脊髓灰質炎病毒1型（沙賓）的MAPREC分析（第一國際標準）

??【編號】：NIBSC00/418

??【名稱】：脊髓灰質炎病毒1型（沙賓）的MAPREC分析（第一國際標準）

??【規格】：個

??【價格】：2600元

　　脊髓灰質炎病毒1型（沙賓）的MAPREC分析（第一國際標準）

　　編號：NIBSC00/418

　　英文：MAPREC assay of poliovirus type 1 (Sabin) (1st International Standard)

　　標準類型：國際參考制劑

　　規格：1個

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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