英文名称 ：(Urine CartiLaps® ELISA)

生产厂商 ：艾狄斯

【预期用途】

本产品仅供科研使用 。尿中II型胶原C端肽酶联免疫吸附分析试剂盒(UrineCartiLaps^® ELISA)检测人尿中II型胶原C端肽(CTX一II)降解产物 。

IDS公司对将试剂用于除上面指定用途以外的任何其他用途的后果不予负责 ，对未按照本手册所示方法而错误使用本试剂不予负责 ；此外 ，对由使用者或第三方根据尿中II型胶原C端肽酶联免疫吸附分析试剂盒的结果所做诊断或结论 ，以及其解释所导致的任何后果不予负责 。

【背景介绍】

软骨结构完整性的损伤是骨关节炎和类风湿关节炎的主要组织学表现。II型胶原蛋白是软骨的主要有机成分 。软骨降解后 ，II型胶原蛋白的片段(CTX-II)释放进入循环系统 ，随后 排入尿中 。尿中的CTX-II片段可由尿中II型胶原C端肽酶联免疫吸附分析试剂盒定量检测 。

据报道 ，尿中II型胶原C端肽酶联免疫吸附分析有利于预测骨关节炎的发展(Reijman 2003, Garnero 2003) 及其它临床和临床前研究(见参考文献) 。

【样本要求】

    建议取第二次晨尿样本 ，也可使用任何时间点的尿样 。尿样在4°C下24小时内稳定 ，长期储存应冷冻存放（<-18°C） 。尿 样至少在10 次冻融周期内保持稳定 。使用前尿样应震荡并沉淀至少30分钟 。

【参考文献】

1. Ceunick F De, Sabatini M, Renoux V, Nanteuil G de, Pastoureau P. Urinary collagen type II C-telopeptide fragments are sensitive markers of matrix metallo-proteinase dependent cartilage degradation in rat adjuvant induced arthritis. J Rheumatol (2003); 30: 1561-1564.
2. Christgau S, Tankó LB, Cloos PAC, Mouritzen U, Christiansen C, Delaissé J-M, Høegh-Andersen P. Suppression of Elevated Cartilage Turnover in Postmenopausal Women and in Ovariectomized Rats by Estrogen and a Selective Estrogen Receptor Modulator (SERM). Submitted.
3. Christgau S, Henrotin Y, Henriksen DB, Rovati LC, Collette J, Bruyere O, Deroisy R, Christiansen C, Reginster JY. Cartilage Degradation In Glucosamine Sulphate Treated Knee Osteoarthritis Patients With Elevated Levels Of Urinary Collagen Type II Ctelopeptide Fragments. Clin Exp Rheumatol. 2004 Jan-Feb;22(1):36-42
4. Christgau S, Garnero P, Fledelius C, Moniz C, Rosenquist C, Ensig M, Gineyts E, Christiansen C, Qvist P. Collagen type II degradation products in urine as an index of cartilage degradation. Bone (2001); 29: 209-215.
5. Forsblad d’Elia H, Christgau S, Mattsson L-Å, Saxne T, Ohlsson C, Nordborg E, Carlsten H. Hormone replacement therapy decreases markers of cartilage and bone metabolism in rheumatoid arthritis. Submitted.
6. Garnero P, Mazières B, Gueguen A, Abbal M, Berdah L, Freiburghaus C, Lequesne M, Nguyen M, Salles J-P, Vignon E, Dougados M. Association of 10 molecular markers of bone, cartilage and synovium with disease activity and joint damage in hip osteoarthritis patients: the ECHODIAH cohort. ACR 2003.
7. Garnero P, Landewé R, Boers M, Verhoeven A, Linden S van der, Christgau S, Heijde D van der, Boonen A, Geusens P. Association of baseline levels of markers of bone and cartilage degradation with long-term progression of joint damage in patients with early rheumatoid arthritis: the COBRA Study. Arthritis & Rheum (2002); 46:2847-2856.
8. Garnero P, Ayral X, Rousseau J-C, Christgau S, Sandell L, Delmas PD, Dougados M. Uncoupling of type II collagen synthesis and degradation predicts progression of joint damage in patients with knee osteoarthritis. Arthritis & Rheum (2002); 46:2613-2624.
9. Garnero P, Gineyts E, Christgau S, Finck B, Delmas PD. Association of baseline levels of urinary glucosyl-galactosyl pyridinoline and type II collagen C-telopeptide with progression of joint destruction in patients with early rheumatoid arthritis. Arthritis & Rheum (2002); 46: 21-30.
10. Garnero P, Christgau S, Delmas PD. The bisphosphonate Zoledronate decreases type II collagen breakdown in patients with Paget’s disease of bone. Bone (2001); 28: 461-464.
11. Garnero P, Piperno M, Gineyts E, Christgau S, Delmas PD, Vignon E. Cross sectional evalsuation of biochemical markers of bone, cartilage, and synovial tissue metabolism in patients with knee osteoarthritis: relations with disease activity and joint damage. Ann Rheum Dis. (2001); 60: 619-26.
12. Høegh-Andersen P, Tankó LB, Andersen T, Vingsbo C, Heegaard A-M, Delaissé J-M, Christgau S. Ovariectomized Rats as a Model of Postmenopausal Osteoarthritis. Validation and Application. Annals of Rheum Dis. (2004); 6(2): R169-80
13. Jensen T, Hansen M, Stoltenberg M, Christgau S, Florescu A, Sommarin Y, Lorenzen I. Biochemical markers of connective tissue metabolism in patients with rheumatoid arthritis. Relationship to disease activity, radiographic outcome and bone mineral density. Submitted.
14. Jung M, Christgau S, Lukoschek M, Henriksen DB, Richter W. Elevated urinary concentration of collagen type II C-telopeptide fragments in patients with osteoarthritis. Pathobiology. (2004); 71(2): 70-6
15. Lehmann HJ, Mouritzen U, Christgau S, Cloos PAC, Christiansen C. The effects of bisphosphonates on CartiLaps: A new marker for cartilage degradation. Annals of Rheumatic Diseases (2002); 61:530-533.
16. Mazières B, Garnero P, Gueguen A, Abbal M, Berdah L, Freiburghaus C, Lequesne M, Nguyen M, Salles J-P, Vignon E, Dougados M. Molecular markers of cartilage breakdown and synovitis are strong independent predictors of structural progression of hip osteoarthritis (OA). the ECHODIAH cohort. ACR 2003.
17. Mouritzen U, Christgau S, Lehmann HJ, Tankó LB, Christiansen C. CartiLaps: A novel marker of Cartilage Degradation. The influence of age, gender, menopause, hormone replacement therapy and bone mass index. Annals Rheum Dis. (2003); 62: 332-336.
18. Roy-Beaudry M, Martel-Pelletier J, Pelletier J-P, M’Barek KN, Christgau S, Shipkolye F, Moldovan F. Entothelin-1 promotes osteoarthritic cartilage degradation via mmp-1 and mmp-13 induction. Arthritis & Rheum (2003); 48:2855-2864.