Naka H, Nogami K, Sekine S
Central Clinical Laboratories, Mitsui Memorial Hospital, Tokyo.
Rinsho Byori. 1991 Feb;39(2):115-23.
We have reviewed the current methods of determining serum and urine myoglobin. Qualitative determination of urine myoglobin has been possible for over 20 years, but the quantitative determination is a recent development. Between 1963 (spectrophotometry) and 1978 (radioimmunoassay, RIA), efforts have been made to develop a more sensitive determination method. The RIA method thus developed has a sensitivity as high as 1 ng/ml. Such methods are valuable in the diagnosis of acute myocardial infarction. Recently, simple, rapid, and non-isotopic method such as enzyme immunoassay (EIA) and latex agglutination test have been developed and made rapid determination possible. We applied the "Mb-latex [Seiken]", one such latex agglutination method to the TBA-30 R single-multi type automated analyzer. We obtained good results in the fundamental study such as in precision and accuracy. The reference ranges obtained using serum and urine samples corresponded to the values reported by others with the exception of the lower limit of the ranges. Proficiency testing data using the same reagents and same samples at five laboratories revealed some systematic biases. The reasons for such interlaboratory differences is not clear. However, these systematic biases may be due to the type of equipment, the type of calibration procedure and others including reagents and standard solutions. We are continuing our effort to improve the reliability of interlaboratory data.
我们回顾了目前测定血清和尿肌红蛋白的方法。尿肌红蛋白的定性测定已有20多年历史,但定量测定是最近才发展起来的。在1963年(分光光度法)至1978年(放射免疫测定法,RIA)期间,人们努力开发更灵敏的测定方法。由此开发的RIA方法灵敏度高达1 ng/ml。这些方法在急性心肌梗死的诊断中很有价值。最近,已开发出简单、快速且非同位素的方法,如酶免疫测定法(EIA)和乳胶凝集试验,使得快速测定成为可能。我们将其中一种乳胶凝集方法“Mb-乳胶[Seiken]”应用于TBA-30 R单多类型自动分析仪。我们在精密度和准确性等基础研究中取得了良好结果。使用血清和尿样获得的参考范围除范围下限外,与其他人报告的值相符。在五个实验室使用相同试剂和相同样品进行的能力验证数据显示存在一些系统偏差。这种实验室间差异的原因尚不清楚。然而,这些系统偏差可能是由于设备类型、校准程序类型以及包括试剂和标准溶液在内的其他因素造成的。我们正在继续努力提高实验室间数据的可靠性。