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Third- or Second-Generation Parathyroid Hormone Assays: A Remaining Debate in the Diagnosis of Primary Hyperparathyroidism

Departments of Hormonal Biology (P.B., F.I.) and Endocrine Surgery (A.C., E.S.), Hôpital Saint-Louis; Department of Rheumatology, Hôpital Cochin (C.C.); and Physiology Laboratory, Hôpital Necker-Enfants Malades (J.-C.S.), Assistance Publique-Hôpitaux de Paris, Paris, France

Address all correspondence and requests for reprints to: Dr. Philippe Boudou, Department of Hormonal Biology, Saint-Louis University Hospital, Assistance Publique-Hôpitaux de Paris, 1 avenue Claude Vellefaux, 75475 Paris Cedex 10, France. E-mail: philippe.boudou{at}sls.aphp.fr.

Background: Since the demonstration that the second-generation PTH assays, also called intact PTH assays, recognize a non-1–84 PTH fragment in addition to the intact 1–84 PTH, new PTH assays defined as third-generation assays have been commercialized. Two previous studies aimed at evaluating whether these third-generation PTH assays improved the diagnostic sensitivity for primary hyperparathyroidism (PHPT), but they yielded opposite results.

Methods: In the present study we compared two second-generation PTH assays (the total intact PTH assay from Scantibodies Laboratory, Inc., and the intact PTH assay from Nichols Institute Diagnostics) with two third-generation assays (the cyclase-activating PTH assay also from Scantibodies Laboratory and the bio-intact PTH assay from Nichols Institute) in a series of 145 consecutive PHPT patients operated in our endocrine surgery department over a 10-month period. A group of 74 healthy subjects served as controls.

Results: The diagnostic sensitivities for PHPT of the total intact, the intact, the cyclase-activating, and the bio-intact assays were 93.8%, 97.3%, 84.2%, and 89.0%, respectively, with 95% confidence intervals in the control groups of 10–46, 11–60, 8.4–34, and 9–41 ng/liter, respectively.

Conclusion: Our findings demonstrate that the diagnostic sensitivities of second- and third-generation PTH assays are similar. Third-generation PTH assays do not therefore improve the diagnosis of elevated serum PTH levels in PHPT, although there are numerical differences among the values.

This article has been cited by other articles:

				N. Ljungdahl, M. Haarhaus, C. Linder, and P. Magnusson Comparison of 3 Third-Generation Assays for Bio-intact Parathyroid Hormone. Clin. Chem., May 1, 2006; 52(5): 903 - 904. [Full Text] [PDF]

				P. Boudou, F. Ibrahim, C. Cormier, E. Sarfati, and J.-C. Souberbielle Unexpected Serum Parathyroid Hormone Profiles in Some Patients with Primary Hyperparathyroidism Clin. Chem., April 1, 2006; 52(4): 757 - 760. [Abstract] [Full Text] [PDF]