous to health. It should be used and discarded

according to your own laboratory's safety procedures. Such safety

procedures should include the wearing of protective gloves and

avoiding the generation of aerosols. Care should be exercised in

opening ampoules or vials, to avoid cuts.

3. UNITAGE

The assigned unitage is 12 U per ampoule. On the basis of immunoassay

results the nominal mass content is 12 ng per ampoule. These units

should not be assumed to be interconvertible.

Because of possible toxic effects from the formulation, this preparation

may not be suitable for some bioassay systems.

4. CONTENTS

Country of origin of biological material: United Kingdom.

Each ampoule contains the residue after freeze-drying of 1ml of a solution

which contained:

Tris 3.03mg/ml

Human Serum albumin 5mg/ml

Sodium chloride 8.5mg/ml

Triton X100 1mg/ml

Human inhibin -

NB. When received at NIBSC, the preparation contained 6 M guanidine.

If reconstituted in 1 ml, the solution will contain 0.03 M guanidine

(approximately 2.85 mg/ml).

5. STORAGE

Unopened ampoules should be stored at –20ºC

Please note: because of the inherent stability of lyophilized

material, NIBSC may ship these materials at ambient temperature.

6. DIRECTIONS FOR OPENING

DIN ampoules have an 'easy-open' coloured stress point, where the

narrow ampoule stem joins the wider ampoule body. Various types of

ampoule breaker are available commercially. To open the ampoule,

tap the ampoule gently to collect material at the bottom (labelled) end

and follow manufactures instructions provided with the ampoule

breaker.

7. USE OF MATERIAL

For practical purposes each ampoule contains the same quantity of

inhibin B. The entire content of each ampoule should be completely

dissolved in an accurately measured amount of buffer solution. No attempt should be made to weigh out portions of the freeze dried powder.

The use of water to reconstitute ampoule contents is not recommended. The

material has not been sterilized and the ampoules contain no bacteriostat.

8. COLLABORATIVE STUDY AND ASSIGNMENT OF UNITAGE

A preparation of immunoaffinity-purified inhibin B was examined and

compared with local standards in current use in bioassays and

immunoassays in six laboratories in five countries.

The study provided evidence that the preparation would be suitable to serve

as a Reference Reagent for inhibin B since it was shown:

• qualitatively - to have appropriate inhibin biological activity

- to have inhibin B immunoreactivity

• quantitatively - to give a mean estimate of 12.9 ng per ampoule

(95% confidence limits 12.0 - 13.8) by immunoassay

- to be sufficiently stable to serve as a reference reagent

Accordingly, the preparation in ampoules coded 96/784 was established as

the First WHO Reference Reagent for Inhibin B, and assigned a unitage of

12 Units per ampoule by WHO (October, 2000). However because of

possible toxic effects from the formulation, this preparation may not be

suitable for some bioassay systems. On the basis of the immunoassay

results, preparation 96/784 was assigned a nominal mass content of 12 ng

per ampoule. The bioactivity units and the immunoactivity units should not

be assumed to be interconvertible.

9. STABILITY

It is the policy of WHO not to assign an expiry date to their international

reference materials. They remain valid with the assigned potency and

status until withdrawn or amended.

Reference materials are held at NIBSC within assured, temperaturecontrolled

storage facilities. Reference Materials should be stored on

receipt as indicated on the label. For information specific to a particular

biological standard, contact standards@nibsc.ac.uk.

In addition, once reconstituted, diluted or aliquoted, users should

determine the stability of the material according to their own method of

preparation, storage and use.

NIBSC follows the policy of WHO with respect to its reference materials.

Users who have data supporting any deterioration in the characteristics of

any reference preparation are encouraged to contact NIBSC.

10. ACKNOWLEDGEMENTS

Grateful acknowledgements are due to Professor Nigel Groome, Oxford

Brookes University, Oxford, UK for providing the material and Dr P Dawson

and the staff of Standards Division for ampouling the preparation.

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