WHO International Standard Ferritin, human, recombinant
NIBSC code: 94/572 Instructions for u
(Version 3.0, Dated 04/04/2008)
1. INTENDED USE
The standard 94/572 is for u in immunoassays for human rum ferritin.
The recombinant ferritin preparation, 94/572, was evaluated by 18 laboratories in 9 countries for its suitability as an International Standard (IS; reference 1). The preparation was assayed in a wide range of in-hou and commercial immunoassays against the 2nd IS for ferritin, spleen (80/578). The recombinant ferritin was immunologically similar to the 2nd IS in the majority of assays, and demonstrated adequate stability in accelerated degradation studies. On the basis of the results, and
with the overall agreement of the participants of the collaborative study, the World Health Organization (WHO) Expert Committee on Biological Standardization established 94/572 as the 3rd IS for ferritin, recombinant, with an ASSIGNED CONTENT OF 6.3 MICROGRAMS/AMPOULE.
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Uncertainty: the uncertainty may be considered to be the variance of the ampoule content and was determined to be +/- 0.345%.
2. CAUTION
This preparation is not for administration to humans .
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 ud 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 exercid in opening ampoules or vials, to avoid cuts.
3. UNITAGE
Each ampoule contains 6.3 micrograms ferritin
4. CONTENTS
Country of origin of biological material: United Kingdom.
Recombinant human ferritin was expresd in an E Coli strain transformed with the plasmid pEMBLex2LFT which encodes the full human ferritin L-chain amino acid quence. Details of its production, purification and characterization are described in references 2-4.
The recombinant ferritin was diluted in human cryosupernatant plasma (pooled from individual donations which had been tested and found negative for HBsAg, anti-HIV and anti-HCV; kindly provided by North East Thames Regional Transfusion Centre, Brentwood, Esx, UK) before distribution into ampoules and lyophilization.
5. STORAGEshlong
Store unopened ampoules at or below -20ºC.
6. DIRECTIONS FOR OPENING
DIN ampoules have an …easy -open‟ coloured stress point, where the narrow ampoule stem joins the wider ampoule body.
Tap the ampoule gently to collect the material at the bottom (labeled) end. Ensure that the disposable ampoule safety breaker provided is pushed down on the stem of the ampoule and against the shoulder of the ampoule body. Hold the body of the ampoule in one hand and the disposable ampoule breaker covering the ampoule stem between the thumb and first finger of the other hand. Apply a bending force to open
the ampoule at the coloured stress point, primarily using the hand holding the plastic collar.
Care should be taken to avoid cuts and projectile glass fragments that might enter the eyes, for example, by the u of suitable gloves and an eye shield. Take care that no material is lost from the ampoule and no glass falls into the ampoule. Within the ampoule is dry nitrogen gas at slightly less than atmospheric pressure. A new disposable ampoule breaker is provided with each DIN ampoule.
7. USE OF MATERIAL
No attempt should be made to weigh out any portion of the freeze-dried material prior to reconstitution.
Reconstitute the contents of each ampoule with 1.0 ml distilled water. Store at 4ºC (short term only since the preparation does not contain sodium azide).
THE FERRITIN CONCENTRATION OF THE RECONSTITUTED MATERIAL IS 6.3 MICROGRAMS/ML.
8. 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. Accelerated degradation studies have indicated that this standard is suitably stable, when stored at -20ºC or below, for the assigned values to remain valid until the standard is withdrawn or replaced. The studies have also shown that the standard is suitably stable for shipment at ambient temperature without any effect on the assigned values.
Reference materials are held at NIBSC within assured, temperature-controlled storage facilities. Reference Materials should be stored on receipt as indicated on the label. For information specific to a particular biological standard, contact the Technical Information Officer or, where known, the appropriate NIBSC scientist.
NIBSC follows the policy of WHO with respect to its reference materials.
Urs who have data supporting any deterioration in the characteristics of any reference preparation are encouraged to contact NIBSC.
9. REFERENCES
1. S J Thorpe, D Walker, P Arosio, A Heath, J Cook and M Worwood. Clin Chem (1997) 43:1582-1587.
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2. Levi et al. Biochem J (1992) 288:591-596.
3. Santambrogio et al. J Biol Chem (1993) 268:12744-12748.
4. Levi et al. J Biol Chem (1994) 269:30334-30339.
10. ACKNOWLEDGEMENTS
We thank the participants of the collaborative study to assign unitage.
11. FURTHER INFORMATION
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Further information can be obtained as follows; This material:
enquiries@nibsc.hpa.uk WHO Biological Standards:
Http://www.who.int/biologicals/en/
JCTLM Higher order reference materials: Http://www.bipm/en/committees/jc/jctlm/ Derivation of International Units:lounge是什么意思
www.who.int/biologicals/reference_preparations/en/ Ordering standards from NIBSC:
Http://www.nibsc.ac.uk/products/ordering_information/frequently_asked_questions.aspx
accomplish的用法NIBSC Terms & Conditions:
Http://www.nibsc.ac.uk/terms_and_conditions.aspx
12. CUSTOMER FEEDBACK
Customers are encouraged to provide feedback on the suitability or u of the material provided or other aspects of our rvice. Plea nd any comments to enquiries@nibsc.hpa.uk
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.
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学困生辅导计划15. LIABILITY AND LOSS
Information provided by the Institute is given after the exerci of all reasonable care and skill in its compilation, preparation and issue, but it is provided without liability to the Recipient in its application and u. It is the responsibility of the Recipient to determine the appropriateness of the standards or reference materials supplied by the Institute to the Recipient (“the Goods”) for the propod application and ensure that it has the necessary technical skills to determine that they are appropriate. Results obtained from the Goods are likely to be dependant on conditions of u by the Recipient and the variability of materials beyond the control of the Institute.
All warranties are excluded to the fullest extent permitted by law, including without limitation that the Goods are free from infectious agents or that the supply of Goods will not infringe any rights of any third party.
贵阳六中英语实验学校The Institute shall not be liable to the Recipient for any economic loss whether direct or indirect, which ari in connection with this agreement.
The total liability of the Institute in connection with this agreement, whether for negligence or breach of contract or otherwi, shall in no event exceed 120% of any price paid or payable by the Recipient
for the supply of the Goods.
If any of the Goods supplied by the Institute should prove not to meet their specification when stored and ud correctly (and provided that the Recipient has returned the Goods to the Institute together with written notification of such alleged defect within ven days of the time when the Recipient discovers or ought to have discovered the defect), the Institute shall either replace the Goods or, at its sole option, refund the handling charge provided that performance of either one of the above options shall constitute an entire discharge of the Institute‟s liability under this Condition.
