脊髓灰质炎病毒1型(沙宾)的MAPREC分析(第一国际标准)
【编号】:NIBSC00/418 【名称】:脊髓灰质炎病毒1型(沙宾)的MAPREC分析(第一国际标准) 【规格】:个 【价格】:2600元 脊髓灰质炎病毒1型(沙宾)的MAPREC分析(第一国际标准)
编号:NIBSC00/418
英文:MAPREC assay of poliovirus type 1 (Sabin) (1st International Standard)
标准类型:国际参考制剂
规格:1个
Customer Notes 00/410 - MAPREC assay of poliovirus type 1 (Sabin).100% 480-A, 525-C DNA(1st International Reference Preparation) 00/416 - MAPREC assay of poliovirus type 1 (Sabin) Low Mutant Virus Reference(1st International Reference Preparation) 00/422 - MAPRECassay of poliovirus type 1 (Sabin) High Mutant Virus Reference(1st International Reference Preparation)
描述:1. INTENDED USE
This control DNA for the MAPREC assay of polio virus type 1 (Sabin) is
intended to be used as a DNA reference sample for the assay.
2. CAUTION
This preparation is not for administration to humans or animals in
the human food chain.
The material is not of human or bovine origin.
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
Preparation 00/418 is assigned a nominal value of 2.0% 480-A, 525-C
based on the results of a WHO collaborative Study.
4. CONTENTS
Country of origin of biological material: USA.
Each DIN 58-377 ampoule contains the freeze-dried residue of cloned
DNA that spans nucleotides 445-561 of type 1 poliovirus (Sabin) RNA.
The DNA was prepared at a nominal concentration of 0.01µg/ml in TE
buffer pH7.5 (10mM Tris-HCl and 1mM EDTA) and 0.1% w/v lactose was
added as a bulking agent prior to freeze-drying.
5. STORAGE
Unopened ampoules should be stored at -20°C or below.
Rehydrate preparation 00/418 in 0.1ml of distilled water. Aliquot the
rehydrated material in 10µl volumes and store at -70°C.
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
No attempt should be made to weigh out any portion of the freeze-dried
material prior to reconstitution
A Standard Operating Procedure for the MAPREC assay is available
from; Chief, Biologicals, World Health Organization. This procedure
requires that an aliquot of 00/418 is tested in each MAPREC assay in
duplicate and used to validate the test.
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.
NIBSC follows the policy of WHO with respect to its reference
materials.
9. REFERENCES
a) WHO (2002) WHO Technical Report Series, 904, 31-91.
b) European Pharmacopoeia, 6th Edition (2009) Vaccines for human use,
Poliomyelitis vaccine oral 04/2008:0215.
10. ACKNOWLEDGEMENTS
We acknowledge the help of the participants of the WHO collaborative study
to evaluate the Poliovirus type1 MAPREC assay.
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