| Code: | AC-03F1 |
|---|---|
| Certification: |
CE Marked |
| Clinical Area: | Bone Metabolism |
| Type: | Manual |
| Format: | EIA |
| RUO/IVD: | IVD |
| Number of Tests: | 96 (40 samples in duplicate) |
| Sample Type: | Urine |
| Sample Volume: | 15 µL |
| Assay Range: | 0-6750 ng/mL |
Unique Features
- Management of Postmenopausal Osteoporosis
- Prediction of long-term skeletal response to anti-resorptive therapies, e.g. HRT, bisphosphonates
- Increase 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 complete clinical assay panel supporting bone disease management
The Urine CrossLaps® (CTX-I) EIA is an enzyme immunosorbent assay for quantitative determination of degradation products of C-terminal telopeptides of Type-I collagen in human urine.
The Urine CrossLaps® (CTX-I) EIA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in:
Monitoring bone resorption changes of:
Anti-resorptive therapies in postmenopausal women:
- Hormone Replacement Therapies (HRT) with hormones and hormone-like drugs
- Bisphosphonate therapies
Anti-resorptive therapies in individuals diagnosed with osteopenia:
- Hormone Replacement Therapies (HRT) with hormones and hormone-like drugs
- Bisphosphonate therapies.
Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies:
- Hormone Replacement Therapies (HRT) with hormones and hormone-like drugs
- Bisphosphonate
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 Urine CrossLaps® (CTX-I) EIA as has been reported as useful for follow up of anti-resorptive treatment of patients with metabolic bone diseases 1, 2, 3.
Buclin T et al., Bioavailability and biological efficacy of a new oral formulation of salmon calcitonin in healthy volunteers. J Bone Miner Res. 2002 Aug;17(8):1478-85.
Garnero P. et al., Do markers of bone resorption add to bone mineral density and ultrasonographic heel measurement for the prediction of hip fracture in elderly women? The EPIDOS prospective study. Osteoporos Int (1998); 8: 563-569.
Nagase S et al., Bone turnover markers and pharmacokinetics of a new sustained-release formulation of the cathepsin K inhibitor, ONO-5334, in healthy post-menopausal women. J Bone Miner Metab. 2014 Jan 24.
