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KMID : 0370220010450060656
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Yakhak Hoeji
2001 Volume.45 No. 6 p.656 ~ p.663
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C1q-Coated Microtitre Enzyme-linked Immunosorbent Assay for Measuring the Anticomplementary Activity of Intravenous Immunoglobulin Preparations
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강혜나/Kang HN
김순남/신광훈/허숙진/Kim SN/Shin KH/Hur SJ
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Abstract
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The quality of an intravenous immunoglobulin preparation (IVIG) is reflected by the degree of nonspecific activation of complements, the so-called anticomplementary activity (ACA). ACA of aggregates in IVIG was investigated using method by the European Pharmacopoeia and C1q-coated microtiter enzyme-linked immunosorbent assay (ELISA). Both the EP method and the ELISA method showed a dose response curve with the amount of complements bound increasing with the percentage content of aggregates in immunoglobulin standard. The correlation between the two tests was good (r=0.96, r=0.99). However the correlation was not found when the ACA (EP method) of IVIG product was compared with its aggregate percentage. These results emphasize that the method of aggregate formation affects ACA and that estimation of the percentage distribution of aggregates by HPLC may not reflect ACA. In analysing IVIG product for C1q binding activity test with the ELISA, the result by using Protein A-HRP correlated with aggregate percentage (r=0.84). But the correlation decreased (r=0.48) when the result used Protein A-AP(having poorer sensitivity than HRP) was compared with aggregate percentage. As a result, some variation between the two methods, due to differences in assay principles, is to be expected. However ELISA technique has the advantage in that it is easier to perform, more precise and less subject to reagentvariability and is the more suitable screening method than HPLC analysis.
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