Test Catalog

Test Id : SNTX

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N-terminal Telopeptide, Serum

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Overview

Test Catalog

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

Monitoring effectiveness of antiresorptive therapy in patients treated for osteoporosis or other metabolic bone disorders

 

As an adjunct in the diagnosis of medical conditions associated with increased bone turnover

 

This test is not useful for screening or diagnosing osteoporosis.

Highlights

Measurement of serum N-terminal telopeptide is helpful for monitoring effectiveness of antiresorptive therapies in patients treated for osteoporosis or other metabolic bone disorders.

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

NTX-Telopeptide, S

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

Collagen Crosslinks

Crosslinked N-telopeptide of Type I Collagen (NTX), Serum

N-Telopeptide, Serum

NTX

Osteomark

Osteoporosis

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: Fasting is preferred due to diurnal variation of markers and food effects.

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. A morning collection from fasting patients is preferred. If not possible, collect the baseline and subsequent specimens under the same circumstances (eg, at same time of day).

2. Centrifuge and aliquot serum into a plastic vial.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.1 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

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 Frozen (preferred) 28 days
Refrigerated 24 hours

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

Monitoring effectiveness of antiresorptive therapy in patients treated for osteoporosis or other metabolic bone disorders

 

As an adjunct in the diagnosis of medical conditions associated with increased bone turnover

 

This test is not useful for screening or diagnosing osteoporosis.

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

Human bone is continuously remodeled through the process of bone formation and resorption. Measurement of bone turnover markers (BTM) in serum or urine serves as an indicator of bone formation or bone resorption cellular activities. BTM are physiologically elevated during childhood, growth, and during fracture healing. The elevations in bone resorption markers and bone formation markers are typically balanced in these circumstances and of no diagnostic value. Bone diseases occur when formation and resorption are uncoupled. In these situations, BTM might serve as predictors of therapy response.

 

Telopeptides of type 1 collagen are the most extensively studied and used bone resorption markers. There are 2 forms depending on the cross-link forming site with collagen, N-terminal telopeptide and C-terminal telopeptide, which are released during collagen degradation.

 

In osteoporosis, a disease characterized by low bone mass and deterioration of bone tissue leading to increase skeletal fragility, measurement of BTM helps to determine treatment efficacy or patient's compliance with therapy. The advantage of measurement of BTM is that changes in response to therapy are observed within 3 to 6 months after therapy initiation, whereas changes in bone mineral density are not observed until 12 to 24 months posttherapy. Other diseases affecting the bone remodeling process, such as hyperthyroidism, all forms of hyperparathyroidism, most forms of osteomalacia and rickets (even if not associated with hyperparathyroidism), hypercalcemia of malignancy, Paget disease, multiple myeloma, bony metastases, as well as various congenital diseases of bone formation and remodeling, can result in accelerated and unbalanced bone turnover and elevation of BTM.

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.

All units are reported in nmol bone collagen equivalents (BCE)

Adult (> or =18 years of age)

 

Males:

5.4-24.2 nmol BCE

 

Females:

Premenopausal: 6.2-19.0 nmol BCE

The target value for postmenopausal adult females undergoing treatment for osteoporosis is the same as the premenopausal reference interval.

Interpretation
Provides information to assist in interpretation of the test results

Elevated levels of N-terminal telopeptide indicate increased bone resorption.

 

A 30% or greater reduction in this resorption marker 3 to 6 months after initiation of therapy indicates a probable adequate therapeutic response.

 

A common target of antiresorptive therapy in the treatment of postmenopausal osteoporosis is to achieve bone markers concentrations within the premenopausal reference range.

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

Serum N-terminal telopeptide (NTx) should not be used for the screening or diagnosis of osteoporosis. In patients with other clinical conditions known to affect bone resorption (eg, cancer metastases to bone), interpretation of serum NTx for monitoring response to osteoporosis therapy might be unreliable.

 

Do not interchange the Osteomark NTx serum assay values with the Osteomark NTx urine assay values, especially when monitoring therapy.

 

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. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.

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

1. Lee J, Vasikaran S: Current recommendations for laboratory testing and use of bone turnover markers in management of osteoporosis. Ann Lab Med. 2012 Mar;32(2):105-112

2. Chopin F, Biver E, Funck-Brentano T, et al: Prognostic interest of bone turnover markers in the management of postmenopausal osteoporosis. Joint Bone Spine. 2012 Jan;79(1):26-31

3. Hlaing TT, Compston JE: Biochemical markers of bone turnover-uses and limitations. Ann Clin Biochem. 2014 Mar;51(Pt 2):189-202

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

The Osteomark N-terminal telopeptide (NTx) serum assay is a competitive-inhibition enzyme-linked immunosorbent assay for quantitative determination of NTx in human serum.

 

NTx epitope is adsorbed onto a 96-well microplate. Diluted samples are added to the microplate wells, followed by a horseradish peroxidase-labeled monoclonal antibody. NTx in the patient sample competes with the NTx epitope in the microplate well for antibody-binding sites. Following a wash step, the amount of labeled antibody bound is measured by colorimetric generation of a peroxide substrate. Absorbance is determined spectrophotometrically, and the NTx concentration calculated using a standard calibration curve. Assay values are reported in nanomoles bone collagen equivalents per liter (nM BCE/L).(Package insert: Osteomark NTx Serum. Alere Scarborough, Inc; REV 05/2016)

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, Thursday

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.

2 to 5 days

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

3 months

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.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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.

82523

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
SNTX NTX-Telopeptide, S 21215-9
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.
65558 NTX-Telopeptide, S 21215-9

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

Test Update Resources

Change Type Effective Date
Test Status - Test Resumed 2022-11-21
Test Status - Test Down 2022-10-28
Test Status - Test Down 2022-10-12
Test Status - Test Down 2022-09-14
Test Status - Test Delay 2022-09-06