PTH, Intact without Calcium

Test Code
35202


CPT Codes
83970

Preferred Specimen
1.5 mL plasma collected in an EDTA (lavender-top) tube


Minimum Volume
1 mL


Other Acceptable Specimens
2 mL frozen serum


Instructions
Centrifuge and transfer EDTA plasma to a transport tube. Label as PLASMA.


Transport Temperature
Frozen


Specimen Stability
EDTA plasma
Room temperature: 48 hours
Refrigerated: 72 hours
Frozen: 6 months

Serum
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 6 months


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Plasma submitted in sodium heparin (green-top) tube or lithium heparin (green-top) tube


Methodology
Immunoassay (IA)

Setup Schedule
Set up: Sun-Fri; Report available: Same day


Reference Range
Parathyroid Hormone, Intact
<1 Year7-58 pg/mL
1-7 Years12-55 pg/mL
8-18 Years12-71 pg/mL
≥19 Years14-64 pg/mL

Interpretive Guide
 Intact PTHCalcium
Normal ParathyroidNormalNormal
HypoparathyroidismLow or Low NormalLow
Hyperparathyroidism   
  PrimaryNormal or HighHigh
  SecondaryHighNormal or Low
  TertiaryHighHigh
Non-Parathyroid  
  HypercalcemiaLow or Low NormalHigh


Clinical Significance
This test measures intact parathyroid hormone (PTH) levels in blood and may aid in the differential diagnosis of hypocalcemia and hypercalcemia. This test may also be useful in the diagnosis and management of disorders such as hyperparathyroidism, hypoparathyroidism, hypercalcemia of malignancy, or mineral and bone disorder (MBD) due to chronic kidney disease (CKD) [1-4].

PTH measurement is useful for initial evaluation of hypocalcemia, when low or inappropriately normal PTH levels would suggest a lack of adequate PTH secretion (hypoparathyroidism). For differential diagnosis of hypercalcemia, high or inappropriately normal levels of PTH would suggest over-secretion of PTH (hyperparathyroidism or ectopic PTH production), while low levels point to the possibility of hypercalcemia due to a tumor [1,2]. This test may also be helpful in detecting parathyroid disorders caused by chronic calcium and vitamin D deficiency after bariatric surgery [3]. PTH level is recommended as one of the biomarkers to monitor MBD in patients with CKD, starting at CKD stage G3a [4].

Because interpretation of a PTH result depends upon the calcium level, a simultaneous blood calcium test needs to be acquired [1,2].

This assay uses antibodies directed separately against the N-terminal and C-terminal portions of the PTH molecule, in an immunometric "sandwich" format that detects intact molecules. Therefore, this test is not affected by C-terminal fragments, which can accumulate in renal failure.

This immunoassay employs antibodies; therefore, heterophile antibodies in the patient samples may interfere with test results [2].

This assay is not affected by most drugs or supplements, including biotin [2].

The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.

References
1. Endres DB, et al. Mineral and bone metabolism. In: Burtis CA, et al. eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed. Elserier Inc; 2006:1912-1920.
2. Access intact PTH. Instruction for use. Beckman Coulter, Inc; 2020.
3. Wei JH, et al. Obes Surg. 2018;28(3):798-804.
4. Isakova T, et al. Am J Kidney Dis. 2017;70(6):737-751.


Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.