Critical Governance Issue of Parathyroid Hormone Assays and its Selection in the Management of Chronic Kidney Disease Mineral and Bone Disorders.

Abstract

Measurement of circulating parathyroid hormone (PTH) levels is essential for optimal management of mineral and bone disorders (MBD) in chronic kidney disease (CKD) patients. There are two major types of PTH assays currently in use: intact parathyroid hormone (i-PTH) and whole PTH (w-PTH) assays. The i-PTH assay is the current standard, and considerable information regarding the management of CKD-MBD has been obtained with this method. However, several limitations have been found with the i-PTH assay. One limitation is that i-PTH assay also measures fragments other than full-length PTH (1-84). Another limitation is the existence of multiple readout methods of the i-PTH assay. The w-PTH assay is theoretically ideal because it exclusively detects full-length PTH (1-84). However, clinical data proving the advantages of w-PTH measurement are not sufficient. For uremic patients, Kidney Disease Improving Global Outcomes suggest that PTH levels should be maintained within approximately two to nine times the upper normal limit of the i-PTH assays. The most critical issue in the evaluation of PTH levels is the lack of definitive PTH assay method. Evidence-based recommendations on clinical management goals of PTH are warranted.