用于脊髓灰質炎1型脊髓灰質炎病毒的MAPREC測定的低突變病毒參考（沙賓

??【編號】：NIBSC00/416

??【名稱】：用于脊髓灰質炎1型脊髓灰質炎病毒的MAPREC測定的低突變病毒參考（沙賓

??【規(guī)格】：個

??【價格】：2600元

　　用于脊髓灰質炎1型脊髓灰質炎病毒的MAPREC測定的低突變病毒參考（沙賓）（第一國際參考制劑）

　　編號：NIBSC00/416

　　英文：Low Mutant Virus Reference for MAPREC assay of poliovirus type 1 (Sabin)(1st International Reference Preparation)

　　標準類型：國際參考制劑

　　規(guī)格：1個

Customer Notes 00/410 - MAPREC assay of poliovirus type 1 (Sabin).100% 480-A, 525-C DNA(1st International Reference Preparation) 00/418 - MAPREC assay of poliovirus type 1 (Sabin) (1st International Standard) 00/422 - MAPREC assay of poliovirus type 1 (Sabin)High Mutant Virus Reference(1st International Reference Preparation)

　　描述：1. INTENDED USE

This Low Mutant Virus Reference (LMVR) is intended to be used as a

control to determine whether an individual determination is valid in the

MAPREC assay. The % 480-A and 525-C content of the candidate

reference materials were chosen such that the biological variation

inherent in the MAPREC method would lead to an invalid result in only

about 1 in 100 determinations.

2. CAUTION

This preparation is not for administration to humans or animals in

the human food chain.

The material is of bovine origin. The material is certified to be obtained

from animals taken from a closed herd in the female line since 1980, in

which no animal has been clinically suspected of having BSE & which

has not been fed rations containing ruminant derived protein during

that period.

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

00/416 is assigned a value of 1.84% 480-A, 525-C, on the basis of a

WHO collaborative study.

4. CONTENTS

Country of origin of biological material: USA.

Each vial contains approximately 0.5ml of poliovirus type 1 (Sabin) grown

in serum free medium. Two poliovirus stocks containing 100% 480-A,

525-C, and 100% 480-G, 525-T were produced by PCR site directed

mutagenisis from cloned DNA. This DNA was reverse transcribed in vitro

and transfected into HEp2c cells. Before preparing the bulk, the stocks

were mixed in different proportions and tested by MAPREC to determine

the appropriate volumes of stock in the final bulk suspension that was

filled as 00/416.

5. STORAGE

The material should arrive frozen.

Unopened ampoules should be stored at –70°C or below.

6. DIRECTIONS FOR OPENING

Vials have a „flip-up? circular cap. Either on the cap or the collar of the

vial, there is an indication of the point at which to lever off the cap. This

exposes an area of the stopper through which reconstitution and

withdrawal of the preparation can be made using a hypodermic needle

and syringe. If use of a pipette is preferred, then fully remove the metal

collar using, for example, forceps, taking care to avoid cuts by wearing

appropriate gloves. Remove the stopper for access. Care should be

taken to prevent loss of the contents.

7. USE OF MATERIAL

A Standard Operating Procedure for the MAPREC assay is available

from; Chief, Biologicals, World Health Organization. This procedure

requires that an aliquot of 00/416 is tested in each MAPREC assay 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.

c) WHO/BS/09.2103. WHO Technical Report Series.

10. ACKNOWLEDGEMENTS

We would like ackowledge the help of the participants of the WHO

collaborative study to evaluate the Poliovirus type 1 MAPREC assay.

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用于脊髓灰質炎1型脊髓灰質炎病毒的MAPREC測定的低突變病毒參考（沙賓）（第一國際參考制劑）

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