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In enzyme-liked immunosorbent assay (ELISA) of HBsAg with Hepanostika Microelisa system (Organon Teknika, B.V.) on 1270 sera with negative HBsAg and 40 sera with positive HBsAg, the cutoff value based on the mean absorbance of HBsAg-negative sera was found inadequate in both theoretical and practical aspects. It was more reasonable to subtract the mean absorbance of negative controls as a blank and to obtain a lower detection limit from the standard deviation using a calibration curve prepared with a known standard of HBsAg. The results were reproducible in the revised precedure and could be expressed on a linear scale in absolute quantity. The linear range covered by ELISA was wider than RIA and the assay of samples with higher HBsAg levels could be readily repeated for quantitation by appropriate dilutions.<BR>The HBsAg concentration of human sera distributed in a wide range from 6.7ng/ml to 600μg/ml, and the sera giving HBsAg above 100μg/ml had all positive HBeAg.<BR>A new kit of Hepanostika HBsAg Microelisa system (Organon Taknika, B.V.) had a lower detection limit of 0.3ng/ml, comparable to that of RIA, while keeping a linear range of calibration curve up to 30ng/ml with reproducible results.<BR>Thus, the quantitation of HBsAg by ELISA system may prove to be a clinically useful tool not only in the screening of HBsAg-positive cases but also in the quantitation of HBsAg concentration for followup of HBsAg carriers and treatment of HBV-induced hepatitis.
- 社団法人 日本肝臓学会の論文
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