Collaborative study for establishment of a global standard for the potency assay of human anti-D immunoglobulin. Pharmeuropa Bio 2004 Jan;2003(2):9-26
Date
02/13/2004Pubmed ID
14960260Scopus ID
2-s2.0-16544374154 (requires institutional sign-in at Scopus site) 1 CitationAbstract
An international collaborative study aimed at establishing a global standard for the potency assay of anti-D immunoglobulin was started in 2002. 25 laboratories participated in this study run under the common aegis of the World Health Organization, the United States Food and Drug Administration (US-FDA) and the European Directorate for the Quality of Medicines (EDQM). The potencies of three candidate materials and the US-FDA standard (lot 3) included for comparison were evaluated using AutoAnalyzer, competitive enzyme-linked immunoassay (competitive EIA), flow cytometric methods or own "in-house" methods. Critical reagent, standardised procedures and standardised assay design were provided for either method, where appropriate. Central statistical evaluation of the potency data submitted by the participants was performed using a parallel line model. Agreement between laboratories and assay methods for all samples was observed. Intra-laboratory variability was lowest for laboratories performing flow cytometry and highest for laboratories that performed their in-house methods. Inter-laboratory variability was acceptable for all samples when assayed by AutoAnalyzer, competitive (EIA) and flow cytometric methods. It was concluded that sample A is most suitable to serve as a global standard and that sample C could serve as a reserve European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) batch provided that suitable stability is demonstrated. Sample A was adopted by the Ph. Eur. Commission at its 115th session (March 2003) as the first Ph. Eur. BRP (available from the EDQM: catalog number Y0000219) with the assigned potency of 285 IU/ampoule.
Author List
Thorpe SJ, Sands D, Fox B, Schäffner G, Yu MW, Behr-Gross MEMESH terms used to index this publication - Major topics in bold
Chromatography, High Pressure LiquidEurope
Flow Cytometry
Humans
Immunoassay
International Cooperation
Laboratories
Pharmacopoeias as Topic
Reference Standards
Rho(D) Immune Globulin
United States
World Health Organization
