Grafnetter D, Molinari E, Lonsky L
Institute for Clinical and Experimental Medicine, Prague, Czechaslovakia.
Clin Chim Acta. 1990 Jul;189(1):55-68. doi: 10.1016/0009-8981(90)90235-k.
Apo A-1 and Apo B levels have become increasingly important as a mean of assessing risk and susceptibility to cardiovascular diseases. These proteins are measured routinely in numerous clinical and research laboratories due primarily to the ability to mechanise the immunological assay method and to the ready availability of commercially produced antisera and standards which are often sold in kit form. However, if these variables are to be used to assess the clinical risk of disease reliably, the test methods should have a low degree of imprecision and inaccuracy, to reduce false positive and negative results. The 'normal' and 'pathological' ranges for both proteins also need to be clearly defined. In order to be able to define clinical ranges and establish quality control limits on both a national and international level the inaccuracy and imprecision of the different methods used to assay the parameters need to be established. Since the technical expertise and the equipment and reagents used vary between laboratories, and because there is no internationally recognized calibration material, a survey conducted to establish imprecision and inaccuracy must include many laboratories to take these variations into account. At the WHO Collaborating Lipid Reference Centre, The Institute for Clinical and Experimental Medicine in Prague, Czechoslovakia, we have been involved in the external quality control programme for cholesterol, triglyceride, HDL-cholesterol and thiocyanate methods for more than 15 yr. Although the Centre was originally created as a European Reference Centre, laboratories participating in our quality control scheme now come from Asia, the USA and New Zealand as well as Europe due to their involvement in the large scale population studies like 'MONICA', 'ERICA' and 'CINDI'. In addition we also cooperate with some laboratories expected to join WHO projects and with others running either national or their own research programmes. Due to the increasing need to learn more about the methods used for Apo A-1 and Apo B assays in both research and preventive schemes for cardiovascular diseases, we decided, following the combined IUIS and NHLBI-CDC Apolipoprotein standardization surveys, to arrange for an international survey to determine the precision and relative accuracy of EIA, ELISA, INA, TURB and RID methods. Our survey originally intended to include only European laboratories but the number of participants increased (Table I) and we believe it supplies complementary information to the IUIS-NHLBI-CDC surveys because both research and routine clinical laboratories were included in our survey.
载脂蛋白A-1（Apo A-1）和载脂蛋白B（Apo B）水平作为评估心血管疾病风险和易感性的一种手段，其重要性日益凸显。这些蛋白质在众多临床和研究实验室中常规检测，主要是因为免疫分析方法能够实现机械化，且市售抗血清和标准品随时可得，它们通常以试剂盒形式出售。然而，如果要使用这些变量可靠地评估疾病的临床风险，检测方法应具有低不精密度和低不准确度，以减少假阳性和假阴性结果。这两种蛋白质的“正常”和“病理”范围也需要明确界定。为了能够在国家和国际层面定义临床范围并建立质量控制限，需要确定用于检测这些参数的不同方法的不准确度和不精密度。由于各实验室使用的技术专长、设备和试剂不同，且没有国际认可的校准物质，因此为确定不精密度和不准确度而进行的调查必须包括许多实验室，以考虑到这些差异。在捷克斯洛伐克布拉格的临床与实验医学研究所世界卫生组织脂质参考合作中心，我们参与胆固醇、甘油三酯、高密度脂蛋白胆固醇和硫氰酸盐检测方法的外部质量控制项目已超过15年。尽管该中心最初是作为欧洲参考中心设立的，但由于参与了“莫尼卡”（MONICA）、“埃丽卡”（ERICA）和“辛迪”（CINDI）等大规模人群研究，现在参与我们质量控制计划的实验室来自亚洲、美国、新西兰以及欧洲。此外，我们还与一些预计将参与世界卫生组织项目的实验室以及其他开展国家或自身研究项目的实验室合作。由于越来越需要更多地了解在心血管疾病研究和预防计划中用于检测Apo A-1和Apo B的方法，我们在国际免疫学会（IUIS）和美国国立卫生研究院心肺血液研究所 - 疾病控制与预防中心（NHLBI - CDC）联合载脂蛋白标准化调查之后，决定安排一次国际调查，以确定酶免疫分析（EIA）、酶联免疫吸附测定（ELISA）、免疫比浊法（INA）、透射比浊法（TURB）和免疫扩散法（RID）的精密度和相对准确度。我们的调查最初仅打算包括欧洲实验室，但参与者数量增加了（表一），并且我们认为它为IUIS - NHLBI - CDC调查提供了补充信息，因为我们的调查包括了研究实验室和常规临床实验室。
