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研究了两种免疫学方法及生物检定法测定血清肿瘤坏死因子衍生物（ｒｈＴＮＦαＤａ）的方法学，并对三种方法测定的药代动力学样本数值进行了相关分析。ＢｏｅｈｒｉｎｇｅｒＭａｎｎｈｅｉｍＢｉｏｃｈｅｍｉｃａ（ＢＭ）公司药盒的灵敏度和线性范围分别为０．０４２μｇ／Ｌ和０．０４２～３．４４μｇ／Ｌ；邦定药盒的灵敏度、线性范围、重复性和回收率分别为２２．４４μｇ／Ｌ、２．４４～６２５μｇ／Ｌ、ＣＶ＜７．２％和８８．７～１０２．９％；生物检定法分别为０．９μｇ／Ｌ、０．９～２２２μｇ／Ｌ、ＣＶ＜３０．６％和７５．８～８５．１％。三种方法都基本上不受正常血清的干扰，特异性较好。用三种方法测定的药代动力学样本的数值间都有高度的相关性，说明在测定ｒｈＴＮＦαＤａ时，免疫法可以部分地反映生物活性，免疫法与生物检定法之间有一定的可比性。
Two immunological and bioassay methods for the determination of serum tumor necrosis factor derivatives (rhTNFαDa) were studied, and the values of the three pharmacokinetic samples determined by the three methods were analyzed. The sensitivity and linearity range of Boehringer Mannheim Biochemica (BM) kit were 0.042μg / L and 0.042 ~ 3.44μg / L, respectively. The sensitivity, linearity range, repeatability and recovery of the conjugate kit were 22.44μg /L,2.44~625μg/L,CV<7.2% and 88.7~102.9%. The bioassay methods were 0.9μg / L, 0.9 ~ 222μg / L and CV <30 respectively. 6% and 75.8 ~ 85.1%. The three methods are basically free from the interference of normal serum, specificity is better. There is a high degree of correlation between the values of the pharmacokinetic samples measured by the three methods, indicating that the immunoassay may partially reflect the biological activity in the determination of rhTNFαDa, and there is some comparability between the immunoassay and the bioassay.