血清淀粉樣蛋白A。世衛組織國際標準

??【編號】：NIBSC92/680

??【名稱】：血清淀粉樣蛋白A。世衛組織國際標準

??【規格】：個

??【價格】：停產

　　血清淀粉樣蛋白A。世衛組織國際標準

　　編號：NIBSC92/680

　　英文：Serum amyloid A protein. WHO International Standard

　　標準類型：國際標準

　　規格：1個

　　描述：1. INTENDED USE

Calibrant for serum amyloid A assays

2. CAUTION

This preparation is not for administration to humans or animals in

the human food chain.

This preparation contains material of human origin. It has been tested and

found negative for HBsAg and anti-HIV. The preparation gave a

positive antibody test and a positive PCR test for 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

0.15 International Units (IU) per ampoule.

4. CONTENTS

Country of origin of biological material: United Kingdom.

Each ampoule contains the residue after freeze-drying of 1.0ml of a

solution that contained:

156mg/L of purified SAA in normal human serum.

The material has not been sterilised and contains no bacteriostat.

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

Tap the ampoule gently to collect the material at the bottom (labelled)

end. Ensure ampoule is scored all round at the narrow part of the

neck, with a diamond or tungsten carbide tipped glass knife file or

other suitable implement before attempting to open. Place the

ampoule in the ampoule opener, positioning the score at position 'A';

shown in the diagram below. Surround the ampoule with cloth or

layers of tissue paper. Grip the ampoule and holder in the hand and

squeeze at point 'B'. The ampoule will snap open. Take care to avoid

cuts and projectile glass fragments that enter eyes. Take care that no

material is lost from the ampoule and that no glass falls into the

ampoule.

Side view of ampoule opening device containing an ampoule

positioned ready to open. 'A' is the score mark and 'B' the point of

applied pressure.

7. USE OF MATERIAL

No attempt should be made to weigh out any portion of the

materialFor all practical purposes each ampoule contains the same amount of the

same materials. Dissolve the total contents in a known amount of distilled

water and make further dilutions in a suitable buffer solution with carrier

protein (free of peptidase), where extensive dilution is required, to minimise

loss by surface adsorption.

No attempt should be made to weigh out any portion of the freeze-dried

powder.

For economy of use it is recommended that the solution be subdivided into

several small containers, which are frozen rapidly to below –40°C and then

stored below –40°C in the dark. Repeated freeze thawing should be

avoided.

Suitable precautions should be taken in the use and disposal of the ampoule

and its contents.

8. STABILITY

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

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, temperature-controlled storage facilities.

Reference Materials should be stored on receipt as indicated on the

label. 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. Users who have data supporting any

deterioration in the characteristics of any reference preparation are

encouraged to contact NIBSC.

9. REFERENCES

Preparation described in: Wilkins, J., Gallimore, J.R., Tennent, G.A.,

Hawkins, P.N., Limburg, P.C., van Rijswijk, M.H., Moore, E.G., and Pepys,

M.B. (1984) Rapid automated enzyme immunoassay of serum amyloid A.

Clin. Chem. 40:1284-1290.

10. ACKNOWLEDGEMENTS

The SAA contained in this ampoule was provided by Professor M B Pepys,

Immunological Medicine Unit, Department of Medicine, Royal Postgraduate

Medical School, Hammersmith Hospital, Du Cane Road, London W12 ONN.

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