IDS iSYS automated intact procollagen-1-N-terminus pro-peptide assay: method evaluation and reference intervals in adults and children
IDS iSYS automated intact procollagen-1-N-terminus pro-peptide assay: method evaluation and reference intervals in adults and children
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DOI：
10.1515/cclm-2012-0531
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发表时间：
2013-10-01
影响因子：
6.8
通讯作者：
Cavalier, Etienne
中科院分区：
文献类型：
--
作者：
Morovat, Alireza;Catchpole, Anthony;Cavalier, Etienne
背景资料：我们进行了技术评估的免疫诊断系统（IDS）的全自动完整的胶原蛋白-I的N-末端前肽（PINP）检测在iPhase平台上，并建立参考区间PINP在成人和儿童。比较血清和血浆值，并评估PINP稳定性。使用828份标本，比较IDS iPhase完整PINP和Roche E170总PINP值。结果：该方法具有良好的回收率和可接受的不精密度。该测定不受黄疸和脂血症的影响，但溶血降低了测量的PINP。血清和血浆值相当。IDS完整值与Roche总PINP值之间存在非线性关系。绝经前和绝经后妇女的PINP值相当，但不同年龄组的妇女之间存在差异。男性血清PINP在45岁以下的年轻人中呈下降趋势，但此后保持稳定。为女性的四个年龄组和男性的两个年龄组建立了单独的参考区间。儿童的数据被划分为四岁年龄组，这些数据显示，PINP很高，直到12岁才有重大的性别差异。此后，值在女性中下降，在13-16岁的年龄组，并进一步在17-20岁的年龄组，而PINP增加，在13-16岁的男孩，随后下降，在17-20 years.Conclusions：IDS免疫PINP完整的分析似乎是可靠的。我们已经建立了性别和年龄相关的参考区间的儿童和成人的基础上，一个相对较大的健康的北欧人口。
Background: We carried out a technical evaluation of the Immunodiagnostic Systems (IDS) automated intact procollagen-I N-terminus propeptide (PINP) assay on the iSYS platform, and established reference intervals for PINP in both adults and children.Methods: Assay imprecision, recovery and interference were studied. Serum and plasma values were compared, and PINP stability was assessed. Using 828 specimens, IDS iSYS intact PINP and Roche E170 total PINP values were compared. Specimens from 597 adults and 485 children and adolescents were used to establish reference intervals for intact PINP.Results: The method demonstrated good recovery and acceptable imprecision. The assay was unaffected by icterus and lipaemia, but haemolysis decreased measured PINP. Serum and plasma values were comparable. There was a non-linear relation between IDS intact and Roche total PINP values. Pre- and post-menopausal women had comparable PINP values, but there was a difference between women of different age groups. Serum PINP in men showed a decline in young age up to 45 years, but remained steady thereafter. Separate reference intervals were established for four age groups in women and for two age groups in men. Data for children were partitioned into four-year age groups, and these showed PINP to be high with no major gender differences until 12 years of age. Thereafter, values in females decreased in 13-16 years age groups and further in 17-20 years age groups, whereas PINP increased in boys of 13-16 years of age with a subsequent decline at 17-20 years.Conclusions: The IDS iSYS PINP intact assay appears to be reliable. We have established gender- and age-related reference intervals for children and adults based on a relatively large healthy North European population.