血漿纖維蛋白原(牛血纖維蛋白原)

??【編號】：NIBSC09/264

??【名稱】：血漿纖維蛋白原(牛血纖維蛋白原)

??【規格】：個

??【價格】：2400元

　　血漿纖維蛋白原(牛血纖維蛋白原)

　　編號：NIBSC09/264

　　英文：Fibrinogen Plasma (D)(3rd International Standard)

　　標準類型：國際標準

　　關鍵字詞：纖維蛋白原血漿止血凝結條款測定止血凝塊WHO國際標準可凝塊蛋白纖維蛋白封閉劑3rd IS CLOTr纖維蛋白原缺乏癥纖維蛋白Fg Fn

　　相關產品：98/614，

　　客戶須知：1.本《 WHO國際標準》代替了先前的《 WHO第二國際血漿纖維蛋白原》（98/612）。2.本國際標準主要使用克勞斯測定法進行了校準。

　　最小用量：1個

1. INTENDED USE

The WHO 3

rd International Standard for Fibrinogen Plasma, consists of

glass ampoules, coded 09/264, containing 1ml aliquots of a freeze-dried

solvent-detergent treated pooled normal human plasma. This preparation

was established by the Expert Committee on Biological Standardization of

the World Health Organization in October 2011 and details of the

preparation and value assignment are available in document

WHO/BS/2011.2168. This standard is intended to be used in the

measurement of fibrinogen in plasma and is primariliy intended for

calibration of secondary and/or in-house working standards of fibrinogen

plasma.

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 WHO 3

rd International Standard was calibrated in an international

collaborative study involving 21 laboratories in 11 countries. A potency of

2.7 mg per ampoule

has been assigned. This figure is based on comparison with the 2

International Standard for Fibrinogen Plasma, using primarily Clauss

assays.

4. CONTENTS

Country of origin of biological material: United Kingdom

The WHO 3rd International Standard for Fibrinogen Plasma, consists of

aliquots of a freeze-dried solvent-detergent treated pooled normal

human plasma and was prepared at the National Institute for Biological

Standards and Control (NIBSC) in January 2010.

After thawing of 50 units (10,000 ml) of the product, this material was

pooled and kept on ice prior to being filled and freeze-dried in sealed

glass ampoules at NIBSC, under conditions required for International

Standards1

. One ml of this material was dispensed into each of

approximately 10,000 ampoules. The mean filling weight was 1.0080 g

(range 1.0020 g to 1.0150 g) and the coefficient of variation (CV) was

0.18% based on 396 check-weight samples. Mean residual moisture

after freeze-drying was 0.34% (CV 24.8%, n=12) and mean oxygen

headspace was 0.29% (CV 32.2%, n=12).

5. STORAGE

Unopened ampoules should be stored in the dark at -20ºC. After

reconstitution, any unused material must be discarded, not frozen for later

use.

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

The total contents of the ampoule should be reconstituted at room

temperature with 1 ml distilled water, dissolved by gentle swirling to avoid

froth and transferred immediately to a suitable plastic tube. No attempt

should be made to weigh out any portion of the freeze-dried material.

8. STABILITY

Reference materials are held at NIBSC within assured, temperaturecontrolled

storage facilities. Reference Materials should be stored on

receipt as indicated on the label.

In common with previous WHO Plasma Standards for blood coagulation

factors, it is recommended that the standard is transferred, after

reconstitution, to a plastic tube and if stored on melting ice, the standard

should be used within 3 hours of reconstitution.

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

9. REFERENCES

1. Campbell P J. Procedures used for the production of biological standards

and reference preparations. J Biol Standardization 1974; 2: 259-67.

10. ACKNOWLEDGEMENTS

The contributions of all the participants in the study are gratefully

acknowledged. We are grateful to our colleagues in the Standards

Processing Division and Process Development Section, NIBSC, for

ampouling and processing the candidate and trial preparations and for

the dispatch of collaborative study samples to participants. We are

grateful to Kedrion S.p.A. (Italy) and Octapharma (Austria) for their kind

donation of materials for the study. We further like to thank the

ISTH/SSC Fibrinogen and Factor XIII Subcommittee for their support.

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