糖化血红蛋白检测仪.pdf

糖尿病与糖化血红蛋白检测糖尿病与糖化血红蛋白检测中兴科仪（北京）贸易有限公司中兴科仪（北京）贸易有限公司中仪康辉010-64179238 64162378糖尿病人的血糖水平糖尿病人的血糖水平中仪康辉糖尿病病因糖尿病病因目前仍不知确认的病因。只知糖尿病为一缓慢渐进性的自身免疫性疾病。自身免疫性疾患病人体內自性的自身免疫性疾病。自身免疫性疾患病人体內自发性的產生具破坏性的抗体，而攻击自己的组织。糖尿病人体內可检测出各种会破坏胰腺中的細胞糖尿病人体內可检测出各种会破坏胰腺中的細胞的抗体和淋巴球。细胞因而逐渐遭到破坏。当80-90%左右的细胞被破坏后临床上便逐渐出现症狀。90%左右的细胞被破坏后临床上便逐渐出现症狀。中仪康辉临床临床症症狀狀临床临床症症狀狀 常見的症狀有多尿、多饮、消瘦、多食、倦怠、夜尿（甚至尿床）、腹痛、呕吐、口腔或阴部夜尿甚尿床腹痛呕腔或阴部细菌感染。严重的会脫水。約有1/3-1/2的病童发生糖尿病严重的会脫水。約有1/3 1/2的病童发生糖尿病酮酸中毒（diabetic ketoacidosis,DKA）他的尿液中会有酮体出現血液会转为酸性 他的尿液中会有酮体出現，血液会转为酸性（血浆HCO3-15 mEq/L），病童會有严重的脫水呼吸急促而且用力称为糖尿病酮酸中中仪康辉脫水，呼吸急促而且用力，称为糖尿病酮酸中毒。正常人的正常人的血血标准标准正常人的正常人的血血标准标准FPG 100 mg/dloror?2-h PG(OGTT)200?PG 200 mg/dlor?FPG 126 mg/dlor?2-h PG(OGTT,75 gm)200 mg/dl中仪康辉G(OG,75g)00g/dPrePre-diabetes diabetes(IFG&IGT)126mg/dl 100mg/dl126 mg/dl(FPG)100 mg/dlor200(2 h PG OGTT)140200 mg/dl 140 mg/dl中仪康辉IFG:Impaired Plasma GlucoseIFG:Impaired Plasma GlucoseIGT:Impaired Glucose Tolerance 糖尿病治疗的总体目标糖尿病治疗的总体目标）消除糖尿病的症狀）避免低血糖和酮酸症的发生）恢复日常的活力）恢复日常的活力）預防血管病变和其他的并发症）确保身体和心理的正常发展）维持健全的家庭和人际关系中仪康辉）维持健全的家庭和人际关系监测监测监测监测）自我血糖监测(self-monitoring of blood glucose,SMBG)理想情形是维持饭前血糖在饭后但应依 病童 的年龄是维持饭前血糖在70-140，饭后140 mg/dl。但应依 病童 的年龄和处理低血糖的能力酌情调整。）糖化血红蛋白(HbA1c)糖化血红蛋白反映病童最近个月來血糖的平均值和糖尿病控制的好坏。最好能维持在 7.0%以下。）尿酮：必须为阴性）尿酮：必须为阴性。）血脂：total Cholesterol,Triglyceride,DHL-Chol和 LDL-Chol要保持 正常。5）尿微量白蛋白(microalbuminuria)：发病5-6年后，必须开始测量，期能早期检肾病变。中仪康辉Monitoring DiabetesMonitoring Diabetes Blood glucose:self testing.gHl bi A1 Hemoglobin A1c(HbA1c)testing:hospital,lab or Dr.office testing.中仪康辉office testing.What is Glycated Hemoglobin?What is Glycated Hemoglobin?化血红蛋白化血红蛋白是是葡萄葡萄和和血色素长期接触血色素长期接触所所形成形成化血红蛋白化血红蛋白是是葡萄葡萄和和血色素长期接触血色素长期接触所所形成形成，HbA1c只是众多化血红蛋白中的一种。只是众多化血红蛋白中的一种。它是血代謝的指标它是病并发症的危险参数它是病并发症的危险参数-chain N端端ValineGlucose它是病管/治疗的指标它是病管/治疗的指标中仪康辉?化作用也会发生在化作用也会发生在鍵的鍵的N端和端和，鍵上的鍵上的lysin上上。2003,美國ADA建议统一定名为A1C.美國ADA建议统一定名为A1C.FORMATION OF GLYCATED HEMOGLOBINHemoglobin+GlucoseHemoglobin+GlucoseFastNon-enzymatic reactionSchiff Base(labile)Schiff Base (labile)HbA1Slow,irreversible中仪康辉HbA1c(stable)化血红蛋白化血红蛋白与与血的血的关系关系化血红蛋白化血红蛋白与与血的血的关系关系 形成形成速速与与血血中中葡萄葡萄浓浓成正比成正比。形成形成速速与与血血中中葡萄葡萄浓浓成正比成正比。好的血标记，可反应过去好的血标记，可反应过去2-3个月血平个月血平均值。均值。較較客观客观、方方、受受饭后饭后血血升高升高的的。較較客观客观、方方、受受饭后饭后血血升高升高的的 RBC第第0-30天的前段生命期反应天的前段生命期反应50%的化血的化血红蛋白红蛋白值值红蛋白红蛋白值值。美国美国DCCT已已建建各种各种解读解读A1C的的临床数据临床数据，中仪康辉可供引用。可供引用。化血红蛋白化血红蛋白(AlC)与平均血值的关系与平均血值的关系中仪康辉Mean Glucose vs.HbA1cMBGMPG*MBGmg/dL%HbA1cMPG*mg/dL609012045665100135Non-Diabetic120150180678135170205Target8021024027089101105240275310Action Required中仪康辉2703001112310345Plasma glucose=blood glucose*1.11(Clin.Chem.44:3,655-659)为么要重视病?糖尿病糖尿病糖尿病糖尿病医疗面向医疗面向糖尿病糖尿病糖尿病糖尿病最常导致视网膜病变及失明最常导致视网膜病变及失明最常导致非外伤性截肢最常导致末期肾脏最常导致非外伤性截肢最常导致末期肾脏病病及洗及洗腎腎心血管致死率是一般人的心血管致死率是一般人的中仪康辉病病及洗及洗腎腎治疗治疗2-4倍倍這這些些并发症并发症可以控制可以控制与预防与预防吗吗這這些些并发症并发症可以控制可以控制与预防与预防吗吗?HbA1c During the DCCTIntensive vs Conventional Treatment11Intensive vs Conventional TreatmentA1C%10%)9 0A1C%89HbA1c(9.078Quarterly 7.06Q中仪康辉1234567895Study Time in YearsDCCT STUDYDCCT STUDYDiabetes Control and Complications Trial 1982 to 1993.1 441 IDDMtitti it d 1,441 IDDM patients participated.Overall cost:$165 million.Final report:ADA 1993 annual meeting.Intensive treatment：A1C：7.0%.Conventional treatment：A1C：9.5%.中仪康辉Conventional treatmentA1C9.5%.DCCT研究结果研究结果Retinopathy 发生率減少发生率減少76%Nephropathy发生率減少发生率減少56%Neuropathy 发发生率生率減少減少60%py 发发生率生率減少減少Ps:Type I and Type II DM 有相同結果有相同結果中仪康辉Ps.:Type I and Type II DM.有相同結果有相同結果。美国美国ADA recommendations for Diabetes carequality(2005)Perform the A1C test at least 2 times per year in t bltitstable patients.Achieve A1C 7.0%as goal of glycemic control.gg yLower A1C is associated with lower risk ofLower A1C is associated with lower risk of cardiovascular diseases.中仪康辉A1C 6.0%can be considered in individual patients.UK(英国)Consensus StatementUK(英国)Consensus StatementGlil i bid bHbA1Glycemic control is best monitored by HbA1cThe assay used should be a DCCT-aligned HbA1c method.hd hld hbli hi(3%)dThe assay used should have acceptable within(3%)and between(9 5%)Poor HbA1c Control*(9 5%)252137106746Good HbA1c Control(7.0%)Good HbA1c Control(9(9.5%)5%)37505867634574Lipid Control(130 mg dl)BP 140/90 mm HgLipid Control(130 mg dl)BP 140/90 mm Hg200320001997601778368545Monitoring for NephropathyLipid Control(100 mg dl)Monitoring for NephropathyLipid Control(300g/mg creatinine中仪康辉 Clinical albuminuria:300 g/mg creatinineFrom ADA(American Diabetes Association)criteriaMicroalbuminuria(微白蛋白微白蛋白)()Methodology:Methodology:Nephrometry(散色比浊法散色比浊法)免疫免疫比比浊浊法法Immuno-turbidimetry(免疫免疫比比浊浊法法)Immuno-chromatography(免疫层析法免疫层析法)Specimen:at least 2 ml.random urine Limitation:Physical exercise,infection,fever,congestive heart failure,marked hyperglycemia,and 中仪康辉ypg ymarked hypertension can result in increased microalbumin levels.Clinical applicationNormal reference rangeNormal reference rangeAge Urine ACR(ug/mg creatinine)MWMen Women50 yr.6.9+/-4.7 8.2+/-4.4 y04 8/3 66 2/4 0中仪康辉50yr.4.8+/-3.6 6.2+/-4.0Annals of Clin.&Lab.Science,2005,35,2,p149Normal reference range in age group中仪康辉Annals of Clin.&Lab.Science,2005,35,2,p149Microalbuminuria related to CVD and Diabetes中仪康辉Annals of Clin.&Lab.Science,2005,352,p149中仪康辉From Diabetes Care,1994,17,8,p891Development of MicroalbuminuriadGlid Bldlunder Glycemic and Blood pressure control中仪康辉From Diabetes Care,2005,28,11p2376Progression and Regression of Microalbuminuriaunder Glycemic and Blood pressure controlunder Glycemic and Blood pressure control中仪康辉From Diabetes Care,2005,28,11,p2376Steno-2 study in type 2 diabetes yyp(with microalbuminuria)Condition:160 high-risk type 2 diabetic patients with microalbuminuria aged 55.1 years(average),who were microalbuminuria aged 55.1 years(average),who were randomly assigned to a conventional or an intensive,multifactorial intervention for a period of 7.8 years.Results:44%of patients in the conventional group Results:44%of patients in the conventional group had a cardiovascular event compared with 24%in the intensive group,ie,a relative risk reduction of b0%about 50%the relative risk of nephropathy,retinopathy,and autonomic neuropathy(secondary end points)was 中仪康辉autonomic neuropathy(secondary end points)was diminished by about 60%in the intensively treated groupMetabolism.2003 Aug;52(8 Suppl 1):19-23.In the intensive grouplifestyle education In the intensive groupGoal-oriented pharmacological treatmenttreatmentReduced-fat diet and exercise Ski ti Smoking cessation Receive angiotensin-converting enzyme(ACE)inhibitor regardless of blood pressure.中仪康辉Vitamin supplementation and aspirinACR distribution,DM patients v.s.Normal control groups300350400150200250個 案 個 案 50100150個個0頻率(彰化)6021912159612316201861110272724599142221()1000中仪康辉頻率(台中)303541931266959402226111514486027211718244535頻率(對照)4196100000000000000000百分比(彰化)7.67%28.01 15.47 7.54%7.80%2.94%2.05%2.56%2.30%0.77%1.41%1.28%3.45%3.45%3.07%0.64%1.15%1.15%1.79%2.81%2.69%百分比(台中)2.39%28.23 15.39 10.05 5.50%4.70%3.19%1.75%2.07%0.88%1.20%1.12%3.83%4.78%2.15%1.67%1.36%1.44%1.91%3.59%2.79%百分比(台中)2.39%28.23 15.39 10.05 5.50%4.70%3.19%1.75%2.07%0.88%1.20%1.12%3.83%4.78%2.15%1.67%1.36%1.44%1.91%3.59%2.79%百分比(對照)13.33 63.33 20.00 3.33%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%0.00%Distribution Of Microalbuminuria(ACR ug/mg creatinine)Distribution Of Microalbuminuria(ACR ug/mg creatinine)in Diabetes patientsin Diabetes patientsin in DiabetesDiabetes patientspatientsACR300ACR3008%8%ACR in30300ACR in303008%8%ACR3066%ACR30030300030中仪康辉ACR and A1C相关性分析图相关性分析图(III)4.002793.00A C2.00L C R 0 001.00O G-1.000.00中仪康辉12345 678A1C range 16.0%26.17.0%37.18.0%48.19.0%59.110.0%610.111.0%711.012.0%812.0%结结伦伦1.34%的受檢者已有蛋白(Proteinuria),其中1.34%的受檢者已有蛋白(Proteinuria),其中结结伦伦26%為microalbuminuria.26%為microalbuminuria.2.Microalbuminuria 與高血壓、HbA1c和病2.Microalbuminuria 與高血壓、HbA1c和病有正比關係。有正比關係。3.用 Blood Creatinine level作為評估早期3.用 Blood Creatinine level作為評估早期中仪康辉腎病變的指標,敏感如microalbumin。腎病變的指標,敏感如microalbumin。NycoCardU-Albumin-for measurement of low albumin concentrations in human urinein human urine中仪康辉NycoCardU-Albumin kit contentsCl tf24licontentsComplete for 24 analysis:?24 tubes of Dilution Liquid?q?24 Test Devices?2.0 mL Conjugate2 0 mL Washing Solution?2.0 mL Washing Solution中仪康辉TD/Test DeviceTD/Test Device Plastic device sealed with Plastic device sealed with aluminium foil Membrane coated with Membrane coated with monoclonal anti-albumin antibodies Liquid absorbing layer underneath the membraneEntrapment of human 中仪康辉albuminNycoCard Reader中仪康辉Stability of kit in useStability of kit in use11.21.4y(K/S)0.40.60.81Colour intensity0 mg/L20 mg/L100 mg/Lpos.contr.00.205101520 25303540455055606570 7580859095Storage time(days)Cpos.contr.An opened test kit was stored refrigerated at 4C.In 中仪康辉pghouse reference material and NycoCardU-Albumin Control were analysed regularly over a 3 months period.ygypNo significant change in any kit component was observed during this period.NycoCard for A1C testNycoCard for A1C test中仪康辉NycoCardNycoCard RAPID Result within 3 MINUTES during patient consultationconsultationFINGER PRICK,WHOLE BLOOD(5L)applicable(make use of blood lancet or EDTA tube)STANDARDIZEDdit thd tifSTANDARDIZED according to the recommendations of the ERL Laboratory(European Reference Laboratory)Measuring Range:3-18%HbA1cggFDA APPROVAL for Diabetes MonitoringSimilar system capable to run CRP,D-Dimer&Microalbumin中仪康辉Microalbumin