Assessment of the Fc function in human immunoglobulins for intravenous administration. Multicenter study of the section 'Blood plasma Constituents' of the German Association for Transfusion Medicine and Immunohematology (DGTI).
BACKGROUND
The working group 'Blood plasma Constituents' of the DGTI has carried out a multicenter study with human immunoglobulins for intravenous administration (IVIG). The aim of the ring study was the determination of the reproducibility of the IVIG Fc function method proposed for the European IVIG monograph.


METHODS
Eight laboratories from Europe participated in this ring study. The test of Fc function was carried out according to a standardized procedure.


RESULTS
The results showed good consistency between the participating laboratories. The reproducibility of the method showed coefficients of variation of 5-10%.


CONCLUSIONS
All commercial IVIG preparations met the requirement of the Fc function of > or = 80% in relation to the Fc function of the standard, an immunoglobulin preparation for intramuscular (i.m.) administration.
Kotitschke
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D000917:Antibody Formation / Q000276:immunology; D000956:Antigens, Viral / Q000276:immunology; D006801:Humans; D007116:Immunization, Passive; D007141:Immunoglobulin Fc Fragments / Q000502:physiology*; D007262:Infusions, Intravenous; D011237:Predictive Value of Tests; D012412:Rubella virus / Q000276:immunology
D000956:Antigens, Viral; D007141:Immunoglobulin Fc Fragments