Romain S, Formento J L, Guirou O, Francoual M, Milano G, Martin P M
Laboratoire de Cancérologie Biologique, APM, Faculté de Médecine de Marseillesecteur Nord, France.
Eur J Cancer. 1994;30A(6):740-6. doi: 10.1016/0959-8049(94)90285-2.
When multicentre breast cancer trials are performed, receptor analyses must be comparable both over time and in the participating laboratories. However, we show for the first time a high variability for the distribution of oestradiol receptor (ER) values measured by enzyme immunoassay (EIA) from 1987 to 1991. This variability could be explained by calibration changes in the immunoassay kits. We have also analysed the influence on ER-EIA levels of technical differences between laboratories apart from the assay itself. Many steps emerged as being critical, i.e. homogenisation buffer, homogenisation procedure and cytosol dilution. Finally, we show that addition of 4-monohydroxytamoxifen increases the apparent ER content measured by EIA in 92% of cytosols. Thus, many factors must be controlled to ensure high precision with ER-EIA assays. We have to be particularly cautious with the conformational changes that could occur during cytosol preparation and that could also pre-exist in the tumour samples. Quality controls of cytosol preparation are essential.
在进行多中心乳腺癌试验时，受体分析在时间上以及参与研究的各实验室之间都必须具有可比性。然而，我们首次发现，1987年至1991年期间通过酶免疫测定法（EIA）测得的雌二醇受体（ER）值分布存在很大差异。这种差异可以用免疫测定试剂盒的校准变化来解释。我们还分析了除检测方法本身外，各实验室技术差异对ER-EIA水平的影响。许多步骤被证明至关重要，即匀浆缓冲液、匀浆程序和胞质溶胶稀释。最后，我们发现添加4-单羟基他莫昔芬可使92%的胞质溶胶中通过EIA测得的表观ER含量增加。因此，必须控制许多因素以确保ER-EIA检测具有高精度。我们必须特别注意在胞质溶胶制备过程中可能发生的构象变化，这些变化也可能预先存在于肿瘤样本中。胞质溶胶制备的质量控制至关重要。
