Ann Lab Med 2017; 37(5): 381-387  
Comparison of Intact PTH and Bio-Intact PTH Assays Among Non-Dialysis Dependent Chronic Kidney Disease Patients
Yael Einbinder, M.D.1,2, Sydney Benchetrit, M.D.1,2, Eliezer Golan, M.D.1,2, and Tali Zitman-Gal, Ph.D.1,2
Department of Nephrology and Hypertension1, Meir Medical Center, Kfar Saba; Sackler Faculty of Medicine2, Tel Aviv University, Tel Aviv, Israel
Correspondence to: Tali Zitman-Gal
Department of Nephrology and Hypertension, Meir Medical Center, Kfar Saba 44281, Israel
Tel: +972-9-7472401 Fax: +972-9-7416918 E-mail:
Received: December 18, 2016; Revised: March 27, 2017; Accepted: June 2, 2017; Published online: September 1, 2017.
© The Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: The third-generation bio-intact parathyroid hormone (PTH) (1–84) assay was designed to overcome problems associated with the detection of C-terminal fragments by the second-generation intact PTH assay. The two assays have been compared primarily among dialysis populations. The present study evaluated the correlations and differences between these two PTH assays among patients with chronic kidney disease (CKD) stages 3 to 5 not yet on dialysis.
Methods: Blood samples were collected from 98 patients with CKD stages 3 to 5. PTH concentrations were measured simultaneously by using the second-generation - PTH intact-STAT and third-generation bio-intact 1–84 PTH assays. Other serum biomarkers of bone mineral disorders were also assessed. CKD stage was calculated by using the CKD-Epidemiology Collaboration (EPI) formula.
Results: Serum bio-intact PTH concentrations were strongly correlated but significantly lower than the intact PTH concentrations (r=0.963, P<0.0001). This finding was consistent among CKD stages 3 to 5. PTH concentrations by both assays (intact and bio-intact PTH) positively correlated with urea (r=0.523, r=0.504; P=0.002, respectively), phosphorus (r=0.532, r=0.521; P<0.0001, respectively) and negatively correlated with blood calcium (r=–0.435, r=–0.476; P<0.0001, respectively), 25(OH) vitamin D, (r=–0.319, r=–0.353; respectively, P<0.0001) and the estimated glomerular filtration rate (r=–0.717, r=–0.688; P<0.0001, respectively).
Conclusions: Among patients with CKD stages 3 to 5 not on dialysis, the bio-intact PTH assay detected significantly lower PTH concentrations compared with intact PTH assay. Additional studies that correlate the diagnosis and management of CKD mineral and bone disorders with bone histomorphometric findings are needed to determine whether bio-intact PTH assay results are better surrogate markers in these early stages of CKD.
Keywords: Chronic kidney disease, PTH, Secondary hyperparathyroidism, Intact-PTH, Bio-intact PTH, Comparison

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