Gent, Belgium – September 5, 2016 – Fujirebio Europe today announced the release of Lumipulse G whole PTH, a 3rd generation assay that is highly useful in the diagnostic of primary hyperparathyroidism, hypoparathyroidism as well as secondary hyperparathyroidism, mainly in nephrology. The Lumipulse G whole PTH is calibrated against the international standard NIBSC WHO 95/646.
Lumipulse G whole PTH is used for the quantitative measurement of whole (1-84) PTH without cross-reaction to 7-84 PTH fragment in human serum and plasma. It uses CLEIA technology through a one-step sandwich immunoassay method and is run on the fully automated series of LUMIPULSE G instruments from Fujirebio.
“Our 3rd generation whole PTH assay measures the PTH (1-84) hormone by using antibodies recognizing both N-terminal and C-terminal fragments and is therefore clinically useful as a whole PTH method.” said Christiaan De Wilde, CEO of Fujirebio Europe. “This assay methodology combined with its calibration against the International WHO standard NIBSC 95/646 means that the new fully automated Lumipulse G wPTH kit offers the most clinically relevant test for the benefit of patients.”
About Parathyroid hormone (PTH)
Parathyroid hormone is a polypeptide composed of 84 amino acids which is secreted from the parathyroid gland and it plays a role of metabolic regulation of both calcium and phosphate.
Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of phosphorus and calcium metabolism.
The main clinical applications for PTH are:
Primary Hyperparathyroidism – Endocrinology
Mineral and bone disorders in Chronic Kidney Disease (see CK-MBD Guideline 2012)
Secondary hyperparathyroidism- Nephrology
Management and treatment of osteoporosis
Hypercalcemia of malignancy
PTH is secreted from the parathyroid gland as full length PTH (whole PTH or PTH (1-84)). Some are broken down in the liver to an intermediate portion which has no biological activity, or to C-terminal fragment PTH.
Since both the intermediate portion and the C-terminal fragment of PTH are metabolized in the kidney, responding to the influence of PTH metabolic abnormalities in the kidney, a significant accumulation can be seen in the body of patients with kidney dysfunctions such as chronic kidney failure. It is therefore very useful to specifically measure the levels of biologically active PTH (1-84) in the blood in order to understand parathyroid ability and to diagnose various calcium metabolic bone diseases.
Blumsohn A. Al Hadan A 2002 Parathyroid Hormone: What Are We Measuring and Does It Matter? Annals of Clinical Biochemistry 39. pp. 169 – 172.
Boudou P. Ibrahaim F. Cormier C. Sarfati E. Souberbielle JC 2006 Unexpected Serum Parathyroid Profiles in Some Patients with Primary Hyperparathyroidism. Clinical Chemistry 52 (4). pp. 1-3.
Stephen Z Fadem & Sharon M Moe 2007, Management of Chronic Kidney Disease-Mineral Bone Disorder. Advances in Chronic Kidney Disease, 14 (1), 44 - 53.
Melamed ML, Eustave JA, Platinga LC et al. Third generation parathyroid hormone assays and All-cause mortality in incident dialysis patients: the CHOICE study. Nephrol Dial Transplant 2008; 23: 1650 – 1658
Moe SM, Drueke TB 2009 KDIGO Clinical Guidelines for the diagnosis, Evaluation, Prevention and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Kidney International, 76, Supplement 113, S1 – S130. ‘Summary and Explanation of the Test’ section has been paraphrased from 3.1, pp. S28-S29.
Segre GV, Niall HD, Habener, JF, Potts Jr. JT 1974 Metabolism of Parathyroid Hormone: Physiologic and Clinical Significance Am J Med 56 (6), 774 -784
Souberbielle JC et al 2006 Inter- Method Variability of PTH Measurement: Implication for the care of CKD patients Kidney International 70 (2), 345 - 350
Fujirebio is a global leader in the field of high quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.
Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.
Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.
Fujirebio is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.
For more information about Fujirebio please visit www.fujirebio-europe.com.