International collaborative study to establish immunoglobulin (anti-D test) BRP batch 1.
An international collaborative study was organised to establish a European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) and United States (US) Food and Drug Administration (FDA) reference preparation for the test for anti-D (anti-Rho) antibodies in human normal immunoglobulin for intravenous administration (IGIV). A candidate positive control (IGIV+anti-D) and negative control IGIV were compared to corresponding World Health Organization (WHO) International Reference Reagents using a direct haemagglutination reference method. Sixteen (16) laboratories participated in the collaborative study. Further to completion of the study, the materials assayed in the study were granted the status of Ph. Eur. and US FDA reference preparations for controlling the levels of anti-D in IGIV.
Thorpe
S J
SJ
NIBSC, Potters Bar, Herts EN6 3QG, UK.
Fox
B
B
Heath
A
A
Behr-Gross
M-E
ME
Virata
M L
ML
Yu
M W
MW
D005060:Europe; D006386:Hemagglutination Tests / Q000592:standards; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000737:chemistry / Q000302:isolation & purification / Q000592:standards*; D007391:International Cooperation; D010602:Pharmacopoeias as Topic; D012015:Reference Standards; D018029:Rho(D) Immune Globulin / Q000737:chemistry; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization
D016756:Immunoglobulins, Intravenous; D018029:Rho(D) Immune Globulin