Fujirebio Diagnostics, Malvern, Pa, has received FDA clearance for use of its new Lumipulse G whole PTH assay on the company’s Lumipulse G1200 immunoassay platform.

Parathyroid hormone (PTH) is secreted by the four small parathyroid glands, which are located behind the thyroid. PTH regulates the metabolism of calcium and phosphoric acid in the body. The measurement of whole PTH (or PTH 1-84) using the Lumipulse G whole PTH assay can be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from calcium metabolism disorders.

The Lumipulse G whole PTH assay has a significant benefit over prior generation intact PTH (iPTH) assays because the ability to measure biologically active PTH helps to understand parathyroid function without potential misclassification of the patients. There is no detectable cross-reactivity to PTH 7-84 or other PTH fragments that may be seen with iPTH assays; the whole PTH assay measures only biologically active PTH and is 100% specific. Intact PTH can overestimate PTH-indicated bone or mineral abnormalities because iPTH assays also detect various PTH fragments.1

Clinical practice guidelines for chronic kidney disease and mineral and bone disorder recommend the measurement and monitoring of several tests, including PTH, for chronic kidney disease patients not yet on dialysis. A falsely high PTH measurement due to a second-generation iPTH test could result in falsely identifying a patient for dialysis. The Lumipule G whole PTH assay is also traceable to in-house calibrators that have been assigned to the World Health Organization standard (UK National Institute for Biological Standards and Control 95/646), while iPTH assays are not standardized and their values can vary by manufacturer.

The Lumipulse G whole PTH assay on the Lumipulse G1200 analyzer offers a fully automated assay with a reaction time of just 30 minutes, using a single test cartridge design for reagent stability, efficiency, and testing flexibility. The assay has demonstrated excellent precision with a coefficient of variance ≤4.0%.

“The Lumipulse G whole PTH assay is an innovative next-generation assay to help diagnose calcium metabolism disorders, and to help monitor and adjust treatment of CKD patients,” says Matthew Bell, vice president of sales and marketing at Fujirebio US.

For more information, visit Fujirebio Diagnostics.


  1. Kazama JJ, Omori K, Higuchi N, et al. Intact PTH assay overestimates true 1-84 PTH levels after maxacalcitol therapy in dialysis patients with secondary hyperparathyroidism. Nephrol Dial Transplant. 2004;19(4):892–897.