日本血清蛋白标准化项目：国际临床化学和检验医学联合会（IFCC）参考物质（RPPHS/CRM470）的评估及参考区间的建立
Serum protein standardization project in Japan: evaluation of an IFCC reference material (RPPHS/CRM470) and establishment of reference intervals.
作者信息
Itoh Y, Ichihara K, Kanno T, Sugawara T, Ohkubo A, Hirabayashi Y, Igarashi S, Kawano K, Iwata S, Saito K, Kawai T
机构信息
Department of Clinical Pathology, Jichi Medical School, Tochigi-Ken, Japan.
出版信息
J Clin Lab Anal. 1997;11(1):39-44. doi: 10.1002/(sici)1098-2825(1997)11:1<39::aid-jcla7>3.0.co;2-f.
Abstract
Reference preparation for proteins in human serum (RPPHS), also called Certified Reference Material 470 (CRM 470), was prepared by the international Federation of Clinical Chemistry (IFCC) and is intended to serve as a new international plasma protein reference material. It is now being introduced into Japan. RPPHS possesses many excellent properties, including safety, stability, and accuracy in value assignment. Moreover, the physicochemical properties of its proteins are identical to those of fresh serum, giving it immunochemical behavior that is commutable with that of existing reference materials and calibrators in given immunoassays. Reference intervals of 13 serum proteins were determined for the first time using nephelometry and a new working calibrator assigned from RPPHS, which seems certain to play a critical role in the global standardization of specific protein immunoassays.
摘要
人血清蛋白参考制剂（RPPHS），也称为认证参考物质470（CRM 470），由国际临床化学联合会（IFCC）制备，旨在作为一种新的国际血浆蛋白参考物质。目前它正被引入日本。RPPHS具有许多优良特性，包括安全性、稳定性和赋值准确性。此外，其蛋白质的物理化学性质与新鲜血清相同，使其在特定免疫测定中的免疫化学行为与现有参考物质和校准品具有互换性。首次使用比浊法和从RPPHS分配的新工作校准品测定了13种血清蛋白的参考区间，这似乎必将在特定蛋白免疫测定的全球标准化中发挥关键作用。
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