Measuring biologically active PTH levels resulting from calcium metabolism disorders
Fujirebio Diagnostics, Inc., a consolidated subsidiary of Miraca Holdings Inc., received FDA clearance of the company’s Lumipulse G whole PTH Assay for testing on its LUMIPULSE G1200 immunoassay platform.
Parathyroid hormone (PTH) is a horomone secreted by the parathyroid glands; which are four small glands located behind the thyroid gland. The hormone regulates metabolism of Calcium and Phosphoric Acid in the body. The measurement of whole Parathyroid Hormone (wPTH 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 assays currently used in most laboratories. The measurement of biologically active PTH (1-84) helps to understand parathyroid function without potential misclassification of the patients.
There is no detectable cross reactivity to 7-84 and other PTH fragments observed with intact PTH (iPTH) assays; since whole PTH measures only the biologically active PTH and is 100 percent specific to whole PTH. Intact PTH can overestimate PTH indicated bone/mineral abnormalities because iPTH assays also detect various PTH fragements.
For Chronic Kidney Disease (CKD) patients not yet on dialysis (stage 3-5), The Clinical Practice Guideline CKD-MBD, Final Version (1/3/2015) recommends the measurement and monitoring of several tests including PTH as part of patient management. A falsely high PTH measurement due to a second generation iPTH test may result in falsely identifying a patient for dialysis.
The Lumipule G whole PTH is also traceable to in-house calibrators that have been assigned to the WHO’s (NIBSC 95/646) standard; 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 CV of ≤4.0 percent.
