Yamauchi Megumi S, Yamane Nobuhisa, Toshimitsu Shoji, Sato Hisatsune, Fujino Tatsuya
Clinical Laboratories, University Hospital of the Ryukyus, Nakagami-gun, Okinawa-pref. 903-0215, Japan.
Rinsho Byori. 2010 Jan;58(1):17-24.
It is well known that most exclusive-typed immunoassay systems are highly precise but are poor in compatibility of their determinations. Thus, it is difficult to compare the determinations among different systems, posing problems when a patient is transferred to different hospitals or when a laboratory intends to change the system currently used. In the study, we tried to approach how to assure inter-immunoassay compatibility among four different systems through determination of the exchanged calibrators. First, determinations of total protein and albumin, and electrophoretic fractionation demonstrated marked differences among calibrators in their protein constituent. Some calibrators were prepared with human sera, but others were with inorganic or non-human albumin-based solution. Regression analysis of calibrators between the indicated concentrations by manufacturers and those actually determined by the different immunoassay systems revealed that; most slopes were closed to 1.0 for alpha-fetoprotein and prostate-specific antigen, but widely dissociated from 0.28 to 4.71 for CA19-9. In evaluation of clinical serum samples, determinations by one immunoassay system were compared with those converted based on a linear regression equation that was obtained by determination of the exchanged calibrators. However, this procedure could not improve compatibility, and positive effects of conversion varied by immunoassay systems combined, and also by test parameters. With these, we concluded that simple conversion of determinations by using the exchanged calibrators and a statistical linear regression could not provide us with the expected compatibility. Thus, standardization of target molecules or probes, and of calibrator constituent were urgent issue to assure inter-immunoassay compatibility.
众所周知，大多数独家型免疫分析系统精度很高，但测定的兼容性较差。因此，不同系统之间的测定结果难以比较，当患者转院或实验室打算更换当前使用的系统时就会出现问题。在本研究中，我们试图通过对交换校准物的测定来探讨如何确保四种不同系统之间的免疫分析兼容性。首先，总蛋白和白蛋白的测定以及电泳分级显示，校准物在蛋白质组成上存在显著差异。一些校准物用人血清制备，而其他的则用无机或基于非人白蛋白的溶液制备。对制造商指定浓度与不同免疫分析系统实际测定浓度之间的校准物进行回归分析发现：甲胎蛋白和前列腺特异性抗原的大多数斜率接近1.0，但CA19-9的斜率从0.28到4.71广泛离散。在临床血清样本评估中，将一种免疫分析系统的测定结果与基于通过交换校准物测定获得的线性回归方程转换后的结果进行比较。然而，该程序无法提高兼容性，转换的积极效果因组合的免疫分析系统以及测试参数而异。基于这些，我们得出结论，使用交换校准物和统计线性回归进行简单的测定转换并不能为我们提供预期的兼容性。因此，目标分子或探针以及校准物组成的标准化是确保免疫分析兼容性的紧迫问题。
