International Federation of Clinical Chemistry standardization project for measurements of apolipoproteins A-I and B. II. Evaluation and selection of candidate reference materials.
International Federation of Clinical Chemistry standardization project for measurements of apolipoproteins A-I and B. II. Evaluation and selection of candidate reference materials.
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DOI：
10.1093/clinchem/38.5.658
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发表时间：
1992-05
影响因子：
9.3
通讯作者：
J. J. Albers-J.;S. Marcovina;H. Kennedy
中科院分区：
文献类型：
--
作者：
J. J. Albers-J.;S. Marcovina;H. Kennedy
用于测量载脂蛋白 (apo) A-I 和 apo B 的测试系统标准化的国际合作研究的第一阶段表明，如果使用合适的通用参考材料来校准不同的系统，则可以实现 apo A-I 和 apo B 测量的一致性。第二阶段的目标是评估第一阶段选定的候选参考材料的线性度、平行度或比例性，并确定它们是否可以被提议作为国际参考材料。我们使用 37 个 apo A-I 测试系统和 38 个 apo B 测试系统评估了拟议的参考材料，涉及 23 个制造商和 5 个研究实验室。针对apo A-I，提出了两种冻干制剂，Behringwerke AG 的SP1 和Daiichi Pure Chemicals Co. 的SP2，针对apo B 提出了两种液体制剂，Behringwerke AG 的SP3 和Reagents applications 的SP4。将候选参考材料的线性与分配给所有参与者的冷冻血清池或临时血清参考材料的线性以及每个参与者制备的新鲜血清池的线性进行比较。 SP1 和 SP3 表现出与新鲜冷冻血清库相似的线性和平行性，并且实验室间 CV 小于或类似于在正常血脂血清样品中获得的 CV（载脂蛋白 A-I 约为 6%，载脂蛋白 B 约为 7%）。
The first phase of an international collaborative study for standardization of test systems for measuring apolipoprotein (apo) A-I and apo B demonstrated that uniformity of apo A-I and apo B measurements can be achieved if suitable common reference materials are used to calibrate the different systems. The objective of the second phase was to evaluate the linearity and parallelism or proportionality of the candidate reference materials selected in phase one and to determine whether any of them could be proposed as international reference materials. We evaluated the proposed reference materials with 37 test systems for apo A-I and 38 for apo B, involving 23 manufacturers and five research laboratories. Two lyophilized preparations were proposed for apo A-I, SP1 from Behringwerke AG and SP2 from Daiichi Pure Chemicals Co., and two liquid preparations were proposed for apo B, SP3 from Behringwerke AG and SP4 from Reagents Applications. The linearity of the candidate reference materials was compared with the linearity of a frozen serum pool or interim serum reference material distributed to all the participants and with that of a fresh serum pool prepared by each participant. SP1 and SP3 exhibited linearity and parallelism similar to that of the fresh frozen serum pool and had among-laboratory CVs less than or similar to those obtained on normolipidemic serum samples (approximately 6% for apo A-I and approximately 7% for apo B).