白蛋白是一种蛋白质，在肝脏中合成，在血浆中含量最多。它占人体蛋白质总含量的50%。它在水中具有极强的溶解性，这是由于它具有一个生理ph值的负电荷。它在维持肿瘤压力中起着关键的作用。白蛋白参与类固醇、钙离子、配体和胆红素的运输。临床上，高水平的这种蛋白质很少遇到，并在脱水的情况下可见。低水平具有更大的诊断价值，可见于肝病、胃肠损失、炎症和腹水。在白蛋白测定试剂盒中，白蛋白与溴甲酚绿(BCG)指示剂结合。一种蛋白-卡介苗络合物形成，其吸光度在578nm处测量。样品中白蛋白的浓度与复合物形成的颜色的强度成正比。线性一词是指两个变量之间存在线性关系。这些变量都是递增的，是成正比的，因此数据将以直线表示(Schneider et al.， 2010)。在这种实际情况下，白蛋白测定试剂盒的线性度进行了评估，制造商声称该测定方法的线性度可达62.2g/l，这将得到验证。给出了80g/l白蛋白浓度标准液，并对该标准液进行稀释，验证了该方法的线性度。每一标准品的吸光度随其浓度被标出来。然后评估这两个变量之间的关系，以检验制造商的说法。CLSI文件EP15-A2的目的是验证实验室的性能是否与制造商声称的一致。验证制造商索赔的准确性。
Albumin is a protein, synthesised in the liver and most abundantly found in plasma. It represents 50% of the body’s total content of protein. It is extremely soluble in water, as a result of it having a negative charge at a physiological pH. It plays a pivotal role in maintaining oncotic pressure. Albumin is involved in the transportation of steroids, calcium ions, ligands and bilirubin. Clinically, high levels of this protein are rarely encountered and are seen in cases of dehydration. Low levels possess greater diagnostic value and can be seen in hepatic disease, gastrointestinal loss, inflammation and ascites. In the Albumin Assay Kit that is utilised in this practical, the albumin binds to the bromocresol green (BCG) indicator. An albumin-BCG complex forms and the absorbance of this is measured spectrophotometrically at 578nm. The concentration of albumin in the sample is directly proportional to the intensity of the colour that is formed by the complex .The term linearity refers to there being a linear relationship between two variables. These variables that are both increasing, are directly proportional and so, the data will be represented in a straight line (Schneider et al., 2010). In the case of this practical, the linearity of the Albumin Assay Kit was evaluated and the manufacturer’s claim of this assay being linear up to 62.2g/l is to be verified. An 80g/l albumin concentration standard was given and dilutions of this standard were made to verify the assay’s linearity. The absorbance of each of the standards were plotted versus the concentration of each standard. The relationship between both variables was then evaluated to test the manufacturer’s claim. The CLSI’s document, EP15-A2 is intended to verify if the performance of a laboratory is consistent to that claimed by the manufacturer, i.e verification of the precision of the manufacturer’s claim.
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