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PTH Intact

Alternate Name: PTH In_Atellica

SAL Code:

731

CPT:

83970

Loinc:

90741-0

Turn Around Time:

48 hours

Setup:

Mon-Sun

Units:

pg/mL

Department:

Endocrinology

Methodology:

The Atellica IM PTH assay is a 2-site sandwich immunoassay using direct
chemiluminescent technology, which uses constant amounts of 2 anti-human PTH antibodies. The first antibody, in the Lite Reagent, is a mouse monoclonal anti-human PTH (N-terminal) antibody labeled with acridinium ester. The second antibody is a biotinylated mouse monoclonal anti-human PTH (C-terminal) antibody that is bound to streptavidin-coated paramagnetic latex particles in the Solid Phase. A direct relationship
exists between the amount of intact PTH present in the patient sample and the amount of relative light units (RLUs) detected by the system

Specimen Requirements:

Primary Tube:

Lavender

Primary Substance:

Plasma EDTA

Alternate Sample Info:

Lithium heparin plasma, Sodium heparin plasma, Frozen Seperated Serum

Temperature

Period

Stable Ambient:

Serum: 8 hours, EDTA Plasma: 25 hours, Lithium heparin plasma and Sodium heparin plasma: 9 hours

Stable Fridge:

Serum: 8 hours, EDTA Plasma 14 days, Lithium heparin plasma and Sodium heparin plasma; 72 hours

Stable Frozen:

Serum: 1 months, EDTA Plasma: 14 days, Lithium heparin plasma and Sodium heparin plasma: Not recommended

Clinical Info:

The Atellica® IM Intact Parathyroid Hormone (PTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone in human serum and plasma using the Atellica® IM Analyzer. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or disorders of calcium metabolism. This assay can be used intraoperatively.

Test Limitations:

- Interpretation of intact PTH values should always take into account serum calcium results and the interrelationship between these 2 elements in various disorders involving PTH and calcium. It is recommended that the intact PTH results should always be interpreted with caution and with consideration of the overall clinical manifestations even when used in conjunction with calcium values.
- Some overlap of intact PTH values does exist for patients with various parathyroid disorders. Measurement of intact PTH is useful in differentiating between hypercalcemia due to hyperparathyroidism and hypercalcemia of malignancy. However, the assay is not intended as, and should not be relied upon as, a diagnostic indicator of malignancy.
- It is extremely important to ensure that patient samples have been handled and stored correctly. Incorrect handling of samples will result in a loss of intact PTH.
- The Atellica IM PTH assay will detect non-intact PTH, such as PTH fragment (7-84). PTH fragment (7-84) may cause falsely elevated PTH results in patients with abnormal renal function because these patients may have various concentrations of PTH fragment (7-84) in their blood. In patients with abnormal renal function, interpret the PTH result with
caution, and do not make patient management decisions on the PTH result alone. A study of characterized PTH fragments is provided in Lopez et al “Selected Reaction Monitoring-Mass Spectrometric Immunoassay Responsive to Parathyroid Hormone and Related Variants.”
- Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay is designed to minimize interference from heterophilic antibodies. Additional information may be required for diagnosis.

Test Information:

Components: