世衛組織首個國際標準抗SARS-CoV-2免疫球蛋白（人類）

??【編號】：NIBSC20/136

??【產品名稱】：世衛組織首個國際標準抗SARS-CoV-2免疫球蛋白（人類）

??【規格】：個

??【價格】：斷貨

　　世衛組織首個國際標準抗SARS-CoV-2免疫球蛋白（人類）

　　編號：NIBSC20/136

　　英文：First WHO International Standard Anti-SARS-CoV-2 Immunoglobulin (Human)

　　標準類型：國際標準

1. INTENDED USE

The First WHO International Standard for anti-SARS-CoV-2

immunoglobulin is the freeze-dried equivalent of 0.25 mL of pooled

plasma obtained from eleven individuals recovered from SARS-CoV-2

infection. The preparation has been evaluated in a WHO International

Collaborative study (1). The intended use of the International Standard is

for the calibration and harmonisation of serological assays detecting antiSARS-CoV-2

neutralising antibodies. The preparation can also be used

as an internal reference reagent for the harmonisation of binding antibody

assays. The preparation has been solvent-detergent treated to minimise

the risk of the presence of enveloped viruses (2).

2. CAUTION

This preparation is not for administration to humans or animals in

the human food chain.

The preparation contains material of human origin, and either the final

product or the source materials, from which it is derived, have been

tested and found negative for HBsAg, anti-HIV and HCV RNA. 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

The assigned potency of the WHO International Standard for SARS-CoV2

is 250 IU/ampoule for neutralising antibody activity. After reconstitution

in 0.25 mL of distilled water, the final concentration of the preparation is

1000 IU/mL.

For binding antibody assays, an arbitrary unitage of 1000 binding antibody

units (BAU)/mL can be used to assist the comparison of assays detecting

the same class of immunoglobulins with the same specificity (e.g. antiRBD

IgG, anti-N IgM, etc.)

4. CONTENTS

Country of origin of biological material: United Kingdom.

Each ampoule contains the freeze-dried equivalent of 0.25 mL pooled

human plasma.

5. STORAGE

The International Standard 20/136 should be stored at -20°C or below

upon receipt.

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 reconstitutionThis material should be reconstituted in 0.25 mL sterile distilled water.

Following addition of water, the ampoule may be left at ambient temperature

for approximately 30 minutes until dissolved and then mixed thoroughly,

avoiding the generation of excessive foam.

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

(1) Mattiuzzo et al. Establishment of the WHO International Standard and

Reference Panel for anti-SARS-CoV-2 antibody. 2020, WHO Expert

Committee on Biological Standardization. WHO/BS/2020.2403

(2) Dichtelmüller et al. Robustness of solvent/detergent treatment of plasma

derivatives: a data collection from Plasma Protein Therapeutics Association

member companies. Transfusion. 2009;49:1931–43.

10. ACKNOWLEDGEMENTS

We would like to wholeheartedly thank the anonymous donors of the plasma

samples for their consent which has allowed this material to be prepared; we

would like to express our gratitude to those groups and individuals who have

coordinated the collection of the convalescent plasma: Malcom Semple

(Univeristy of Liverpool, UK), Lance Turtle (University of Liverpool, UK),

Peter Openshaw (Imperial College London, UK) and Kenneth Baillie

(University of Edinburgh) on behalf of the ISARIC4C Investigators; Heli

Harvala Simmonds and David Roberts (National Health Service Blood and

Transplant, UK). We would also like to thank NIBSC Standards Production

and Development staff for the formulation and distribution of materials. The

Internatinal Standard for SARS-CoV-2 antibody wouldn't have been possible

without the Coalition for Epidemic Preparedness Innovations (CEPI)

sponsored the sourcing and formulation of the candidate material.

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