PathWest Laboratory Medicine, Fiona Stanley Hospital, Murdoch, WA, Australia.
Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.
Osteoporos Int. 2020 Mar;31(3):409-412. doi: 10.1007/s00198-020-05310-6. Epub 2020 Jan 23.
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.
In order to examine the agreement between current commercial assays, a multi-center study was performed for PINP in serum and plasma.
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 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/1.73m, but a significant bias exists between the Orion RIA and the two automated assays.
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.
国际临床化学和实验室医学联合会和国际骨质疏松基金会骨代谢联合委员会认为，PINP 检测的协调一致是一个可行且实际的目标。
为了检验当前商业检测方法之间的一致性，对血清和血浆中的 PINP 进行了多中心研究。
用于 PINP 的自动化方法（罗氏 Cobas 和 IDS iSYS）给出了相似的结果。在这两种自动化检测方法和 Orion 放射免疫测定法（RIA）之间观察到 PINP 存在显著的比例偏差。
来自其他发表的研究比较了这三种检测方法之间的 PINP 值，这些结果广泛支持我们的发现。综上所述，这些结果证实，当 eGFR>30 mL/min/1.73m 时，两种自动化检测方法（罗氏 Cobas 和 IDS iSYS）之间存在协调一致的 PINP 测量，但在 Orion RIA 和两种自动化检测方法之间存在显著偏差。
因此，在肾功能正常的受试者中，罗氏 Cobas 和 IDS iSYS 检测方法报告的 PINP 结果相似，可以互换使用，并且可以对两种自动化检测方法应用类似的参考区间和治疗目标。通过使用通用校准品并开发 PINP 的参考方法，自动化检测方法和 RIA 之间的协调是有可能的。这也有助于确保未来开发的任何新商业检测方法都能获得类似的结果。IOF 和 IFCC 致力于与试剂制造行业合作，共同实现这一目标。
