NIBSC code 90/690，varicella-zoster antibodies，标准物质证书电子版下载
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CE Marked Material British Working Standard for varicella-zoster antibodies NIBSC code: 90/690 Instructions for use (Version 8.0, Dated 11/05/2020)
This material is a self certified IVD and complies with the requirements of the “EU in vitro diagnostic medical device directive 98/79/EC”.
1. INTENDED USE
This product is CE marked for use as an IVD within the UK, EU member states and EEA countries. In all other territories this product can be used for research purposes only.
This material has been established as the British Standard for varicella-zoster antibody. It contains recalcified human plasma and some users may wish to use this material in preference to the International Standard which is human immunoglobulin.
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.
The preparation contains material of human origin, and the final product and the source materials from which it is derived have been tested and found negative for HBsAg, anti-HIV 1, anti-HIV 2 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
This material has been assigned a unitage of 4 International Units per ampoule following an Collaborative Study to calibrate it against the International standard.
4. CONTENTS
Country of origin of biological material: United Kingdom.
Each ampoule contains a freeze-dried residue comprising, under an atmosphere of nitrogen:
human plasma, recalcified by the addition of calcium chloride, magnesium chloride and kaolin, containing antibodies to varicella-zoster antibodies.
5. STORAGE
Unopened ampoules should be stored at -20°C or below.
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
Dissolve the total contents of the ampoule with 1.0ml of sterile distilled water. Ensure that the entire freeze dried residue is dissolved in this solution.
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.
The British Standard for anti-VZ was included in assays in which batches for varicella immune globulin were assayed against the International Standard during 2005. The results demonstrated that there has been no loss of potency since the initial collaborative study in 1990.
Reconstituted material:Aliquots of the both the IS and 90/690 were stored frozen after reconstitution. These aliquots were thawed and used on one occasion so that they have undergone only a single freeze-thaw cycle. The results of assays of such aliquots against freshly reconstituted IS indicate that there is no loss of potency when aliquots are subjected to a single freeze-thaw cycle.
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