At a glance
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. This page provides information on how laboratories can do this.
Overview
PTH is a widely accepted biomarker used to assess skeletal and mineral disorders connected to 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 measurements essential
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 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 cause patients' health issues to be misclassified. In addition, the variation makes it difficult to compare PTH results from different studies and develop common reference intervals and/or decision levels for treatment.
Improved accuracy
CDC's parathyroid hormone standardization program improves the accuracy of PTH measurements taken in patient care and public health. Standardization of PTH can provide an opportunity for accurate diagnostic and improved pathophysiologic insight into CKD-MBD and hypo- and hyperparathyrioidism.
To help with standardization, CDC is developing a reference measurement procedure that employs an ultra-high performance liquid chromatography—high resolution mass spectrometry (UHPLC-HRMS)-based reference method—for PTH and its respective fragments. CDC also is developing serum materials to help assess measurement accuracy and improve variability among laboratories.
Please contact Standardization@cdc.gov with questions about the CDC Parathyroid Hormone Standardization Program.