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Test Code NTXSE N-terminal Telopeptide, Serum

Reporting Name

NTX-Telopeptide, S

Useful For

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.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


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

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: 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).


Specimen Minimum Volume

0.1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 28 days
  Refrigerated  24 hours

Reference Values

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

Adult (≥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.

Day(s) and Time(s) Performed

Thursday

Test Classification

This test has been cleared, approved or is exempt by the U.S. 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

82523

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SNTX NTX-Telopeptide, S 21215-9

 

Result ID Test Result Name Result LOINC Value
65558 NTX-Telopeptide, S 21215-9

Clinical Reference

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

The Osteomark N-terminal telopeptide (NTx) serum assay is a competitive-inhibition enzyme-linked immunosorbent assay (ELISA/EIA) 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).(Package insert: Osteomark NTx Serum. Alere Scarborough, Inc; REV 05/2016)

Analytic Time

1 day

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Secondary ID

65558