骨代謝

心血管疾病

氧化應激

Osteoprotegerin

BNP Fragment*

MDA-oxLDL*

Free soluble Rankl

proANP

Peroxides

Dickkopf-1*

NT-proCNP

Autoantibodies against oxLDL

Sclerostin*

Big Endothelin

Cathepsin K*

Endothelin

Endostatin*

骨質酥松癥、關節炎、骨代謝紊亂、腫瘤誘導的骨病

冠狀動脈疾病、shen病、癌癥

冠狀動脈疾病、shen病、動脈硬化

骨代謝

應用

Osteoprotegerin （OPG）

心血管疾病評價的標記物

Free soluble Rankl (sRankl)

可控制孕酮水平變化導致的乳腺癌及抑制骨腫瘤細胞的進一步惡化。

Dickkopf-1(DKK-1)

減輕病人對骨髓瘤治療的MM應答

Sclerostin

Sclerostin 抗體治療，促進骨質形成。

Cathepsin K

心血管疾病

應用

BNP Fragment（8-29）

心血管疾病預后治療檢測的標記物

proANP（1-98）

抗腫瘤治療的新靶點，可預測慢性心衰竭的患者的生存率。

NT-proCNP

可預測創傷引起的敗血癥發病率

Big Endothelin（1-38）

ET-A受體拮抗劑，用于改善冠脈內皮功能。

ET-B 受體，腫瘤免疫治療的靶點

Endothelin（1-21）

Endostatin

內源性的血管生成抑制劑，是慢性shen臟病人微血管檢測的可能的標記物

氧化應激

應用

MDA-oxLDL（MDA-oxLDL）

與代謝綜合征和冠心病風險檢測相關，是急性心肌梗死的影響因子。

Autoantibodies against oxLDL(oLAB)

評價藥物對氧化低密度脂蛋白自身抗體產生的相關效應。

Peroxides

骨代謝標記物

在絕經婦女、骨固定引起的骨質流失患者、多重骨髓瘤患者Sclerostin水平顯著升高。經甲狀旁腺素（PTH）和雌性激素持續治療后，血清Sclerostin水平降低。隨著Sclerostin和DKK-1中和抗體的開發研究，有望對于骨代謝疾病治療，獲得新進展。

Sclerostin ELISA Kit (BI-20492)

檢測方法

夾心ELISA，HRP/TMB顯色系統

樣本

血清、血漿

樣本量

20ul/test，12 x8 test

檢測范圍

0-240pmol/L

靈敏度

2.6pmol/L

孵育時間

過夜/1h/30min

DKK-1和Sclerostins是wnt信號通路的有效的抑制劑，且在成骨細胞的分化過程中發揮重要作用。研究表明，骨形成減少、多發性骨髓瘤或由乳腺癌、前列腺癌、肺癌或關節炎引起的骨轉移，都可導致DKK-1水平升高，

Dickkopf-1 ELISA kit (BI-20413)

檢測方法

夾心ELISA，HRP/TMB 顯色系統

樣本

血清、細胞培養上清

樣本量

20ul/test，12 x8 test

檢測范圍

0-160pmol/l

靈敏度

1.7pmol/L

孵育時間

2h/1h/30min

sRankl 是（NF）-KB配體的可溶性受體激活因子，是成熟破骨細胞形成的主要刺激因子，對于破骨細胞的存活具有重要作用。Rankl 激活位于成骨細胞及樹突細胞其特異性受體Rank。

sRankl ELISA kit (BI-20452)

檢測方法

夾心ELISA，檢測系統：AP/ NADPH

樣本

血清、血漿、細胞培養上清

樣本量

100ul/test，12 x8 test

檢測范圍

0-2pmol/L

靈敏度

0.02pmol/L

孵育時間

過夜/1h/30min

OPG是Rankl的可溶性分泌受體，可抑制破骨細胞的發育。

Osteoprotegerin(OPG) ELISA kit (BI-20403)

檢測方法

夾心ELISA，檢測系統：HRP/TMB

樣本

血清、血漿

樣本量

20ul/test，12 x8 test

檢測范圍

0-20pmol/L

靈敏度

0.07 pmol/L

孵育時間

3h/1h/30min

Cathepsin K 是破骨細胞活化、重吸收中大量表達的合成蛋白。Cathepsin K含量的升高，反映了sRankl 激活破骨細胞的能力。

Cathepsin K ELSIA kit (BI-20432)

檢測方法

夾心ELISA，檢測系統：HRP/TMB

樣本

血清、細胞培養上清

樣本量

50ul/test，12 x8 test

檢測范圍

0-300pmol/l

靈敏度

1.1pmol/L

孵育時間

過夜/30min

參考文獻

試驗設計

結論

Association of sclerostin levels with the severity of aortic valve calcification. Koos R et al., JACC ; 2011; 57, 14

心臟主動脈瓣硬化患者

樣本：115例

與正常人群相比心臟主動脈瓣硬化（AVC）患者，sclerostin水平顯著升高。AVC疾病的嚴重程度與sclerostin血清水平相關。

Sclerostin and Dickkopf-1 in Renal Osteodystrophy. Cejka D et al., Clin J Am Soc  Nephrol; 2011; 6: 877-882

慢性shen臟病患者（CKD-5D）

樣本：60例

針對高轉換性骨代謝的CKD-5D病人除了檢測IPTH外，還可檢測Sclerostin作為評價指標。

Sclerostin serum levels correlate positively with bone mineral density and microarchitecture in haemo-dialysis patients. Cejka D et al.,  Nephrol DiaTransplant; 2012; 27: 226-230

血透患者

樣本：76例

對照樣本：45例

血透患者的sclerostin水平，顯著高于對照樣本。骨密度（BMD）與血清sclerostin水平呈正相關。

Circulating Sclerostin Levels and Bone Turnover in Type 1 and Type 2 Diabetes. Gennari L et al., J Clin Endo Metab; 2012; 97: 1737-1744

II型糖尿病患者（DM2）：40例

I型糖尿病患者（DM1）：43例

對照樣本：83人

研究表明，DM2患者sclerostin水平升高。此外，由PTH 抑制轉錄sclerostin可能在DM1和DM2病人減弱。

Circulating sclerostin and Dickkopf-1 (DKK1) in predialysis chronic kidney disease (CKD): relation-ship with bone density and arterial stiffness. Thambiah S et al., Calcif Tissue Int; 2012; 90(6): 473-480

慢性shen臟疾病（CKD）3B期患者32例

慢性shen臟疾病（CKD）4期患者：45例

Sclerostin水平與年齡成正相關。男性Sclerostin水平要高于女性。shen小球濾過率（GFR）與Sclerostin水平呈負相關。骨密度（BMD）與血清sclerostin水平呈正相關。Wnt 信號通路可能在代謝紊亂疾病中發揮重要作用。

2013 ISN 研討會會議論文（骨病與shen病）

試驗設計

結論

Bone density and arterial stiffness are related to circulating sclerostin and Dickkopf-1 (DKK1) in pre-dialysis chronic kidney disease (CKD) patients. Goldsmith D et al.,  Poster # 15

血透前患者：

CKD 3B期和4期患者：77例

該研究為：Wnt 信號通路抑制劑（Sclerostin 及DKK-1）在確定骨骼和血管功能及慢性shen臟病人（CKD）結構中發揮重要的作用，提供有力證據。

Circulating sclerostin levels and vascular calcification in chronic kidney disease: A

complex relationship. Claes KJ et al.,Poster # 91

無機代謝縱向研究：154例

AC患者表達高水平的sclerostin。反之，sclerostin較低。后續的臨床和實驗研究需進一步闡明sclerostin是否在保護血管鈣化中起到重要作用。

Sclerostin and DKK-1 levels in pre-dialysis CKD patients. Behts G et al.;  Poster # 89

觀測性研究：

149病人（慢性shen病患者CKD 1-5期，男性：81例，60±16歲，22位糖尿病患者）

隨著shen病嚴重程度，sclerostin（非DKK-1）水平升高。

Low PTH and high circulating sclerostin levels are independently associated with low bone specific alkaline phosphatase levels in hemodialysis patients. Viaene L et al., Poster # 90

血透病人：100例

Sclerostin水平的升高是糖尿病患者、shen功能不全（RRF）、急性胰腺炎(BSAP)患者的獨立的風險因素。Sclerostin水平的高表達及PTH 的低表達與BSAP相關，反映了低水平的骨質形成。

*作者及參考文獻

疾病

研究群體/試驗設計

主要結論

Sclerostin: another bone-related protein related to all-cause mortality in haem dialysis? Viaene L et al., Nephrol Dial Transplant, 2013; 10.1093/ndt/gft039

 shen病

血透患者（觀察隨后637天個體的生存率），100例

血透患者Sclerostin水平的升高與提高生存率相關。

The Relation between Renal Function and Serum Sclerostin in Adult Patients with CKD. Pelletier S et al., Clin J Am Soc Nephrol, 2013; 8: 819-823

慢性shen病患者（CKD）：90例

在CKD III 期：Sclerostin水平開始升高。

Sclerostin and DKK-1 levels in pre-dialyisis CKD patients. Behets G et al., Nephrol Dial Transplant, 2012; 27: ii36-ii37

慢性shen病患者（橫向觀察性研究）：149例

隨著shen病嚴重程度，sclerostin（非DKK-1）水平升高。

Sclerostin serum levels correlate positively with bone mineral density and microarchitecture in haemodialysis patients. Cejka D et al., Nephrol Dial Trans-plant, 2012; 27: 226-230

血透患者（橫向研究）：76例

血透患者的sclerostin水平，顯著高于對照樣本。

Sclerostin Levels Associated with Inhibition of the Wnt/β-Catenin Signaling and Reduced Bone Turnover in Type 2 Diabetes Mellitus. Gaudio A et al., J Clin Endocrinol Metab, 2012; 97: 3744–3750

糖尿病

絕經婦女II型糖尿病患者（橫向研究）：40例

與之前研究結果一致，II型糖尿病患者sclerostin水平高于對照樣本及骨轉換標記物水平低于對照樣本。

Circulating Sclerostin Levels and Bone Turnover in Type 1 and Type 2 Diabetes.

Gennari L et al., J Clin Endo Metab, 2012; 97: 1737-1744

I型和II型糖尿病患者（橫向研究）

DM1：43例   DM2：40例

研究表明：II型糖尿病患者sclerostin水平升高。

Association of Sclerostin levels with the severity of aortic valve calcification. Koos et al., JACC, 2011; 57, 14

心臟主動脈瓣硬化

主動脈瓣患者（橫向研究）：115例

與正常健康對照樣本群體比較，AVC患者sclerostin水平升高。

Serum Sclerostin levels are associated with aortic valve calcification in prevalent ha-emodialysis patients. Türkvatan A et al., Nephrol Dial Transplant, 2013; 28: i19–i21

血透患者：101例

AVC患者sclerostin血清水平顯著高于未鈣化的AVC患者相比，。

Circulating Sclerostin and Dickkopf-1 (DKK1) in predialysis chronic kidney disease (CKD): relationship with bone density and arterial stiffness. Thambiah S et al., Calcif Tissue Int, 2012; 90(6): 473-480

動脈硬化

慢性shen病患者CKD 3BQ期和4期：77例

shen小球濾過率（GFR）與Sclerostin水平呈負相關。Wnt 信號通路可能在代謝紊亂疾病中發揮重要作用。

檢測特點

BI-20413

BI-20412

孵育時間

2h/1h/30min

孵育過夜

樣品處理

直接測定

需要1:4稀釋

標準品范圍

0-160pmol/L

0-50pmol/L

1

Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin

and Dickkopf-1 Levels of Naive Postmenopausal Women With Low Bone Mass: A

Randomized, Head-to-Head Clinical Trial. Athanasios D. Anastasilakis, et al.

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2

Elevated Serum Dickopff-1 Levels Increase Risk of Hip and Vertebral Fracture in Older Caucasian Women. Aarthi Arasu,et al. Endocr. Rev., Jun 2013; 34: SAT-224.

3

Genetic studies on components of the Wnt signalling pathway and the severity of joint destruction in rheumatoid arthritis. Diederik P C de Rooy,et al. Ann Rheum Dis, May 2013; 72: 769 - 775.

4

High dickkopf-1 levels in sera and leukocytes from children with 21-

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5

Sclerostin and DKK1 in postmenopausal osteoporosis treated with denosumab. D Gatti,et al. J Bone Miner Res, Nov 2012; 27(11): 2259-63. 

6

Sclerostin Levels Associated with Inhibition of the Wnt/β-Catenin Signaling and Reduced Bone Turnover in Type 2 Diabetes Mellitus. Agostino Gaudio,et al. J. Clin. Endocrinol. Metab., Oct 2012; 97: 3744 - 3750.

7

Serum Osteoprotegerin, RANKL, and Dkk-1 Levels in Adults with Langerhans

Cell Histiocytosis. Polyzois Makras,et al. J. Clin. Endocrinol. Metab., Apr 2012; 97: E618 - E621

8

High level of functional dickkopf-1 predicts protection from syndesmophyte

formation in patients with ankylosing spondylitis. Gisela Ruiz Heiland,et al. Ann Rheum Dis, Apr 2012; 71: 572 - 574. 

9

Assessment of circulating Dickkopf-1 with a new two-site immunoassay in

healthy subjects and women with breast cancer and bone metastases. N Voorzanger-Rousselot, et al. Calcif Tissue Int, May 1, 2009; 84(5): 348-354

10

Circulating Dickkopf-1 and Radiological Progression in Patients with Early

Rheumatoid Arthritis Treated with Etanercept. Patrick Garnero,et al. J Rheumatol, Oct 2008.

11

Increased Sclerostin Serum Levels Associated with Bone Formation and Resorption Markers in Patients with Immobilization-Induced Bone Loss. Agostino Gaudio,et al. J. Clin. Endocrinol. Metab., May 2010; 95: 2248 - 2253.

12

High Serum Sclerostin Correlates with Advanced Stage, Increased Bone

Resorption, Reduced Osteoblast Function, and Poor Survival in Newly-Diagnosed Patients with Multiple Myeloma. Evangelos Terpos,et al. Blood (ASH Annual Meeting Abstracts), Nov 2009; 114: 425.

13

The Effect of Zoledronic Acid on Serum Dickkopf-1, Osteoprotegerin, and RANKL

in Patients with Paget's Disease of Bone. S A Polyzos, et al. Horm Metab Res, Aug 2009 

14

Glucocorticoids Attenuate the Stimulatory Effect on Bone Formation by

Bortezomib. Thomas Lund,et al. Blood (ASH Annual Meeting Abstracts), Nov 2008; 112: 5183. 

參考文獻

試驗設計

結論

Elevated plasma levels of endostatin are associated with chronic kidney disease. J Chen, LL Hamm, et al.Am J Nephrol, Jan 2012; 35(4): 335-340

CKD患者：201例

對照群體：201例

血漿Endostain的升高，與CKD患者高度相關。進一步研究及臨床實驗已批準驗證Endostain與CKD發病風險之間的關系及研究針對Endostain的新的干預措施，以減少CKD的發病風險。

Early-onset coronary artery disease after pediatric kidney transplantation: implicatingthe angiogenesi inhibitor, endostatin. CW Iqbal,et al. Am Surg, Jun 2011; 77(6): 731-735

接受shen移植者：12例

接受肝移植者：8例

與肝移植者及健康對照個體相比，shen移植者Endostain水平升高。Endostain在shen移植后引起的動脈硬化疾病中發揮重要作用，且Endostain可能作為動脈硬化疾病檢測的生物標記物。

Immobilized kidney 28-kDa endostatin-related (KES28kDa) fragment

promotes endothelial cell survival.MH Bellini, et al.

Am J Nephrol, Jan 2010; 31(3): 255-261

可溶性和固定化的Endostatin 對細胞活性影響。

研究表明：由急性shen損傷（AKI）引起的局部合成28KD相關的Endostain片段，對于內皮細胞的存活，發揮重要作用。

Endostatin and angiostatin are increased in diabetic patients with coronary artery disease and associated with impaired coronary collateral formation. Neel R. Sodha, et al.Am J Physiol Heart Circ Physiol, Feb 2009; 296: H428-H434

經動脈搭橋術手術病人的心肌組織

（非糖尿病例：11例 ，II型糖尿病：10例）

研究表明：在促血管新生治療中，Endostain是潛在的治療靶點，且糖尿病患者可見血管損傷。

A defective angiogenesis in chronic kidney disease.N Futrakul,et al. Jan 2008; 30(2): 215-217

通過研究血管生成因子、Endostain、VEGF、抗血管生成因子之間的平衡，來反映血管損傷程度。

慢性shen病(CKD)患者Endostain及CEC非正常升高，而VEGF表現為缺乏。

1

Infliximab Treatment Increases Left Ventricular Ejection Fraction in Patients with Rheumatoid Arthritis: Assessment of Heart Function by Echocardiography, Endothelin 1, Interleukin 6, and NT-pro Brain Natriuretic Peptide. PRZEMYSLAW J,et al. J Rheumatol, Apr 2012; 39: 701 - 706.

2

Left Ventricular Function Impairment in Patients With Normal-Weight Obesity:

Contribution of Abdominal Fat Deposition, Profibrotic State, Reduced Insulin

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3

Prognostic value of left atrial expansion index and exercise-induced change in atrial natriuretic peptide as long-term predictors of atrial fibrillation recurrence..Malini Govindan,et al. Europace, Sep 2012; 14: 1302 - 1310.

4

Osteopontin-mediated myocardial fibrosis in heart failure: a role for lysyl

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High-sensitivity troponin assay improves prediction of cardiovascular risk in

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6

Translational phases of evidence in a prognostic biomarker: a systematic review and meta-analysis of natriuretic peptides and the prognosis of stable coronary disease. Shailen Sutaria,et al. Heart, Apr 2012; 98: 615 - 622. 

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8

Troponin T, N-terminal pro natriuretic peptide and a patent ductus arteriosus

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14

Prevalence of Left Ventricular Diastolic Dysfunction in a General Population. Tatiana Kuznetsova,et al. Circ Heart Fail, Mar 2009; 2: 105 - 112.

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2

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3

N-Terminal Pro-B-Type Natriuretic Peptide as an Indicator of Possible Cardiovascular Disease in Severely Obese Individuals: Comparison with Patients in Different Stages of Heart Failure. Hermann-Arnhof K et al., Cl inical Chemistry 2005; 51:138-143

4

Natriuretic Peptides: New Players in Energy Homeostasis.  Moro C and Smith RH, Diabetes 2009; 58: 27-26

5

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6

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7

Neurohormonal risk stratification for sudden death and death owing to progressive heart failure in chronic heart failure. Berger R et al, Eur J Clin Invest 2005, 35, 24-31

8

Natriuretic peptides/cGMP/cGMP-dependent protein kinase cascades promote muscle mitochondrial biogenesis and prevent obesity. Miyashita K et al., Diabetes 2009; 58: 2880-2892

9

Processing of Pro–B-Type Natriuretic Peptide: Furin and Corin as Candidate Convertases. Semenov AG et al., Clin Chem. 2010; 56:1166-1176

1

C4d deposition is associated with inferior kidney allograft outcome independ.of cellular rejection. Regele H. et al., Nephrol Dial Transplant. 2001, 16(10): 2058-2066.

2

Capillary C4d deposition in kidney allografts: a specific marker of alloantibody-dependent graft injury. Böhmig GA et al., J Am Soc Nephrol. 2002, 13(4): 1091-1099.

3

[C4d]FlowPRA screening—a specific assay for selective detection of complement-activating anti-HLA alloantibodies. Wahrmann M et al., Hum Immunol, 2005, 66(5): 526-534

4

Pivotal role of complement-fixing HLA alloantibodies in presensitized kidney allograft recipients. Wahrmann M et al., Am J Transplant, 2006, 6: 1033-1041.

5

In vitro detection of C4d-fixing HLA alloantibodies: associations with capillary C4d deposition in kidney allografts. Bar G et al., Am J Transplant, 2008, 8(1): 41-49

6

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7

Solid phase detection of C4d-fixing HLA antibodies to predict rejection in high immunological risk kidney transplant recipients. Bar G et al., Transpl Int. 2013; 26(2): 121-130.

8

Preformed complement-activating low-level donor-specific antibody predicts early antibody-mediated rejection in renal allografts. Lawrence C et al., Transplantation 2013 Jan 27; 95(2): 341-346.

9

Modified solid-phase alloantibody detection for improved crossmatch prediction. Wahrmann M et al., Hum Immunol. 2013 Jan; 74(1): 32-40.

類別

貨號

名稱

規格

骨代謝系列

BI-20492

Sclerostin (SOST) ELISA 

1 Kit

BI-20413 

DKK-1 ELISA 

1 Kit

BI-20432 

Cathepsin K ELISA Kit

1 Kit

BI-20403

OPG ELISA

1 Kit

BI-20452

sRANKL ELISA

1 Kit

心血管疾病

BI-20742 

Endostatin ELISA

1 Kit

BI-20082H

Big Endothelin-1 ELISA

1 Kit

BI-20052

Endothelin ELISA

1 Kit

BI-20872 

NT-proCNP ELISA

1 Kit

BI-20852W

BNP Fragment ELISA

1 Kit

SK-1204

NT-proBNP ELISA

1 Kit

BI-20892

proANP ELISA

1 Kit

動脈硬化

氧化應激

BI-20032

Anti-Oxidized LDL (oLAB) ELISA

1 Kit

BI-5007

OxyStat Assay (Peroxides)ELISA

1 Kit

BI-20022

MDA-oxLDL ELISA

1 Kit

傳染病

BI-21032 

Borrelia lgG ELISA

1 Kit

BI-21042

Borrelia lgM ELISA

1 Kit

BI-3501 

Rheumatoid Factor Stripper

1 Kit

細胞增殖

BI-5000

EZ4U Cell Proliferation Assay

1 Kit

抗體

BI-RC4D

Polyclonal Anti-human C4d antibody

200ul

BI-RC4D-FITC

Polyclonal Anti-human C4d FITC Antibody

100 µl

BI-RC4D-PE

Polyclonal Anti-human C4d PE Antibody

50 µl