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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
??【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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