| Code: | AC-05F1 |
|---|---|
| Certification: |
FDA Cleared |
| Clinical Area: | Bone Metabolism |
| Type: | Manual |
| Format: | ELISA |
| RUO/IVD: | IVD |
| Number of Tests: | 96 (40 samples in duplicate) |
| Sample Type: | Urine |
| Sample Volume: | 10 μL Pre-diluted (1+3) |
| Assay Range: | 0-40.7 μg/L |
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
- Easy to perform – one step incubation
- A complete clinical assay panel supporting bone disease management
The Urine BETA 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 urine1, 2, 3.
The Urine BETA CrossLaps® (CTX-I) ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in:
A. Monitoring bone resorption changes of
a. Anti-resorptive therapies in postmenopausal women:
- Hormone Replacement Therapies (HRT) with hormones and hormone-like drugs
- Bisphosphonate therapies
B. 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 urine. These fragments can be measured by the Urine BETA CrossLaps® (CTX-I) ELISA.
The Urine BETA CrossLaps® (CTX-I) ELISA is based on two highly specific monoclonal antibodies against the amino acid sequence of EKAHD-β-GGR, where the aspartic acid residue (D) is β-isomerized. In order to obtain a specific signal in the Urine BETA CrossLaps®(CTX-I) ELISA, two chains of EKAHD-β-GGR must be cross-linked. Urine BETA CrossLaps® (CTX-I) ELISA demonstrates a high correlation to corresponding measurements of serum samples in the Serum CrossLaps® (CTX-I) ELISA.
Garnero P et al., Effects of PTH and alendronate on type I collagen isomerization in postmenopausal women with osteoporosis: the PaTH study. J Bone Miner Res. 2008 Sep;23(9):1442-8.
Byrjalsen SD et al., Bone turnover and bone collagen maturation in osteoporosis: effects of antiresorptive therapies. Osteoporos Int. 2008 Mar;19(3):339-48.
Garnero P. The contribution of collagen crosslinks to bone strength. Bonekey Rep. 2012 Sep 19;1:182.
