Code:	AC-04F1
Certification:	CE Marked 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:	45 μL (excluding dead volume) 25 μL pre-diluted (1+7)
Assay Range:	0-1600 ng/mL

Product Description

The ALPHA CrossLaps® (CTX-I) ELISA is an enzyme-linked immunosorbent assay for the quantification of non-isomerized fragments of C-terminal telopeptides of Type-I collagen (α CTX-I) in human urine. The ALPHA CrossLaps® (CTX-I) ELISA is intended for use as an indicator of degradation of non-isomerised bone collagen and may be used as an aid in the identification of skeletal metastases in patients with breast and prostate cancer. In addition, the ALPHA CrossLaps®(CTX-I) ELISA may be applied to humans as an aid in the diagnosis of Paget’s disease and the monitoring of anti-resorptive therapy in patients with Paget’s disease.

Scientific Description

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 ALPHA CrossLaps® (CTX-I) ELISA.

The ALPHA CrossLaps® (CTX-I) ELISA is based on one highly specific monoclonal antibody against the amino acid sequence of EKAHDGGR. In order to obtain a specific signal in the ALPHA CrossLaps® (CTX-I) ELISA, two chains of EKAHDGGR must be cross linked.

Publications

Leeming DJ et al., The relative use of eight collagenous and noncollagenous markers for diagnosis of skeletal metastases in breast, prostate, or lung cancer patients. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):32-8.

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.

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Key Features and Values