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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.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


Patient Preparation:

1. Fasting: 12 hours, required

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 Minimum Volume

0.75 mL

Specimen Stability Information

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

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

Day(s) Performed

Monday through Saturday

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

Cautions

Measurements of bone turnover markers are not useful for the diagnosis of osteoporosis, which should be made on the basis of bone density or clinical history of low-trauma fracture.

 

Osteocalcin is cleared by the kidneys; therefore, elevations may be observed in patients with impaired kidney function without increased bone turnover.

 

Serum osteocalcin may not reflect bone formation in patients treated with the hormone 1,25-dihydroxy vitamin D or those with abnormalities in that hormone since osteocalcin is regulated by 1,25-dihydroxy vitamin D.

 

In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. The presence of antibodies to streptavidin or ruthenium can also rarely occur and may also interfere in this assay. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.

 

In rare cases, interference due to extremely high titers of antibodies to ruthenium or streptavidin can occur.

Report Available

1 to 3 days

Reject Due To

 
Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

NY State Approved

Yes

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Secondary ID

80579