Study on Safety of Intravenous Immunoglobulin (IVIG) Maeketed in Thailand from antibody titers ABO and Rh blood group
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Abstract
Human normal immunoglobulin for intravenous administration (IVIG) is a plasma-derived product produced from human plasma by Cohn-fractionation technique. It is intended for non-specific passive immunity treatment. The plasma for fractionation is obtained from human blood containing mainly ABO and Rh blood group. The IVIG product may contain residual anti-A/B (antibody to ABO blood group) and anti-D (antibody to Rh blood group) that may be harmful to consumers. For safety of the product according to the European Pharmacopoeia 9.0 requirements, when analyzing the product at a protein concentration of 25 g/l, anti-A/B and anti-D titres should be less than or equal to 1:64 and less than 1:8, respectively. Six brands of IVIG products totally marketed in Thailand between 2015 and 2016 (not expired in 2017), were tested for anti-A/B and anti-D by direct haemagglutination method. The results revealed that all samples passed the test criteria and most anti-A/B and D titers were 1:4 to 1:16 and negative, respectively. In conclusion, these products were safe for consumers.
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