尿液10项肾损伤标志物检测试剂的性能评价

摘要:目的对尿液 10项肾损伤标志物检测试剂进行性能评价,并评估其临床适用性。方法对北京利德曼公司尿液a1 微球蛋白(u-a|MG)、总蛋白(u-TP)、免疫球蛋白G(u-IgG) 、微量清蛋白(u-Alb)、中性粒细胞明胶酶相关脂质运载蛋白(u-NGAL)、半胱氨酸蛋白酶抑制剂C(u-CysC).视黄醇结合蛋白(u-RBP)、β2微球蛋白(u-β2MG)、N-乙酰-β-D-氨基葡萄糖苷酶(u-NAG).、转铁蛋白(u-Trf)检测试剂盒进行性能评价。正确度和精密度验证参考美国临床和实验室标准协会(CLSI)EP15-A3,验证物质采用ERM-DA470k、ERM-DA471、B2M-NIBSC等参考物质及纯度物质;线性验证参考CLSI EP06;抗干扰能力参考CISI EP07;不同检测系统间比对参考CISI EP09。结果正确度方面,10 项标志物检测试剂测定标准物质在低值、中值、高值的偏倚分别为-2.69% ~4.67%、-3.60% ~3.33% .-2.38% ~3.02%;不精密度方面,重复性以不精密度表示,在低值和高值处分别为1.90%~5.43%、0.63% ~2.42%,室内不精密度为2.27%~5.63%、1.09%~3.41%,均满足临床要求;10项尿液标志物线性范围在0.06~4.40 mg/L至21.83~2 146.77 mg/L之间。抗干扰方面,u-1 MG、u-Alb、u-β2MG、u-Trf 、u-CysC、u-NAG分别在血红蛋白终浓度≤8 g/L、≤8 g/L、≤4 g/L、≤4 g/L、≤2g/L、≤1 g/L时,未受到明显干扰(百分偏差≤+ 10%) ,而u-TP、u-IgG、 u-RBP、u-NGAL在血红蛋白终浓度≥0.125 g/L时即受干扰。不同检测系统间偏差超出临床允许范围。结论尿液 10项肾损伤标志物的正确度、精密度、线性范围和抗血红蛋白干扰能力满足临床需要,不同检测系统间标志物测量结果可比性欠佳。     

Adsorptive removal of lead from aqueous solutions by amine–functionalized magMCM-41 as a low–cost nanocomposite prepared from rice husk: Modeling and optimization by response surface methodology

Amorphous silica that was extracted from rice husk was used to synthesize the magMCM-41 mesoporous silica. This was then functionalized by the APTMS group in order to produce NH₂-magMCM-41 as a novel and low–cost adsorbent. The XRD, VSM, N₂ adsorption–desorption, FT–IR, TGA, SEM and TEM analyses were utilized to characterize the produced materials. In order to optimize the adsorption of the Pb(II) ions, the RSM (response surface methodology) was applied by using the synthesized adsorbent in aqueous solutions. A rotatable CCD (central composite design) was adopted to carry out the experiments and RSM was used to analyze them. Three independent factors namely, initial solution pH (3–7), adsorbent dosage (0.1–2 g L^?1), and initial Pb(II) concentration (15–150 mg L^?1) were used to investigate the removal procedure. According to the obtained results, the initial solution pH of 5.22, adsorbent dosage of 0.1 g L^?1, and initial Pb(II) concentration of 150 mg L^?1 were considered as the optimum conditions with 64.32% removal of Pb(II) and an adsorption capacity of 540.64 mg g^?1. The maximum removal efficiency of Pb(II) ions was found to be 96.76%. The Sips isotherm model represents a better correlation with equilibrium data. It was reported by the kinetic study that data taken from the experiments fitted better to the pseudo–second–order model compared to the pseudo–first–order and intraparticle diffusion models. Finally, according to the thermodynamic study, the removal process strongly depends on temperature, which indicates an exothermic behavior and spontaneous nature of the adsorption.     

Challenges with Forecasting Budget Impact: A Case Study of Six ICER Reports

Background

Payers frequently rely on budget impact model (BIM) results to help determine drug coverage policy and its effect on their bottom line. It is unclear whether BIMs typically overestimate or underestimate real-world budget impact.

The Statistical point of view of Quality: the Lean Six Sigma methodology

Six Sigma and Lean are two quality improvement methodologies. The Lean Six Sigma methodology is applicable to repetitive procedures. Therefore, the use of this methodology in the health-care arena has focused mainly on areas of business operations, throughput, and case management and has focused on efficiency outcomes. After the revision of methodology, the paper presents a brief clinical example of the use of Lean Six Sigma as a quality improvement method in the reduction of the complications during and after lobectomies. Using Lean Six Sigma methodology, the multidisciplinary teams could identify multiple modifiable points across the surgical process. These process improvements could be applied to different surgical specialties and could result in a measurement, from statistical point of view, of the surgical quality.