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Test Code LAB1060 Osteocalcin, Serum

Reporting Name

Osteocalcin, S

Useful For

Monitoring and assessing effectiveness of antiresorptive therapy in patients treated for osteopenia, osteoporosis, Paget disease, or other disorders in which osteocalcin levels are elevated

 

As an adjunct in the diagnosis of medical conditions associated with increased bone turnover, including Paget disease, cancer accompanied by bone metastases, primary hyperparathyroidism, and renal osteodystrophy

 

This test is not useful for the diagnosis of osteoporosis.


Specimen Required


Patient Preparation:

1. Fasting (12 hours)

2. For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.


Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  90 days
  Ambient  72 hours

Day(s) Performed

Monday through Saturday

Seattle Children's Hospital Note:

TAT: 3 - 5 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Method Description

The Roche Osteocalcin assay is a 2-site immunometric (sandwich) assay using electrochemiluminescence detection. Patient specimen, biotinylated monoclonal N-terminal/midregion (N-MID) osteocalcin-specific antibody, and monoclonal N-MID osteocalcin-specific antibody labeled with ruthenium react to form a complex. Streptavidin-coated microparticles act as the solid phase to which the complex binds. Voltage is applied to the electrode, inducing a chemiluminescent emission from the ruthenium, which is then measured against a calibration curve to determine the amount of osteocalcin in the patient specimen.(Package insert: Elecsys N-MID Osteocalcin. Roche Diagnostics; V 1.0 English, 01/2020)

Reference Values

Males

<5 years: 19-75 ng/mL

5-9 years: 21-108 ng/mL

10-15 years: 19-159 ng/mL

16-17 years: 12-114 ng/mL

≥18 years: 9-42 ng/mL

 

Females

<5 years: 14-126 ng/mL

5-9 years: 16-152 ng/mL

10-15 years: 15-151 ng/mL

16-17 years: 9-70 ng/mL

≥18 years: 9-42 ng/mL

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

83937

LOINC Code Information

Test ID Test Order Name Order LOINC Value
OSCAL Osteocalcin, S 2697-1

 

Result ID Test Result Name Result LOINC Value
OSCAL Osteocalcin, S 2697-1

Report Available

1 to 3 days

Reject Due To

 
Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK