胆红素氧化酶法测定血清结合胆红素

介绍使用国产胆红素氧化酶和二牛磺酸胆红素校准物建立血清结合胆红素测定方法。测定缓冲液为０．１ｍｏｌ／Ｌ柠檬酸盐缓冲液（ｐＨ＝５．０），胆红素氧化酶浓度５００Ｕ／Ｌ，反应（终点）时间１５分钟。本法线性范围可达２４０μｍｏｌ／Ｌ，批内不精密度＜１０％，回收率为９８．３％～１０７．１％，与重氮方法比较，回归方程为Ｙ（酶法）＝０．９５６Ｘ（重氮法）－０．５１３。本法测定人血清结合胆红素参考值２．５７±２．５６μｍｏｌ／Ｌ（ｎ＝９５）。     

血清肌酐测定基质效应的研究

目的 评价血清肌酐测定常规方法的校准偏差及肌酐制备物常在常规方法上的基质效应.方法 根据美国临床实验室和标准化协会(CLSI)EP14-A2评价方案,同位素稀释液相色谱串联质谱法(ID-LC/MS/MS)测定血清肌酐的方法为比对方法,15种常规肌酐测定系统(7种酶法,8种苦味酸法)为待评方法,测定40个新鲜冰冻人血清和36种制备物的肌酐浓度,评价制备物的基质效应和测定系统的校准偏差.结果 大部分商品制备物(29/30)在苦味酸法系统上表现出基质效应,少部分商品制备物(13/30)在部分酶法系统上表现出基质效应.我中心6个制备物在所有15个系统上均未观察到基质效应.所有常规系统新鲜冰冻血清测定值与比对方法测定值间均呈较好的直线相关,所有苦味酸法和部分酶法测定肌酐方法存在校准偏差.结论 基质效应和校准偏差存在于常规肌酐测定方法,必须重视这些因素,提高肌酐测定结果的正确度和可比性.     

溴甲酚绿浓度对血清白蛋白测定的影响

溴甲酚绿浓度对血清白蛋白测定的影响白峰，赵海舰，徐建平用溴甲酚绿（ＢＣＧ）方法测定血清白蛋白已被普遍采用，我们调查了国产市售２０个生产厂家的ＢＣＧ法测定血清白蛋白试剂盒，发现这些试剂中ＢＣＧ含量差异较大，影响测定血清白蛋白的结果，为此，我们研究了不同...     

同位素稀释液相色谱串联质谱法测定血清睾酮

目的建立一种用同位素稀释液相色谱串联质谱法(ID-LC/MS/MS)测定血清睾酮的候选参考方法。方法以[16,17,17-d3]睾酮为内标,用重量法准确地与血清混合,用乙酸乙酯-正己烷混合溶剂提取,以羟丙基-β-环糊精水溶液对提取液作净化处理,用液相色谱串联质谱分析,质谱选择离子监测模式检测睾酮与内标的特定碎片离子,用包括法定量。结果血清睾酮测定的批内、批间和总变异系数(CV)的均值(范围)为0.84%(0.22%~2.00%)、1.01%(0.48%~2.37%)和1.37%(0.53%~3.09%)。参考物质ERM DA-345a和NIST SRM 971测定结果与认定值的平均偏差范围为-2.0%~+1.8%。结论用ID-LC/MS/MS建立了血清睾酮的测定方法,方法准确、精密、简便,有望作为血清睾酮测定的参考方法。     

用全血干化学和免疫浓缩技术测定骨碱性磷酸酶

骨碱性磷酸酶（ＢＡＬＰ）是由成骨细胞合成的，当小儿体内维生素缺乏时，骨钙化不足，成骨细胞活跃，ＢＡＬＰ上升，其改变先于影像学变化，被认为是诊断小儿佝偻病最特异、最敏感的指标。采用干化学和免疫浓缩技术的原理设计的骨碱性磷酸酶试剂盒，只需３０μｌ全血即可半定量读出骨碱性磷酸酶浓度。测定范围为１７０￣４２０Ｕ／Ｌ，其目测结果与ＷＧＡ亲和沉淀法的符合率为９２．２％。肝、胆和肠碱性磷酸酶对目测小儿血浆骨碱性     

我国心肌损伤标志物不同检测系统质量水平调查

目的分析我国心肌损伤标志物不同检测系统的质量水平。方法将卫生部临床检验中心近4年的室间质评数据及2011年4月各临床实验室上报的室内质控数据按照仪器、试剂和校准品制造商进行分组,室间质评结果进行变异情况分析,室内质控结果按生物学变异导出的质量规范进行分析。结果不同实验室分析变异波动最大的检测指标为cTnI和cTnT,cTnI的稳健CV可达120%,cTnT的稳健CV可超过70%,CK-MB和Mb的变异情况相对较小,稳健CV通常可处于20%以内。各检测系统的室内质控数据分析得出,从1/3TEa的标准来判断,大多数的系统80%以上的实验室满足此要求,从分类等级更高的生物学变异标准来判断,大多数检测系统70%以上的实验室能满足适当的规范要求。结论临床实验室应该重视各检测系统的一致性,提高实验室间结果的可比性,以更好地为临床提供可靠的结果,更好地服务患者。     

胆固醇、HDL-C和甘油三酯试剂盒质量检定标准、检定方法

根据《药品管理法》的有关规定 ,卫生部对体外用诊断药品实行了全面的审批管理制度。卫生部临床检验中心受卫生部的委托 ,自 1 992开始对批准生产、销售的诊断试剂分批实行了质量检定 ,以期能更有效地对诊断试剂的质量进行监督、管理 ,并促进其不断完善提高。但是 ,由于诊断试剂的研制者对检定标准 ,尤其是对检定方法不够了解 ,对提高试剂盒的质量增加了困难。本文具体介绍卫生部临床检验中心对总胆固醇 ( TC)、高密度脂蛋白胆固醇 ( HDL - C)和甘油三酯 ( TG)诊断试剂盒的检定标准和检定方法 ,供试剂研制者参考 ,也可作为使用者对试剂…     

酶校准品在血清酶测定结果标准化中的应用

目的研究酶校准品用于校准不同的“仪器 /试剂”测定系统时 ,能否增加各系统间血清酶测定结果的可比性。方法在日立 7170 A和 CX9全自动生化分析仪上用 4种不同的试剂分别测定 15 0份不同浓度分布的新鲜血清中的丙氨酸转氨酶 (AL T) ,天门冬氨酸转氨酶 (AST) ,碱性磷酸酶〔(AL P) ,10 0份〕,肌酸激酶 (CK) ,γ-谷氨酰转肽酶 (GGT) ,乳酸脱氢酶 (L D)等 6种酶的活性。同 1份标本用 4种不同的“仪器 /试剂”测定系统进行校准前和校准后测定 ,比较各测定系统测定前后的均值。结果发现不同的“仪器 /试剂”系统间的测定结果存在一定差异 (各系统间均值的 CV值≥ 7.0 % ,其中 AL P为 2 7.0 % ,GGT为 17.4% ) ,用统一的酶校准品校准后 ,各系统间测定结果的差异明显减小 (除 AL P和 GGT的 CV值分别为 6 .6 %和 5 .1%外 ,其余各项目的 CV值均 <5 % )。结论统一的某些酶校准品能增加不同的测定系统间结果的可比性。     

全血黏度测定质控品的适用性研究

Objective To exlore the influence of internal quality control and external quality control assessment(EQA) resulting from applicability of control samples in measurement of whole blood viscosity (WBV) through the analysis and comparison of applicability of 1 non-Newtonian fluid internal quality control sample in 3 viscometers. Methods Viscometer B, C and D were used to measure WBV of 30 blood samples in parallel under the shear rate(SR) of 1 s-1,30 s-1 and 200 s-1, then the blood SR-WBV curves of 3 viscometers were drawn according to the results. At the same time, viscometers B, C and D were used respectively to determine the WBV of control A 10 times in one day, then the control A SR-WBV curves were mapped. Three viscometers were used to measure the manufactory control samples and control A 5 times in one day for 4 days. Four groups of daily values of manufactory control samples and control A of each instrument were used to carry out F test to calculate whether 4 daily values are difference. Finally, the control A was dispensed in 49 laboratories nationwide chosen for measurement. On the basis of viscometer used, 20 laboratories were classified as group B, 20 laboratories were classified as group C and 9 laboratories were classified as group D. Then the data under SR of 1 s-1 were analyzed to calculate the coefficient of variation (CV) in the group. Results There was significant difference among the WBV of blood samples measured by the viscometers B, C and D. The results under SR of 1 s-1 declined in turn, and they were highest under SR of 30 s-1 followed by the values of viscometer D and B and they were (8.14±0.75), highest under SR of 30 s-1 followed by the values of viscometer B and D, and they were (7.35±0.07), daily values of manufactory control and control A of each instruments in four groups were compared. Under SR of 1 s-1, there was no difference between daily values of manufactory control and control A in viscometer B (F = 2.63, 1.37, P > 0.05), and there was no difference of daily values of manufactory control among viscometer C and D (F = 0.33,3. 14, P > 0.05), but significant daily difference existed when control A was tested by viscometer C and D (F = 5.76, 8.00, P < 0.05). Under SR of 30 s-1, there was no difference of daily values of manufactory control among 3 viscometers(F =0.31, 0.18, 2.26, P >0.05), and there was no difference of daily values of control A among 3 viscometers' (F = 1.03, 1.83, 2.40, P > 0.05); Under SR of 200 s-1, there was no difference of daily values of manufactory control among 3 viscometers (F =2.59, 0.68, 2.96, P > 0.05), and there was no difference of daily values of control A among 3 viscometers (F=2.31, 3.01, 2.28, P>0.05). When control A was tested under SR of 1 s-1 in 49 laboratories nationwide, the WBV values in groups of viscometer B, C and D were (18.47±1.30), (11.17±2.38), viscometer D and C were 63.75% and 21.3%. Conclusions Control A could fully mimic the properties of whole blood steadily on viscometer B, but partially mimic viscometer C and D, so the control A is most appropriate for viscometer B. Because current non-Newtonian fluid internal quality control could mimic rheological properties of whole blood under specifically conditions, laboratories should evaluate the consistent degree between control and whole blood, only the candidates which can mimic the properties of whole blood approximately could be chosen as quality control of WBV. When third-party control is chosen to be samples of EQA, its applicability should be in consideration. Pretest should be performed adequately to define applicability of third-party control, so as to reduce the difference among laboratories due to applicability of control and reflect detection quality of laboratories exactly.