免疫球蛋白製劑之B型肝炎表面抗原及抗人類免疫缺乏病毒抗體檢測

DETECTION OF HEPATITIS B SURFACE ANTIGEN AND ANTI-HUMAN IMMUNODEFICIENCY VIRUS IN IMMUNOGLOBULIN INJECTIONS

為了瞭解市售國產及輸入免疫球蛋白製劑的品質，從民國74年9月至75年5月，於台灣地區醫院藥局抽購免疫人血清球蛋白製劑11廠牌47批號檢體72件，破傷風免疫球蛋白製劑4廠牌5批號檢體5件，合計12廠牌52批號檢體77件，分別以放射免疫分析法檢測B型肝炎表面抗原；酵素免疫分析法檢測抗人類免疫缺乏病毒抗體，又其中抗人類免疫缺乏病毒抗體呈陽性的批號檢體，另以西方墨點法做確認及以酵素免疫分析法檢測人類免疫缺乏病毒抗原。其檢驗結果在全部受檢之52批免疫球蛋白製劑檢體中，B型肝炎表面抗原均呈現陰性（-）；而在抗人類免疫缺乏病毒抗體方面：以酵素免疫分析法檢測中計呈強陽性（++）反應者23批（44.2%），陽性（+）反應者10批（19.2%），不確定反應（±）者6批（11.6%），陰性反應者（-）13批（25%）。又前項人類免疫缺乏病毒抗體強陽性及陽性反應之33批次製劑檢體，西方墨點陽性及酵素免疫分析人類免疫缺乏病毒抗原陰性（-）。結果顯示，藥廠以未經抗人類免疫缺乏病毒抗體篩選的血源製造。免疫人血清球蛋白和破傷風免疫球蛋白製劑，會被抗人類免疫缺乏病毒抗體所污染，而該病毒抗原則未檢出。

In order to survey the quality of domestic and imported immunoglobulin injections used in market, 11 brands 47 lots 72 preparations of Human Normal Immunoglobulin Injection, 4 brands 5 lots 5 preparations of Human Antitetanus Immunoglobulin Injection, totaled 12 brands 52 lots 77 preparations were sampled from September 1985 to May 1986 in Taiwan area. The preparations were assayed to detect HBsAg by RIA and Anti-HIV by ELISA. The Anti-HIV positive lots were assayed further by Western Blot for Anti-HIV confirmation and by ELISA for HIV-Ag. The results showed that 52 lots (100%) are negative for HBsAg; 23 lots ( 44. 2%) strong positive , 1 lots (19.2%) postitive, 6 lots (11.6%) borderlined, 13 lots (25%) negative for Anti-HIV in 52 lots immunoglobulin injections . The 33 lots of Anti-HIV strong positive and positive injections are all positive by Western Blot for Anti-HIV and negative by ELISA for HIV-Ag. The results indicated that preparations of Human Normal and Antitetanus Immunoglobulin Injection produced from unscreened blood source for Anti-HIV by manufactories are contaminated with Anti-HIV but HIV-Ag is negative.