本文關(guān)鍵詞： 紅細胞保存液 輸血相容性試驗質(zhì)控品 性能評價 質(zhì)控規(guī)則　出處：《廣州中醫(yī)藥大學(xué)》2015年碩士論文　論文類型：學(xué)位論文

【摘要】：目的：室內(nèi)質(zhì)量控制(Internal quality control, IQC)可及時發(fā)現(xiàn)試驗各環(huán)節(jié)存在的誤差,是確保檢測結(jié)果準(zhǔn)確性的重要措施。輸血相容性試驗檢測項目主要包括ABO及Rh血型鑒定試驗、不規(guī)則抗體篩查試驗和交叉配血試驗。通過本研究制備出簡易可行,可在一般實驗室使用的質(zhì)控品。方法：在結(jié)合已有的紅細胞保存液配方的基礎(chǔ)上,添加肌酐、海藻糖、維生素E等試劑,延長紅細胞在保存液中的保存時間,使紅細胞在保存過程中保持抗原的穩(wěn)定性,提高反應(yīng)的靈敏度。制備血漿、紅細胞質(zhì)控品后進行外觀觀察和細菌培養(yǎng),并分析各種室內(nèi)質(zhì)控品檢測結(jié)果的重復(fù)性和穩(wěn)定性；進行室內(nèi)質(zhì)控模式設(shè)計,建立質(zhì)控規(guī)則和結(jié)果判定標(biāo)準(zhǔn),對制備的血漿和紅細胞質(zhì)控品進行性能和效果評價；根據(jù)本實驗室的試驗方法、試劑、耗材及試驗結(jié)果,摸索室內(nèi)質(zhì)控品在各種檢測情況下的最佳應(yīng)用條件和效果。結(jié)果：1、研制出保存時間長達49天的紅細胞保存液(SZY)。其各項性能指標(biāo)穩(wěn)定,A、B抗原在保存過程中反應(yīng)積分均穩(wěn)定在12分；游離血紅蛋白在保存到49天時處于0級水平：FHb500mg/L,無溶血；紅細胞在保存到49天時只有50%發(fā)生形態(tài)改變,優(yōu)于CPDA, MAP組的80%。2、質(zhì)控品的批內(nèi)重復(fù)性評價分析顯示CV均10%,說明研制的質(zhì)控品具有良好的重復(fù)性；批間重復(fù)性評價分析顯示兩批次間差異無統(tǒng)計學(xué)意義(P0.05),說明管間差異小,質(zhì)控品性能穩(wěn)定；質(zhì)控品在不同保存時間的檢測結(jié)果無明顯變化(P0.05),說明質(zhì)控品穩(wěn)定性良好；不同條件下質(zhì)控品測定結(jié)果接近,二者差異無統(tǒng)計學(xué)意義(P0.05),說明自制質(zhì)控品的穩(wěn)定性和精密度較好。質(zhì)控品在兩種不同的檢測方法下,測定結(jié)果無明顯差異(P0.05),說明自制質(zhì)控品性能穩(wěn)定,能運用于不同檢測條件的實驗室,易于推廣。結(jié)論：成功研制出的輸血相容性試驗室內(nèi)質(zhì)控品,批內(nèi)重復(fù)性好,批間差異小,穩(wěn)定性強,能對試劑、溫度和加樣等因素進行有效監(jiān)控,具有很強的實用性。同時制備原料簡單易得,方法簡單易行,適合大部分輸血相容性檢測實驗室使用。利用自制質(zhì)控品開展了室內(nèi)質(zhì)控檢測,初步建立起實驗室的室內(nèi)質(zhì)控體系,提高了試驗室的質(zhì)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.
【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R457.1

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