Test Catalog

Test Id : OSCAL

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Osteocalcin, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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.

Method Name
A short description of the method used to perform the test

Electrochemiluminescence Immunoassay (ECLIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Osteocalcin, S

Aliases
Lists additional common names for a test, as an aid in searching

N-MID Osteocalcin

Osteocalcin

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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 Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

 
Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Osteocalcin, the most important noncollagen protein in bone matrix, accounts for approximately 1% of the total protein in human bone. It is a 49-amino acid protein with a molecular weight of approximately 5800 Da. Osteocalcin contains up to 3 gamma-carboxyglutamic acid residues as a result of posttranslational, vitamin K-dependent enzymatic carboxylation. Its production is dependent upon vitamin K and is stimulated by 1,25 dihydroxy vitamin D.

 

Osteocalcin is produced by osteoblasts and is widely accepted as a marker of bone osteoblastic activity. Osteocalcin, incorporated into the bone matrix, is released into the circulation from the matrix during bone resorption and, hence, is considered a marker of bone turnover rather than a specific marker of bone formation. Osteocalcin levels are increased in metabolic bone diseases with increased bone or osteoid formation, including osteoporosis, osteomalacia, rickets, hyperparathyroidism, renal osteodystrophy, thyrotoxicosis, and in individuals with fractures, acromegaly, and bone metastasis. By means of osteocalcin measurements, it is possible to monitor therapy with antiresorptive agents (bisphosphonates or hormone replacement therapy) in, for example, patients with osteoporosis or hypercalcemia.(1) Decrease in osteocalcin is also observed in some disorders (eg, hypoparathyroidism, hypothyroidism, and growth hormone deficiency).

 

Immunochemical and chromatographic studies have demonstrated considerable heterogeneity for concentrations of circulating osteocalcin in normal individuals and in patients with osteoporosis, chronic kidney failure, and Paget disease. Both intact osteocalcin (amino acids 1-49) and the large N-terminal/midregion (N-MID) fragment (amino acids 1-43) are present in blood. Intact osteocalcin is unstable due to protease cleavage between amino acids 43 and 44. The N-MID fragment, resulting from cleavage, is considerably more stable. This assay detects both the stable N-MID fragment and intact osteocalcin.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

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

> or =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

> or =18 years: 9-42 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

Elevated levels of osteocalcin indicate increased bone turnover.

 

In patients taking antiresorptive agents (bisphosphonates or hormone replacement therapy), a decrease of 20% or less from baseline osteocalcin level (ie, prior to the start of therapy) after 3 to 6 months of therapy suggests effective response to treatment.(2)

 

Patients with diseases, such as hyperparathyroidism, which can be cured, should have a return of osteocalcin levels to the reference range within 3 to 6 months after complete cure.(3)

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Chen JT, Hosoda K, Hasumi K, Ogata E, Shiraki M: Serum N-terminal osteocalcin is a good indicator for estimating responders to hormone replacement therapy in postmenopausal women. J Bone Miner Res. 1996 Nov;11(11):1784-1792

2. Delmas PD, Eastell R, Garnero P, Seibel MJ, Stepan J, Committee of Scientific Advisors of the International Osteoporosis Foundation: The use of biochemical markers of bone turnover in osteoporosis. Committee of Scientific Advisors of the International Osteoporosis Foundation. Osteoporos Int. 2000;11(6):S2-S17

3. Harris SS, Soteriades E, Dawson-Hughes B, Framingham Heart Study, Boston Low-Income Elderly Osteoporosis Study: Secondary hyperparathyroidism and bone turnover in elderly blacks and whites. J Clin Endocrinol Metab. 2001 Aug;86(8):3801-3804

4. Fraser W: Bone and mineral metabolism. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:1422-1491

Method Description
Describes how the test is performed and provides a method-specific reference

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83937

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
OSCAL Osteocalcin, S 2697-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
OSCAL Osteocalcin, S 2697-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports