Beta-CrossLaps (Beta-CTx), Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
An aid in monitoring antiresorptive therapies (eg, bisphosphonates and hormone replacement therapy) in postmenopausal women treated for osteoporosis and individuals diagnosed with osteopenia
An adjunct in the diagnosis of medical conditions associated with increased bone turnover
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Beta-CrossLaps (B-CTx), S
C-terminal collagen crosslinks
Carboxy terminal collagen crosslinks
C-terminal collagen crosslinks
Carboxy terminal collagen crosslinks
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Fasting. Draw specimen prior to 10 a.m.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Frozen (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Human bone is continuously remodeled through a process of bone formation and resorption. Approximately 90% of the organic matrix of bone is type I collagen, a helical protein that is crosslinked at the N- and C-terminal ends of the molecule. During bone resorption, osteoclasts secrete a mixture of acid and neutral proteases that degrade the collagen fibrils into molecular fragments including C-terminal telopeptide (CTx). As bone ages, the alpha form of aspartic acid present in CTx converts to the beta form (beta-CTx). Beta-CTx is released into the bloodstream during bone resorption and serves as a specific marker for the degradation of mature type I collagen. Elevated serum concentrations of beta-CTx have been reported in patients with increased bone resorption.
Bone turnover markers are physiologically elevated during childhood, growth, and fracture healing. The elevations in bone resorption markers and bone formation markers are typically balanced in these circumstances and are of no diagnostic value. By contrast, bone turnover markers may be useful when the bone remodeling process is unbalanced. Abnormalities in the process of bone remodeling can result in changes in skeletal mass and shape. Many diseases, in particular hyperthyroidism, all forms of hyperparathyroidism, most forms of osteomalacia and rickets (even if not associated with hyperparathyroidism), hypercalcemia of malignancy, Pagets disease, multiple myeloma, and bone metastases, as well as various congenital diseases of bone formation and remodeling, can result in accelerated and unbalanced bone turnover. Unbalanced bone turnover is also found in age-related and postmenopausal osteopenia and osteoporosis.
Disease-associated bone turnover abnormalities should normalize in response to effective therapeutic interventions, which can be monitored by measurement of serum and urine bone resorption markers.
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.
<18 years: not established
18-30 years: 155-873 pg/mL
31-50 years: 93-630 pg/mL
51-70 years: 35-836 pg/mL
>70 years: not established
<18 years: not established
Premenopausal: 25-573 pg/mL
Postmenopausal: 104-1,008 pg/mL
Elevated levels of beta-CTx indicate increased bone resorption. Increased levels are associated with osteoporosis, osteopenia, Paget disease, hyperthyroidism, and hyperparathyroidism.
In patients taking antiresorptive agents (bisphosphonates or hormone replacement therapy), a decrease of > or =25% from baseline beta-CTx levels (ie, prior to the start of therapy) 3 to 6 months after initiation of therapy indicates an adequate therapeutic response.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Reduced renal function may lead to reduced urinary excretion of beta-CTx and a consequent increase in the apparent serum beta-CTx concentration.
In patients receiving therapy with high doses of biotin (ie, >5 mg/day), wait at least 8 hours after the last biotin administration before drawing a specimen, to avoid assay interference from the biotin.
As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from specimens taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes.
In rare cases, interference due to extremely high titers of antibodies to ruthenium or streptavidin can occur.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Christgau S, Bitsch-Jensen O, Hanover Bjarnason N, et al: Serum CrossLaps for monitoring the response in individuals undergoing antiresorptive therapy. Bone 2000 May;26(5):505-511
2. Garnero P, Borel O, Delmas PD: Evaluation of a fully automated serum assay for C-terminal cross-linking telopeptide of type I collagen in osteoporosis. Clin Chem. 2001 Apr;47(4):694-702
3. Delmas PD, Eastell R, Garnero P, et al: The use of biochemical markers of bone turnover in osteoporosis. Committee of Scientific Advisors of the International Osteoporosis Foundation. Osteoporo Int 2000;11:S2-S17
Method Description Describes how the test is performed and provides a method-specific reference
Testing is performed using the Roche Cobas 6000 e601 analyzer and the Roche Beta-CrossLaps assay, a 2-site immunometric (sandwich) assay using electrochemiluminescence detection. Patient specimen, biotinylated monoclonal beta-CrossLaps-specific antibody, and monoclonal beta-CrossLaps-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 beta-CrossLaps in the patient specimen. This assay is specific for crosslinked isomerized type I collagen fragments, independent of the nature of the crosslink (eg, pyrrole, pyridinolines). The assay specificity is guaranteed through the use of 2 monoclonal antibodies, each recognizing linear beta-8AA octapeptides (EKAHD-beta-GGR). The assay therefore quantifies all type I collagen degradation fragments that contain the isomerized octapeptide beta-8AA twice (beta-CTx).(Package insert: Beta-CrossLaps Roche Cobas. Roche Diagnostics, Indianapolis, IN 2010-08, V3)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 5 a.m.-12 a.m., Saturday; 6 a.m.-6 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved 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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|CTX||Beta-CrossLaps (B-CTx), S||41171-0|