| Code: | AC-02F1 |
|---|---|
| Certification: |
CE Marked |
| Clinical Area: | Bone Metabolism |
| Type: | Manual |
| Format: | ELISA |
| RUO/IVD: | IVD |
| Number of Tests: | 96 (40 samples in duplicate) |
| Sample Type: | Serum or Plasma |
| Sample Volume: | 50 μL |
| Assay Range: | 0-3.380 ng/mL |
Unique Features
- Management of Postmenopausal Osteoporosis
- Prediction of long-term skeletal response to anti-resorptive therapies, e.g. HRT, bisphosphonates
- Increase in patient motivation and compliance
- Assessment of Bone Resorption in Patients
- With metabolic bone disease, e.g. hyperparathyroidism, Paget´s disease, osteodystrophy
- Receiving prolonged glucocorticoid therapy
- A reference marker for osteoporosis management as indicated by IOF, IFCC and NBHA
- Easy to perform – one step incubation
- Excellent correlation with automated methods
- A complete assay panel supporting bone disease management
The Serum CrossLaps® (CTX-I) ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type I collagen in human serum and plasma.
The Serum CrossLaps® (CTX-I) ELISA assay is intended for in-vitro diagnostic use as an indication of human bone resorption and may be used as an aid in:
1. Monitoring bone resorption changes of:
a) Anti-resorptive therapies in postmenopausal women1, 2:
- Hormone Replacement Therapies (HRT) with hormones and hormone-like drugs
- Bisphosphonate therapies
b) Anti-resorptive therapies in individuals diagnosed with osteopaenia:
- Hormone Replacement Therapies (HRT) with hormones and hormone-like drugs
- Bisphosphonate therapies
2. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing
anti-resorptive therapies:
a) Hormone Replacement Therapies (HRT) with hormones and hormone-like drugs
b) Bisphosphonate therapies
Type I collagen accounts for more than 90% of the organic matrix of bone and is synthesised primarily in bone. During renewal of the skeleton, Type I collagen is degraded and small peptide fragments are excreted into the bloodstream. Serum levels of these degradation products, such as CTX-I, are highly correlated with the bone turnover rate and allow an assessment of the rate of bone resorption.
The Serum CrossLaps® (CTX-I) ELISA is based on two highly specific monoclonal antibodies against the amino acid sequence of EKAHD-ß-GGR, where the aspartic acid residue (D) is ß-isomerised. In order to obtain a specific signal in the Serum CrossLaps® (CTX-I) ELISA, two chains of EKAHD-ß-GGR must be cross-linked.
As of late 2010, IOF and IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) recommend the serum CTX-I as a bone resorption marker for use in observational and intervention studies, in order to compare the performance of alternatives and to widen international experience of the application of bone markers to clinical medicine3.
McClung MR et al., Effect of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial. Osteoporos Int. 2013 Jan;24(1):227-35
Stoch SA et al., Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics–results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54
Vasikaran SD et al. Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int. 2010; 22(2):391-420.
