Navarro Moreno M A, Rivera-Coll A, Huguet Ballester J, Bonnin Lafuente M R
Sección de Hormonas, Hospital Princeps d'Espanya, Barcelona, Spain.
Eur J Clin Chem Clin Biochem. 1991 Sep;29(9):569-72.
The Enzymun-Test System ES-600 is a fully automated analyser for the Clinical Chemistry hormone laboratory. The Enzymun-Test prolactin, an enzyme immunoassay, is based on a sandwich technique using two monoclonal antibodies, one coated onto tubes and the other labelled with peroxidase. We have studied the measurement of prolactin concentration in serum and compared the results obtained with both this system and with the manual IRMA used in our laboratory. The within-day imprecision gave the following CV (n = 20): 6% at 64 mU/l, 1% at 379 mU/l and 2% at 1232.1 mU/l. The CV for between-day imprecision (n = 20) was 10%, 8% and 6%, respectively. The detection limit was 4 mU/l and linearity was demonstrated with geometric dilutions of a highly concentrated serum. We observed an average recovery of 104%, ranging 95.6%-110%. The calculated carryover was of 0.05%, and there was no trend in the measurements to indicate the occurrence of long series drift. In the study of interchangeability (Passing-Bablok regression test) we obtained a linear equation: y (ES-600) = 3.16 mU/l + 0.82 x (IRMA), with the confidence intervals (95%) a(-30.69, 21.53); b(0.73, 0.99); and a correlation coefficient of r = 0.98.
酶免疫检测系统ES - 600是一款用于临床化学激素实验室的全自动分析仪。酶免疫检测催乳素是一种酶免疫测定法，基于夹心技术，使用两种单克隆抗体，一种包被在试管上，另一种用辣根过氧化物酶标记。我们研究了血清中催乳素浓度的测量，并比较了使用该系统和我们实验室使用的手动免疫放射分析（IRMA）所获得的结果。日内不精密度给出了以下变异系数（n = 20）：64 mU/l时为6%，379 mU/l时为1%，1232.1 mU/l时为2%。日间不精密度的变异系数（n = 20）分别为10%、8%和6%。检测限为4 mU/l，通过高浓度血清的几何稀释证明了线性关系。我们观察到平均回收率为104%，范围在95.6% - 110%之间。计算得出的携带污染率为0.05%，测量中没有趋势表明存在长序列漂移。在互换性研究（Passing - Bablok回归检验）中，我们得到了一个线性方程：y（ES - 600）= 3.16 mU/l + 0.82x（IRMA），其置信区间（95%）为a（-30.69，21.53）；b（0.73，0.99）；相关系数r = 0.98。
