Carmann H, van Dalen A, van Kampen E J, Keogh H, Lüdin E, Orjasaeter H, van der Ploeg P, Staab H J
J Clin Chem Clin Biochem. 1981 Sep;19(9):961-5. doi: 10.1515/cclm.1981.19.9.961.
An interlaboratory study on the reproducibility of the CEA (Roche) RIA Test was carried out. Four different plasma pools of approximately 2, 3, 6, and 12 micrograms/l CEA were tested over a period of 4 weeks with 4 different lots of reagents in order to determine the interassay variances. At the same time we compared the lately introduced column technique with the dialysis and ultrafiltration method. Best results were obtained with the column technique which also showed best reproducibility. Only 1.4% of samples showed deviations greater than 5% between the mean of CEA duplicates and single CEA values, and these were omitted from the evaluation. On the other hand about 15% of the corresponding dialysis results showed deviations greater than 5% and were excluded from the evaluation. The methods compared showed a good correlation with a coefficient of 0.96, but the average values for the CEA determination, using the columns technique were lower than those obtained from dialysis. Interassay variances were greater for the dialysis procedures, i.e. 1.88 +/- 0.81, 3.25 +/- 0.83, 5.81 +/- 1.09, and 11-91 +/- 1.23 compared with 1.77 +/- 0.54, 2.63 +/- 0.68, 4.89 +/- 0.79, and 11.16 +/- 1.23 for the column technique. There were no systematic changes of the CEA values over the period of 4 weeks, thus giving optimal conditions for a follow up of patients.
开展了一项关于癌胚抗原（罗氏）放射免疫分析检测重复性的实验室间研究。使用4个不同批次的试剂，对浓度约为2、3、6和12微克/升癌胚抗原的4种不同血浆混合样本进行了为期4周的检测，以确定批间差异。同时，我们将最新引入的柱技术与透析和超滤方法进行了比较。柱技术获得了最佳结果，其重复性也最佳。只有1.4%的样本在癌胚抗原重复检测平均值与单次癌胚抗原值之间的偏差大于5%，这些样本被排除在评估之外。另一方面，约15%的相应透析结果显示偏差大于5%，并被排除在评估之外。所比较的方法具有良好的相关性，相关系数为0.96，但使用柱技术测定癌胚抗原的平均值低于透析法获得的平均值。透析程序的批间差异更大，即1.88±0.81、3.25±0.83、5.81±1.09和11.91±1.23，而柱技术的批间差异为1.77±0.54、2.63±0.68、4.89±0.79和11.16±1.23。在4周期间癌胚抗原值没有系统性变化，从而为患者随访提供了最佳条件。
