输血相容性试验室内质控品的研制

发布时间：2018-02-22 14:05

本文关键词： 红细胞保存液输血相容性试验质控品性能评价质控规则　出处：《广州中医药大学》2015年硕士论文　论文类型：学位论文

【摘要】：目的：室内质量控制(Internal quality control, IQC)可及时发现试验各环节存在的误差,是确保检测结果准确性的重要措施。输血相容性试验检测项目主要包括ABO及Rh血型鉴定试验、不规则抗体筛查试验和交叉配血试验。通过本研究制备出简易可行,可在一般实验室使用的质控品。方法：在结合已有的红细胞保存液配方的基础上,添加肌酐、海藻糖、维生素E等试剂,延长红细胞在保存液中的保存时间,使红细胞在保存过程中保持抗原的稳定性,提高反应的灵敏度。制备血浆、红细胞质控品后进行外观观察和细菌培养,并分析各种室内质控品检测结果的重复性和稳定性；进行室内质控模式设计,建立质控规则和结果判定标准,对制备的血浆和红细胞质控品进行性能和效果评价；根据本实验室的试验方法、试剂、耗材及试验结果,摸索室内质控品在各种检测情况下的最佳应用条件和效果。结果：1、研制出保存时间长达49天的红细胞保存液(SZY)。其各项性能指标稳定,A、B抗原在保存过程中反应积分均稳定在12分；游离血红蛋白在保存到49天时处于0级水平：FHb500mg/L,无溶血；红细胞在保存到49天时只有50%发生形态改变,优于CPDA, MAP组的80%。2、质控品的批内重复性评价分析显示CV均10%,说明研制的质控品具有良好的重复性；批间重复性评价分析显示两批次间差异无统计学意义(P0.05),说明管间差异小,质控品性能稳定；质控品在不同保存时间的检测结果无明显变化(P0.05),说明质控品稳定性良好；不同条件下质控品测定结果接近,二者差异无统计学意义(P0.05),说明自制质控品的稳定性和精密度较好。质控品在两种不同的检测方法下,测定结果无明显差异(P0.05),说明自制质控品性能稳定,能运用于不同检测条件的实验室,易于推广。结论：成功研制出的输血相容性试验室内质控品,批内重复性好,批间差异小,稳定性强,能对试剂、温度和加样等因素进行有效监控,具有很强的实用性。同时制备原料简单易得,方法简单易行,适合大部分输血相容性检测实验室使用。利用自制质控品开展了室内质控检测,初步建立起实验室的室内质控体系,提高了试验室的质量控制水平。
[Abstract]:Objective: internal quality control (IQC) is an important measure to ensure the accuracy of blood transfusion compatibility test, which includes ABO and Rh blood type identification test. Irregular antibody screening test and cross blood matching test. Through this study, a simple and feasible quality control product which can be used in general laboratory was prepared. Methods: on the basis of the existing formula of erythrocyte preservation solution, creatinine and trehalose were added. Vitamin E and other reagents can prolong the preservation time of red blood cells in preservation solution, keep the stability of antigens and increase the sensitivity of reaction of red blood cells in the process of preservation, prepare plasma, observe the appearance of red blood cells and culture bacteria after the preparation of plasma and quality control products of red blood cells. It also analyzes the repeatability and stability of the test results of various indoor quality control products, designs the indoor quality control mode, establishes the quality control rules and result judging standards, and evaluates the performance and effect of the prepared plasma and red blood cell quality control products. According to our laboratory test methods, reagents, consumables and test results, The optimum application conditions and effects of indoor quality control products under various detection conditions were explored. Results: 1. A erythrocyte preservation solution, SZYA, was developed for 49 days. The reaction integral of AZB antigen was stable at 12 points during the preservation process. The free hemoglobin was at 0 level at 0 grade: FHB 500mg / L, no hemolysis, and the erythrocyte had only 50% morphological changes after 49 days of preservation. The results showed that the CV of the quality control products was 10, which indicated that the quality control products developed had good repeatability, and the repeatability evaluation analysis between the two batches showed no significant difference between the two batches (P 0.05), which indicated that the difference between the two batches was small. The quality control product is stable in performance, the quality control product has no obvious change in the test results of different storage time, which indicates that the quality control product is stable, and the quality control product is similar in different conditions. There was no significant difference between the two methods, which indicated that the stability and precision of the self-made quality control products were good. There was no significant difference in the determination results of the quality control products under two different detection methods, which indicated that the self-made quality control products were stable in performance. Conclusion: the laboratory quality control product developed successfully for blood transfusion compatibility test has good reproducibility, little difference between batches, strong stability, and can be used for reagents. The factors such as temperature and sample are effectively monitored, which has strong practicability. At the same time, the preparation of raw materials is simple and easy to obtain, the method is simple and feasible, and it is suitable for most blood transfusion compatibility testing laboratories. The indoor quality control test is carried out by using self-made quality control products. The laboratory quality control system has been established preliminarily and the quality control level of laboratory has been improved.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R457.1

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