Parathyroid Hormone Standardization Program
Measurement of parathyroid hormone (PTH) along with the respective fragmented versions of this hormone in serum and/or plasma is necessary for the detection, diagnosis, and prevention of calcium/phosphate disorders. PTH is a widely accepted biomarker used to assess skeletal and mineral disorders associated with chronic kidney disease (CKD), referred to as CKD-bone mineral disorders (CKD-MBD). A recent update of the 2017 Kidney Disease Improving Global Outcomes (KDIGO) Guideline for CKD-MBD management emphasized the role of PTH as one of the key biomarkers of this disorder.
Reliable PTH measurement methods are essential for correct disease detection, prevention, and patient care. Clinical practice guidelines that recommend the use of PTH are limited because of considerable method-related variation in results. Research studies reported up to a 4.2-fold difference in measurements depending on the method used. This variation can lead to the misclassification of patients. In addition, it becomes difficult to compare PTH results from different studies and to develop common reference intervals and/or decision levels for treatment.
CDC’s parathyroid hormone standardization program is improving the accuracy of PTH measurements performed in patient care and public health activities. Standardization of PTH will provide an opportunity for accurate diagnostic and improved pathophysiologic insight into CKD-MBD and hypo- and hyperparathyrioidism.
As a first step towards standardization, CDC is developing a reference measurement procedure. To accomplish this, it is employing an ultra-high performance liquid chromatography—high resolution mass spectrometry (UHPLC-HRMS)-based reference method—for PTH and its respective fragments. Also, it is developing serum materials to help in assessing measurement accuracy and to improve the variability of measurement accuracy among laboratories.
Please contact Standardization@cdc.gov with questions about the CDC Parathyroid Hormone Standardization Program.