Test Code LAB1060 Osteocalcin, Serum
Reporting Name
Osteocalcin, SUseful 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
SerumSpecimen 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
TAT: 3 - 5 days
Performing Laboratory
Mayo Clinic Laboratories in RochesterMethod 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 daysReject Due To
Gross hemolysis | Reject |
Gross lipemia | OK |
Gross icterus | OK |