Berg K
Institute of Medical Genetics, University of Oslo, Norway.
Clin Genet. 1994 Jul;46(1 Spec No):57-62. doi: 10.1111/j.1399-0004.1994.tb04203.x.
A small number of recent studies have reportedly failed to detect the well-established association between a high Lp(a) lipoprotein level and coronary heart disease (CHD). This has made some workers question the importance of a high Lp(a) lipoprotein level as a CHD risk factor. However, serious problems with some of the commercially available test kits, inadequate test techniques or failure to consider the lability of the Lp(a) lipoprotein particle are more plausible explanations of the confounding results. The problems with some of the commercially available test kits include lack of standardization and validation; risk of cross-reactivity with plasminogen or other serum proteins; failure to consider potential problems when measuring samples with varying length of the Lp(a) polypeptide chain (i.e. failure to cope with the isoform variation); non-divulgence of contents of test reagents; and pretreatments of samples that drastically change the Lp(a) lipoprotein particles from their native state. Any test system should be validated at the scientific level before it is assumed to provide correct measurements of Lp(a) lipoprotein level in serum. New test kits should be safely anchored in validation in one of the research laboratories active in the area, before they are put on the market. As new batches are produced, the quality of every new batch of test kits should be monitored on a long-term basis in collaboration with a research laboratory.
据报道，最近有少数研究未能检测到高脂蛋白(a)[Lp(a)]水平与冠心病（CHD）之间已被充分证实的关联。这使得一些研究人员质疑高Lp(a)脂蛋白水平作为冠心病危险因素的重要性。然而，一些市售检测试剂盒存在严重问题、检测技术不完善或未考虑Lp(a)脂蛋白颗粒的不稳定性，这些更有可能是造成结果混淆的原因。一些市售检测试剂盒存在的问题包括缺乏标准化和验证；与纤溶酶原或其他血清蛋白发生交叉反应的风险；在测量具有不同Lp(a)多肽链长度的样本时未考虑潜在问题（即无法应对异构体变异）；检测试剂内容不公开；以及样本预处理会使Lp(a)脂蛋白颗粒从天然状态发生巨大变化。任何检测系统在被假定能正确测量血清中Lp(a)脂蛋白水平之前，都应在科学层面进行验证。新的检测试剂盒在投放市场之前，应在该领域活跃的研究实验室之一进行安全的验证。随着新批次的生产，每一批新检测试剂盒的质量都应与研究实验室合作进行长期监测。
