Abstract

Summary

International Federation of Clinical Chemistry and Laboratory Medicine and The International Osteoporosis Foundation Joint Committee on Bone Metabolism believes that the harmonization of PINP assays is an achievable and practical goal.

Introduction

In order to examine the agreement between current commercial assays, a multi-center study was performed for PINP in serum and plasma.

Methods

The automated methods for PINP (Roche Cobas and IDS iSYS) gave similar results. A significant proportional bias was observed between the two automated assays and the Orion radioimmunoassay (RIA) for PINP.

Results

Results from other published studies comparing PINP values among these three assays broadly support our findings. Taken together, these results confirm that harmonized PINP measurements exist between the two automated assays (Roche Cobas and IDS iSYS) when the eGFR is > 30 mL/min/1.73m², but a significant bias exists between the Orion RIA and the two automated assays.

Conclusion

Therefore, in subjects with normal renal function, PINP results reported by the Roche Cobas and IDS iSYS assays are similar and may be used interchangeably, and similar reference intervals and treatment targets could be applied for the two automated assays. Harmonization between the automated assays and the RIA is potentially possible with the use of common calibrators and the development of a reference method for PINP. This should also help ensure that any new commercial assay developed in the future will attain similar results. IOF and IFCC are committed to working together towards this goal with the cooperation of the reagent manufacturing industry.

中文翻译：

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PINP商业化检测的统一；前进的道路

摘要

概要

国际临床化学和检验医学联合会以及国际骨质疏松基金会骨代谢联合委员会认为，统一PINP测定法是可以实现且切实可行的目标。

介绍

为了检查当前商业化验之间的一致性，对血清和血浆中的PINP进行了多中心研究。

方法

PINP的自动化方法（Roche Cobas和IDS iSYS）得出了相似的结果。在两个自动化测定与针对PINP的Orion放射免疫测定（RIA）之间观察到明显的比例偏差。

结果

来自其他已发表研究的结果比较了这三种测定法中的PINP值，广泛支持了我们的发现。综上所述，这些结果证实，当eGFR> 30 mL / min / 1.73m ^2时，两个自动化测定（Roche Cobas和IDS iSYS）之间存在统一的PINP测量值，但是Orion RIA和两个自动化测定之间存在显着偏差分析。

结论

因此，在肾功能正常的受试者中，罗氏科巴斯（Roche Cobas）和IDS iSYS分析报告的PINP结果相似，可以互换使用，相似的参考间隔和治疗靶点可用于两种自动化分析。通过使用常见的校准剂和PINP参考方法的开发，自动化测定和RIA之间的协调可能成为可能。这也应有助于确保将来开发的任何新的商业化检测将获得相似的结果。IOF和IFCC致力于在试剂制造行业的合作下共同努力实现这一目标。