WHO International Standard
HUMAN C-REACTIVE PROTEIN  1st International Standard
NIBSC code: 85/506 Instructions for use
(Version 3.0, Dated 19/03/2008)
1.    INTENDED USE
Calibrant for C-reactive protein assays
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 wit
h 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
49 milli-International Units (IU) per ampoule.
4.    CONTENTS
Country of origin of biological material: United Kingdom.
Each ampoule contains the residue after freeze drying of 0.5ml of a solution that contained:
50 µg Human C-reactive protein 0.5ml pooled normal human serum
The material has not been sterilized and the ampoules contain no bacteriostat.
5.    STORAGE
Store at -20ºC or below
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 freeze-dried material prior to reconstitution.
For all practical purposes each ampoule contains the same amount of the same materials.  Dissolve the total contents in a known amount of suitable buffer solution with carrier protein (free of peptidase), where extensive dilution is required, to minimise loss by surface adsorption.
For economy of use it is recommended that the solution be subdivided into several small containers, which are frozen rapidly to below –40ºC and then stored below –40ºC in the dark.  Repeated freezing and thawing should be avoided.
8.    STABILITY
Reference materials are held at NIBSC within assured, temperature-controlled storage facilities.  Reference Materials should be stored on receipt as indicated on the label.
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.
9.    REFERENCES
WHO Expert Committee on Biological Standardization (1992), 42nd Report.  WHO Technical Report Series, 760, p21, 1987.
10.    ACKNOWLEDGEMENTS Not Applicable
11.    FURTHER INFORMATION
Further information can be obtained as follows; This material: WHO Biological Standards:
www.who.int/biologicals/en/
JCTLM Higher order reference materials: /en/committees/jc/jctlm/ Derivation of International Units:
/standardisation/international_standards.aspx Ordering standards from NIBSC:
/products/ordering.aspx NIBSC Terms & Conditions:
/terms_and_conditions.aspx
12.    CUSTOMER FEEDBACK
Customers are encouraged to provide feedback on the suitability or use of the material provided or other aspects of our service. Please send any comments to
13.    CITATION
In all publications, including data sheets, in which this material is referenced, it is important that the preparation's title, its status, the NIBSC code number, and the name and address of NIBSC are cited and cited correctly.
14.    MATERIAL SAFETY SHEET
Classification in accordance with Directive 2000/54/EC, Regulation (EC)
15.    LIABILITY AND LOSS
In the event that this document is translated into another language, the English language version shall prevail in the event of any inconsistencies between the documents.
Unless expressly stated otherwise by NIB SC, NIBSC’s Standard Terms and Conditions for the Supply of Materials (available at /About_Us/Terms_and_Conditions.aspx or upon request
by the Recipient) (“Conditions”) apply to the exclusion of all other terms and are hereby incorporated into this document by reference. The Recipient's attention is drawn in particular to the provisions of clause 11 of the Conditions.
17.    CERTIFICATE OF ANALYSIS
NIBSC does not provide a Certificate of Analysis for WHO Biological Reference Materials because they are internationally recognised primary reference materials fully described in the instructions for use.  The reference materials are established according to the WHO Recommendations for the preparation, characterization and establishment of international and other biological reference standards www.who.int/bloodproducts/publications/TRS932Annex2_Inter_bi olefstandardsrev2004.pdf (revised 2004). They are officially endorsed by the WHO Expert Committee on Biological Standardization (ECBS) based on the report of the international collaborative study which established their suitability for the intended use.
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