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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协调 PINP 的商业化验；前进的道路。

国际临床化学和检验医学联合会和国际骨质疏松症基金会骨代谢联合委员会认为，统一 PINP 检测是一个可实现且切实可行的目标。引言 为了检验当前商业化验之间的一致性，对血清和血浆中的 PINP 进行了一项多中心研究。方法 PINP 的自动化方法（Roche Cobas 和 IDS iSYS）给出了类似的结果。在 PINP 的两种自动测定和 Orion 放射免疫测定 (RIA) 之间观察到显着的比例偏差。结果 其他已发表研究比较这三种检测方法中的 PINP 值的结果广泛支持我们的发现。综合起来，这些结果证实，当 eGFR > 30 mL/min/1.73m2 时，两种自动测定（Roche Cobas 和 IDS iSYS）之间存在协调的 PINP 测量，但 Orion RIA 和两种自动测定之间存在显着偏差。结 通过使用通用校准器和开发 PINP 参考方法，自动化检测和 RIA 之间的协调可能是可能的。这也应该有助于确保未来开发的任何新的商业化验都将获得类似的结果。