C-反应蛋白及临床应用1.ppt

CRP的临床应用 hsCRP的临床应用 * This shows linearity at lower ranges. ? 28 * This is linearity at higher ranges. ? * This shows the comparison of the prozone with our previous reagent and reagents from other companies. Some reagents show slacking down in the range over 50 mg/dL, while Nanopia maintains increase over 50 mg/dL. There is no hook phenomenon even at 100 mg/dL. Nanopia had the best extension in higher range among the all products. ? * What is the definition of high sensitivity in CRP assays? It is a frequently asked question, and currently there are two sets of figures. One is the coefficient of variation for within-run precision of 3% or less at 0.1 mg/dL. The other is a detection limit of 0.02 mg/dL. These were the assay precision that were cleared by FDA of the United States, when Dade Behring received official approval to use their BN2 as a risk marker for ischemic heart diseases. 良く高感度CRPの定義についてご質問を受けますが、現在使われているのはこの数値です。 ひとつは0.1mg/dLでの同時再現性の変動係数が３％以下、 もうひとつは検出限界が0.02mg/dL　という数値です。 これはいずれもデイドベーリング社BN2がアメリカのFDAで虚血性心疾患のリスクマーカー として使用できるだろうとお墨付きを頂いた際にクリアした測定精度です。 * * This shows the stability of precision. Nanopia yielded stable results even after 5 weeks since calibration 此幻灯片试剂盒校准的稳定性，在分析开始时校准，其稳定性可以保持5周。 * Summarizing the characteristics of Nanopia. High sensitivity as performance assay reagent, with detection limit of 0.01 mg/dL Excellent precision Linearity secured over a wide range of 0.01-42 mg/dL No hook phenomenon at 140 mg/dL or over No interference from other serum components Can be utilized for various biochemical automated analyzers ? * This picture is clean automated manufacturing line in our factory Many kinds of products are manufactured everyday * 正常健康人的CRP值非常低，一般＜0.85g／L，90％的正常人＜0.3g/L，99％的正常人CRP＜1.0g／L。而在炎症或急性组织损伤后，CRP的合成则在4-6小时内迅速增加，36-50小时达高峰，峰值可为正常值的100-1000倍，其半衰期较短(4-6小时)。经积极合理治疗后，3-7天迅速降至正常。CRP的水平与组织损伤后修复的程度有密切关系。因此CRP可作为疾病急性期的一个衡量指标，并且CRP不受性别、年龄、贫血、高球蛋白血症、妊娠等因素的影响，因而它优于其它急性期的反应物质。 在美国心脏协会和美国疾病预防控制中心推荐的标准（单位均为毫克/升）