Parathyroid Hormone Concentrations in Maintenance Hemodialysis: Longitudinal Evaluation of Intact and Biointact Assays.

Rationale & Objective: Management of chronic kidney disease mineral and bone disorder requires parathyroid hormone (PTH) concentrations. "Biointact" PTH immunoassays detect "whole" PTH (wPTH), whereas "intact" immunoassays measure PTH plus PTH fragments (iPTH). We aimed to determine whether longitudinal changes in PTH concentrations can be evaluated using biointact and intact immunoassays alike.

Study Design: Open noninterventional longitudinal cohort study.

Setting & Participants: PTH concentrations were measured quarterly up to 5 times in 102 hemodialysis patients.

Predictors & Tests Compared: Age, sex, phosphate levels, and others as clinical predictors for PTH trend. Tests compared were iPTH immunoassays from Siemens and Roche and wPTH immunoassays from Roche and DiaSorin.

Outcomes: PTH concentration trend; regression equations; test bias.

Analytical Approach: Predictive regression-to-the-mean model for PTH slope; Bland-Altman plots, Passing-Bablok regression, and reference change values for test comparisons.

Results: wPTH concentrations were similar with both immunoassays (wPTH-Roche = 11.7 + 0.97 × wPTH-DiaSorin,  = 0.99; mean ± 1.96 SD bias, 8.2 ± 43.3 pg/mL [17.5% ± 40.9%], by Bland-Altman plots). iPTH-Siemens concentrations were higher than iPTH-Roche concentrations (iPTH-Siemens = -5.4 + 1.33 × iPTH-Roche,  = 0.99; mean ± 1.96 SD bias, 84.0 ± 180.2 pg/mL [21.1% ± 29.8%], by Bland-Altman plots). iPTH-Roche and iPTH-Siemens concentrations were 2- and 2.5-fold higher than wPTH concentrations, respectively. Full agreement among all 4 immunoassays in detecting both significant and insignificant changes in PTH concentrations, upward or downward from one quarter to the next, was reached in 87% of consecutive measurements. In a predictive model, baseline PTH concentrations > 199 pg/mL (wPTH-Roche), 204 pg/mL (wPTH-DiaSorin), 386 pg/mL (iPTH-Roche), and 417 pg/mL (iPTH-Siemens) correctly predicted declining PTH concentration trend in 62% to 68% of patients, but age, sex, hemodialysis vintage, and calcium and phosphate levels were no significant predictors.

Limitations: Limited number of immunoassays, only 59 patients attended all quarterly samplings.

Conclusions: wPTH-Roche and wPTH-DiaSorin concentrations were similar, while iPTH was higher than wPTH concentrations. The iPTH-Siemens immunoassay is either higher calibrated or detects more fragments than iPTH-Roche. However, longitudinal PTH concentration changes largely coincided with all tested immunoassays.