Ebert W, Bodenmüller H, Hölzel W
Thoraxklinik der LVA Baden, A, Heidelberg, Germany.
Scand J Clin Lab Invest Suppl. 1995;221:72-80. doi: 10.3109/00365519509090568.
CYFRA 21-1 has proved to be a useful marker for non-small-cell lung cancer (NSCLC), which is the major form of lung cancer. Its most effective application is in monitoring. CYFRA 21-1 provides diagnostic information about the success of primary surgery, the response to chemotherapy and the detection of relapse. It is also an independent prognostic factor. The diagnostic potential may not be fully used because decision-making is currently based on group reference ranges. It seems useful to carry out systematic studies to investigate if the application can be improved and extended by using individual reference ranges for decision-making. In contrast to most of the other tumour markers the comparability of the commercial CYFRA 21-1- assays currently available on the market is good. The high degree of comparability should be maintained by international standardization. The analytical performance of the currently available commercial CYFRA 21-1 tests meets requirements derived from its current clinical applications. However, there are no data available about the analytical performance under field conditions. CYFRA 21-1, an established tumour marker for lung cancer, should be included in external quality assurance schemes.
细胞角蛋白19片段（CYFRA 21-1）已被证明是一种用于非小细胞肺癌（NSCLC）的有用标志物，非小细胞肺癌是肺癌的主要形式。其最有效的应用在于监测。CYFRA 21-1可提供有关原发手术是否成功、化疗反应以及复发检测的诊断信息。它也是一个独立的预后因素。由于目前的决策是基于群体参考范围，其诊断潜力可能未得到充分利用。开展系统性研究以调查使用个体参考范围进行决策是否能够改进和扩展其应用，这似乎是有益的。与大多数其他肿瘤标志物不同，目前市场上现有的商品化CYFRA 21-1检测方法的可比性良好。应通过国际标准化来维持这种高度的可比性。目前现有的商品化CYFRA 21-1检测的分析性能符合其当前临床应用所产生的要求。然而，尚无关于现场条件下分析性能的数据。CYFRA 21-1作为一种既定的肺癌肿瘤标志物，应纳入外部质量保证计划。
