Lack of Comparability of Intact Parathyroid Hormone Measurements among Commercial Assays for End-Stage Renal Disease Patients: Implication for Treatment Decisions

Abstract

Abstract Background: Variability among assays used to measure intact parathyroid hormone (iPTH) is of particular concern because of the routine use of iPTH assay results to guide management of osteodystrophy and calcium metabolism in patients with end-stage renal disease (ESRD). The aim of this study was to determine the extent to which results from commercially available iPTH assays diverge from results obtained with the Nichols Allegro® Intact PTH immunoradiometric assay (IRMA), which was used as evidence in the development of the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines. Methods: We divided EDTA plasma from 46 dialysis patients with ESRD and measured iPTH values with the following commercially available iPTH assays: Nichols’ Allegro iPTH IRMA, Nichols Advantage® iPTH immunochemiluminescent assay (ICMA), Scantibodies’ Total Intact PTH™ IRMA, DiaSorin’s N-tact® iPTH IRMA, DPC’s Coat-A-Count® iPTH IRMA, Roche’s Elecsys® iPTH ICMA, and DSL’s Active® iPTH IRMA. Results: Method comparison showed considerable interassay differences in the measurement of iPTH in ESRD patients. IPTH values assessed by other methods ranged, on average, from 60% to 152% of the Nichols Allegro IRMA values. Of the 6 iPTH assays tested, only the Scantibodies Total Intact PT IRMA (P = 0.7554) and the Roche Elecsys iPTH ICMA (P = 0.1327) resulted in iPTH values not statistically different from those obtained with the Nichols Allegro iPTH IRMA. Conclusions: Noncomparability among iPTH assays remains a distinct problem for the management of ESRD patients. These results should be taken into consideration when determining the course of medical treatment based on measured iPTH concentrations