Stable assay and reference standards platform

HPA–NIBSC Biological Standards Board (A Centre of the HPA), South Mimms, Potters Bar, UK.

HPA-NIBSC is an internationally recognised laboratory preparing, characterising and distributing Reference Reagents and Standards worldwide. The linkage of HPA-NIBSC and CFAR (Centre for AIDS Reagents) within HPA-NIBSC provides a unique resource to ensure a new infrastructure providing immune assay reference standards and specified pathogen reagents to the vaccine research community.

Central to harmonisation and subsequent assay qualification and potential validation for use in clinical trials, is the requirement for suitable and relevant reference reagents. A programme is underway to establish, characterise and make available to the vaccine research community reference standards for currently applied immune assays.

HPA-NIBSC offers advice and practical assistance in the process of preparing, formulating reference reagents: this may include freeze dried formulation, determining properties of the processed product (for example residual moisture, microbiological status and homogeneity of the product), trial to ensure that the formulation is “fit for purpose”, final fills at a range of scales, accelerated degradation studies for stability testing, curateship and despatch of reference reagents

Modalities of Access to the Infrastructure

Overview of access provided between January 2011 (1st call) and April 2013 (10th call):
Min. quantity of access to be provided: 164
Estimated number of users/User groups: 12
Estimated number of projects: 4
Access already provided: 164
Access still available: 0

There are two different Access Modalities

1)         Reference or Standard Preparation: This is a front to back service access, with NIBSC providing the expertise to prepare and characterise a reference reagent from purified or specified materials supplied by the applicant. The fill size will vary and NIBSC will act to characterise and will undertake responsibilities as curator and distributor of the Reference Reagent.

User will provide material required for formulation into reference or standard. Details will vary widely depending upon agreed requirements, for example, may be a few mg of purified recombinant protein. This material will be developed as a reference or standard for use in assays, with data on instructions for use, specifications and limitations. This may include expert guidance on use and related aspects of assay qualification or validation as appropriate.

Unit of Access: Preparation and characterisation of a reference or standard preparation

Quantity of Access: One reference preparation prepared, characterised and available for use per application.

Last call submission date scheduled for: This service is only available via paid access. Funding capacity for free services is exhausted.

More details and application process and forms are here

2)         Supply of Existing Reagents/Standards/References:

The Infrastructure can make available specific references and standards such as

a) Immunoassays used in clinical trials -specific cytokine reference reagents, ICS (flow cytometry reference reagents such as a CD4+ Interferon gamma positive biased preparation) and early stage ELISpot reference reagents based on the ICS flow reagent.

b) Pathogen specific reagents for research, assay development and calibration of internal references

c) Other specific and relevant reference and standards currently available within NIBSC/CFAR catalogue

Links to other Reference Reagents are here.

Unit of Access: one reference reagent (Quantity dependent upon requirements, availability and proposed use, usually a maximum of 10 vials per reference or standard per request).

Quantity of Access: up to 12 different reference reagents

Last call submission date scheduled for: This service is only available via paid access. Funding capacity for free services is exhausted.

The procedure for applying for access to these reagents via the TRANSVAC Infrastructure is here.


Donna Bryan

Donna [dot] Bryan [at] nibsc [dot] hpa [dot] org [dot] uk

+44 1707 641000[MMH1] [CED2]  

 [MMH1]Yes, you can use this website on the form and website.

 [CED2]This is the link that you sent to Mark. Can I put it here and on the website?