Switching between parathormone (PTH) assays: the impact on the diagnosis of renal osteodystrophy

Abstract

Background: Clinical guidelines for decision-making in chronic kidney disease (CKD) consider parathormone (PTH) levels. The measured PTH values differ if novel full length PTH(1-84) assays are used instead of earlier intact iPTH assays. In this study we analyzed how the classification of CKD patients alters when iPTH assays are switched to PTH(1-84) assays. Methods: Plasma samples were collected prior to dialysis sessions from 110 consecutive CKD patients on maintenance hemodialysis. PTH levels were determined with iPTH assays (Elecsys, Architect and DiaSorin Liaison N-tact) and PTH(1-84) assays (Elecsys and Liaison). Using KDIGO guidelines patients were classified as being below, above and in the recommended target range (RTR) of PTH. The results of classification with different assays were evaluated and, a novel calculation method of RTR was implemented. Results: The prevalence of patients with PTH in RTR is comparable with each assay, but the individual patients differed. PTH(1-84) Elecsys and Liaison assays classified more patients as being below RTR than iPTH Elecsys and Architect but not Liaison N-tact assay (27.3%, 22.7% vs. 41%, 31.8%, and 36.4%, respectively). In turn, PTH(1-84) Elecsys and Liaison assays identified less CKD patients with PTH above the RTR than iPTH except N-tact assays (6.4%, 10% vs. 16.3%, 19%, and 6.3%, respectively). Using our calculation method, our discrimination values for PTH(1-84) assays to achieve classification identical to that with iPTH Elecsys were lower than those recommended by the manufacturer. Conclusions: Current guidelines for the treatment of secondary hyperparathyroidism in CKD should consider the type of assays used for PTH measurement. Each laboratory should assess its own RTR for PTH tests to achieve comparable classification. The presented calculation is simple, it mimics an everyday situation, switching from one assay to another one, and provides useful RTR values for PTH tests.