非牛顿流体血液黏度质控物的研制

Preparation of Non-Newtonian Fluids Quality Control Material for Blood Viscosity Testing

目的 研制一种非牛顿流体血液黏度质控物,用于实验室血液黏度检测的质量控制.方法 将选定的有机高分子化合物配成溶液,加入稳定剂后制成质控物.检测自制质控物和新鲜血的黏度,作黏度-切变率曲线,观察二种流体黏度曲线的相似性;将配制的2个不同浓度水平质控物,按照ISO Guide35的要求分层抽样,使用单因素方差分析方法对质控物进行均匀性评价;使用线性回归分析方法对质控物进行稳定性评价,评价时间已监测到22 w;将自制质控物和仪器配套质控物分别在LBY-N6COMPACT和SA-6000型血液流变分析仪进行室内质量控制检测,检测10 w,计算结果的变异系数;将自制质控物试应用于全国血液黏度室间质量评价调查,回报结果按照室间质评方案进行分组统计,比较各组自制质控物和相近浓度水平质评物的变异系数.结果 自制质控物与新鲜血的黏度-切变率曲线相似,均具有剪切稀化的特性.两批号质控物检测结果的单因素方差分析均显示质控物是均匀的（P＞0.05）.两批号质控物22 w内检测结果的线性回归分析均显示质控物是稳定的（P＞0.05）.室内质量控制结果显示用SA-6000流变仪分别检测自制质控物和配套质控物,检测结果的变异系数分别为1.40%～4.61%和2.06%～5.64%.用自制质控物在LYB-N6COMPACT流变仪分别检测自制质控物和配套质控物,检测结果的变异系数分别为1.54%～5.79%和1.07%～6.51%.室间质评调查结果分组统计显示旋转式测定1组自制质控物和质评物检测结果变异系数分别为5.83%～29.94%和5.12%～34.80%;旋转式测定2组自制质控物和质评物检测结果变异系数分别为7.44%～11.80%和5.53%～10.14%.结论 自制质控物可模拟血液流体的特性,均匀性和稳定性良好,能够满足血液黏度检测质量控制的需要.

Objective To develop a non-newtonian fluids quality control material for blood viscosity testing quality control in clinical laboratory. Methods Control materials were prepared by dissolving high-molecular organic compound in water and adding a stabilizer. The viscosity of prepared materials under different shear rate were tested and compared with that of fresh blood samples in order to observe the fluid characteristics. Two lots （Lots number： 201016 and 201017） of quality control material at a suitable viscosity level of were prepared. According to ISO Guide 35,samples of each lot were strati- fied selected and tested for homogeneity. The results were evaluated using one-way ANOVA;The stability was observed for 22 weeks and results were analyzed by linear regression;Prepared control material and manufactory control material were tested on hemorheology analyzer LBY-N6COMPACT and SA-6000 for internal quality control for 10 weeks ,and then the coefficient of variation （CV） of each was calculated and compared. Prepared control materials also were evaluated in ex- ternal quality assessment which the results were analyzed according to National External Quality Assessment Scheme ,and the （＇V of prepared control material was compared with that of manufactory control material. Two kinds of control material were in same viscosity levels. Results Both the prepared control material and fresh blood showed the characteristics of shear thinning. The one-way ANOVA results showed good homogeneity （P^0.05） and the linear regression results showed good stability （P〉0.05）. The results of internal quality control showed that the CV for prepared control materials and manufactory control materials tested on SA-6000 were 1.40 % - 4.61% and 2.06 % - 5.64 % respective, while that was 1.54%-5.79% and 1.07%-6.51% when they were tested on LBY-N6COMPACT. The external quality assessment results showedthat the CV of prepared control material in rotational viscometers group 1 and group 2 was 5.83%-29.94% and 7. 44%-11. 80% respective,while the CV of test result of manufactory control materials were 5.12%- 34.80% and 5.53%-10. 14% respective. Conclusion The prepared control material has the characteristics of shear thinning just like fresh blood sample and could be used as quality control material for blood viscosity testing.