IFU HEV RNA reference panel戊型肝炎病毒检测标准品 BioVector NTCC质粒载体菌种细胞基因保藏中心

IFU HEV RNA reference panel戊型肝炎病毒检测标准品

1st World Health Organization International Reference
Panel for Hepatitis E Virus (HEV) Genotypes for Nucleic
Acid Amplification Technique (NAT)-Based Assays
PEI code 8578/13
(Version 2.0, November 2015)
1. INTENDED USE
The current WHO International Standard (IS) material for
hepatitis E virus (HEV) is genotype 3a (1). In order to reflect
HEV genetic diversity and the global disease burden of acute
hepatitis E, a genotype panel has been prepared which
contains representative strains of all four HEV genotypes and
important sub-genotypes.
The reference panel consists of 11 HEV positive samples
(plasma and stool-derived) further diluted in pooled human
plasma. The samples, their code numbers, as well are their
HEV (sub-)genotype are listed in the appended Table. The
panel has been evaluated in an international collaborative
study where the samples were tested concurrently with the 1st
WHO IS (6329/10).
The material has been lyophilized in 0.5 ml aliquots and
stored at -20°C. The material has been evaluated in an
international collaborative study involving 24 laboratories
performing a wide range of HEV NAT assays. Further details
of the collaborative study are available in the report
WHO/BS/2015.2264.
2. UNITAGE
No unitage has been assigned to the individual panel
members. The IU for HEV RNA is defined by the current WHO
International Standard, which is a genotype 3a virus. The
panel is not intended to replace the IS for HEV RNA.
However, in the international collaborative study (based upon
data returned by 17 laboratories from quantitative assays), the
mean titres of panel members were determined and are
provided below, for information only.
The values were obtained by comparison to the genotype 3a
International Standard using current assays represented in the
collaborative study. Further details of the collaborative study
are available in the report WHO/BS/15.2264.
3. CONTENTS
Each vial contains 0.5 ml of lyophilized plasma containing
infectious HEV.
4. CAUTION
THIS PREPARATION IS NOT FOR ADMINISTRATION TO
HUMANS.
The preparation contains material of human origin, and
contains infectious HEV. The reference materials has been
diluted in human plasma negative for HBV DNA, HCV RNA,
HEV RNA, HIV-1/2 RNA, HBsAg, anti-HEV, anti-HCV, and
anti-HIV-1/2.
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
probably will include the wearing of protective gloves and
avoiding the generation of aerosols. Care should be exercised
in opening ampoules or vials, to avoid cuts.
5. USE OF MATERIAL
No attempt should be made to weigh out any portion of the
freeze-dried material prior to reconstitution.
The material is supplied lyophilized and should be stored at or
below-20ºC. Each vial should be reconstituted in 0.5 ml of
sterile nuclease-free water. The product should be
reconstituted just prior to use, once reconstituted, freeze
thawing of the product is not recommended. If not all the
material is used immediately, laboratories may aliquot the
remaining material into suitable volumes which should be
stored at or below -70ºC.
6. STABILITY
As the stability studies with accelerated conditions indicate
high stability of the lyophilized reference material under the
recommended storage conditions (at or below-20ºC), there is
no expire date assigned to the international reference panel.
This approach complies with the recommendations for the
preparation, characterization and establishment of
international and other biological reference standards (3). The
reference material is held at the Paul-Ehrlich-Institut (PEI)
within assured, temperature-controlled storage facilities.
During its life cycle the stability is monitored at regular
intervals.
Reference materials should be stored on receipt as indicated
on the label. Once, diluted or aliquoted, users should
determine the stability of the material according to their own
method of preparation, storage and use.
Users who have data supporting any deterioration in the
characteristics of any reference preparation are encouraged to
contact PEI.
7. REFERENCES
(1) Baylis SA, Blümel J, Mizusawa S, Matsubayashi K, Sakata
H, Okada Y, Nübling CM, Hanschmann KM; HEV
Collaborative Study Group. World Health Organization
International Standard to harmonize assays for detection of
hepatitis E virus RNA. Emerg Infect Dis. 2013;19:729-35.
(2) Baylis SA, Terao E, Hanschmann KM. Collaborative Study
to Establish the 1st World Health Organization International
Reference Panel for Hepatitis E Virus RNA Genotypes for
Nucleic Acid Amplification Technology (NAT)-Based Assays.
WHO Report 2015, WHO/BS/2015.2264.
(3) Recommendations for the preparation, characterization
and establishment of international and other biological
reference standards. WHO Expert Committee on Biological
Standardization. Fifty-fifth report, 2004. (WHO Technical
Report Series, No. 932).
8. ACKNOWLEDGEME

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