Establishment of New and Replacement WHO Standards

The WHO Expert Committee on Biological Standardization (ECBS) held its 70^th annual meeting in Geneva on the 21-25 October 2019.

The purpose of this meeting was to review proposals for the establishment of new or replacement WHO international standards and reference reagents. Each proposal was submitted following an extensive international collaborative study, involving multiple laboratories, designed to characterise and evaluate the suitability of the candidate material.

In total, 21 new standards and 6 replacement standards from NIBSC were established. These standards will be added to our catalogue as they become available. Follow us on twitter to receive updates.

A complete list of the new and replacement WHO standards developed by NIBSC, that were established at the ECBS meeting can be found below.

New Standards

First WHO International Standards:

Darbepoetin
Adalimumab
Blood coagulation factor XIII-B subunit (total)
HCT 15 cancer genome
MOLT-4 cancer genome
ATDB102 reference genome
EV71 inactivated vaccine
Antiserum to respiratory syncytial virus subtype B
Meningococcal capsular group W polysaccharide
Meningococcal capsular group Y polysaccharide
Human papillomavirus type 6 DNA for NAT-based assays
Human papillomavirus type 11 DNA for NAT-based assays
Human papillomavirus type 31 DNA for NAT-based assays
Human papillomavirus type 33 DNA for NAT-based assays
Human papillomavirus type 45 DNA for NAT-based assays
Human papillomavirus type 52 DNA for NAT-based assays
Human papillomavirus type 58 DNA for NAT-based assays

First WHO Reference Reagents:

Lentiviral vector integration site analysis
EV71 genotype C4 inactivated vaccine
EV71 genotype B4 inactivated vaccine

First WHO International Reference Panel:

Lentiviral vector copy number

Replacement Standards

Prekallikrein activator (Third WHO International Standard)
Streptokinase (Fourth WHO International Standard)
Anti-tetanus immunoglobulin (human) (Second WHO International Standard)
Hepatitis C virus RNA for NAT-based assays (Sixth WHO International Standard)
Insulin (human) (Second WHO International Standard)
Tetanus toxoid for use in flocculation test (Third WHO International Standard)

The executive summary of ECBS 2019 has now been published by WHO. If you would like more information about any of the standards listed here please contact standards@nibsc.org.