放射免疫测定AFP的内质量控制

INTERNAL QUALITY CONTROL OF AFP DETERMINATION BY RADIOIMMUNOASSAY

用不同浓度甲胎蛋白（ＡＦＰ）混合血清，制作成低、中、高三种不浓度质控血清，常规用于ＡＦＰ放射免疫分析。采用ｌｏｇｉｔｙ─ｌｏｇｘ线性回归法进行数据处理。未知样品由ｌｏｇｉｔｙ＝ａ＋ｂｌｏｇｘ计算出来。质量控制参数及质控血清测定值：ｒ＝≥０．９９；ＲＥＲ为３．３３±１．０２％；ＥＤ７０、ＥＤ５０和ＥＤ３０（μｇ／ｌ）分别为３１±５．３２、８６±１１．５６和１８２±２７．９５；三种质控血清（μｇ／ｌ）分别为３９．４±４．５８（ＣＶ为１１．６％）、１６４．８±１４．７６（ＣＶ为９％）和３６４±２１．６６（ＣＶ为６．２６％）。以上参数及三组ＱＣ血清１０次测定结果的平均值为基数或靶值，以±Ｓ、±２ｓ、±３Ｓ为界限值作图。认为，该法能从标准曲线、质控样品和操作水平来有效地控制放射免疫测定ＡＦＰ的质量。

Several mixed serums containing AFP of different concentration were used to make 3kinds of quality control serums,namely low, middling and high AFP concentration,which were routinelyapplied to AFP determination by radioimmunoassay.Logit y-logx linear regression analysis was adopted inprocessing data;the content of AFP in unknown speciments were calculated by logit y=a+blogx. Linearregression coefficient of standard curve,response error relationship,ED70,ED50,and ED30 were selectedas quality control parameters.The determined values of quality control serums and parameters were asfollows:r≥0.99;RER=3.33± 102%;ED70=31±5.32μg/L;ED50=86±11. 56μg/L;ED30=182±27.95μg/L; three qulity contral serums(μg/L)Were 39.4±4.58(cv=11.6%),164.8±14.76(cv=9%)and 364±2l.66 (cv=6.26%)respectively.Quality control charts were plottedrespectively in Which the average value of 10 determined data from the same quality control serum orparameter was taken as target value or the base,and the standard deviation as control limit.The authorsbelieve that the quality control method can effectively control the quality of AFP determination byradioimmunoassay through standard curve,quality control speciment amd operative level.