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Urine BETA CrossLaps® (CTX-I) ELISA

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  • 产品名称:Urine BETA CrossLaps® (CTX-I) ELISA
  • 产品型号:AC-05F1
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简单介绍

品名:Urine BETA CrossLaps® (CTX-I) ELISA 货号:AC-05F1

产品描述
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.

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