New and replacement WHO standards and guidelines established by ECBS

New and replacement WHO standards developed by the NIBSC have been established by the WHO Expert Committee on Biological Standardisation (ECBS).

The annual meeting of the ECBS took place in October 2020 and was followed by an exceptional meeting held in December to address urgent issues related to the COVID-19 pandemic.

The purpose of these meetings was to review proposals for new and replacement WHO International Standards (IS) and International Reference Reagents (IRR). Each proposal was accompanied by data from an extensive international collaborative study, involving multiple laboratories, designed to characterise and evaluate the suitability of the candidate material.

In total, the NIBSC had eleven new standards and three replacement standards established across the two meetings. This includes three new standards that have been rapidly developed to support diagnostics, vaccine development and research into COVID-19.

Additionally, two sets of WHO written standards developed by the NIBSC supporting the production and evaluation of vaccines were also recommended for adoption. 

A full list of the newly established WHO standards developed by the institute is provided below.

New and replacement standards that have not yet been added to the NIBSC catalogue will be made available over the coming months. Sign up to our mailing list and follow us on social media to receive updates.

Coronavirus standards

•         1^st WHO IS for SARS-CoV-2 RNA for NAT-based assays (NIBSC code: 20/146)
•         1^st WHO IS for Anti-SARS-CoV-2 immunoglobulin (NIBSC code: 20/136)
•         WHO IRR for Anti-SARS-CoV-2 immunoglobulin panel (NIBSC code: 20/268)
•         1^st WHO IS for Anti-MERS-CoV immunoglobulin G (human) (NIBSC code: 19/178)

Monoclonal antibody standards

•         1^st WHO IS for Bevacizumab (NIBSC code: 18/210)
•         1^st WHO IS for Trastuzumab (NIBSC code: 19/108)

Nucleic acid standards for diagnostics

•         1^st WHO IS for Herpes simplex virus type 1 DNA for NAT-based assays
•         1^st WHO IS for Herpes simplex virus type 2 DNA for NAT-based assays
•         1^st WHO IS for West Nile virus lineage 1 RNA for NAT-based assays (NIBSC code: 18/206)
•         WHO IRR for West Nile virus lineage 2 RNA for NAT-based assays (NIBSC code: 18/208)

Other standards

•         WHO IRR for Anti-human platelet antigen-15b immunoglobulin G (human)
•         6^th WHO IS for Chorionic gonadotrophin (human) (NIBSC code: 18/244)
•         2^nd WHO IS for Insulin-like growth factor-I (recombinant, human) (NIBSC code: 19/166)
•         3^rd WHO IS for Interferon alpha 2b

Written Standards

•         Guidelines for Typhoid conjugate vaccines were adopted (revision)
•         Guidelines for EV71 vaccines were adopted (new)

Further information 

The executive summaries of both the October and December ECBS meetings are available from the WHO website.

72^nd ECBS meeting (19 to 23 October 2020)

73^rd ECBS meeting (9 to 10 December 2020)

If you require more information about any of the standards listed here please contact standards@nibsc.org.