本文關(guān)鍵詞： 紅細(xì)胞保存液 輸血相容性試驗(yàn)質(zhì)控品 性能評(píng)價(jià) 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(shí)發(fā)現(xiàn)試驗(yàn)各環(huán)節(jié)存在的誤差,是確保檢測(cè)結(jié)果準(zhǔn)確性的重要措施。輸血相容性試驗(yàn)檢測(cè)項(xiàng)目主要包括ABO及Rh血型鑒定試驗(yàn)、不規(guī)則抗體篩查試驗(yàn)和交叉配血試驗(yàn)。通過(guò)本研究制備出簡(jiǎn)易可行,可在一般實(shí)驗(yàn)室使用的質(zhì)控品。方法：在結(jié)合已有的紅細(xì)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(zhǎng)紅細(xì)胞在保存液中的保存時(shí)間,使紅細(xì)胞在保存過(guò)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(xì)胞質(zhì)控品后進(jìn)行外觀觀察和細(xì)菌培養(yǎng),并分析各種室內(nèi)質(zhì)控品檢測(cè)結(jié)果的重復(fù)性和穩(wěn)定性；進(jìn)行室內(nèi)質(zhì)控模式設(shè)計(jì),建立質(zhì)控規(guī)則和結(jié)果判定標(biāo)準(zhǔn),對(duì)制備的血漿和紅細(xì)胞質(zhì)控品進(jìn)行性能和效果評(píng)價(jià)；根據(jù)本實(shí)驗(yàn)室的試驗(yàn)方法、試劑、耗材及試驗(yàn)結(jié)果,摸索室內(nèi)質(zhì)控品在各種檢測(cè)情況下的最佳應(yīng)用條件和效果。結(jié)果：1、研制出保存時(shí)間長(zhǎng)達(dá)49天的紅細(xì)胞保存液(SZY)。其各項(xiàng)性能指標(biāo)穩(wěn)定,A、B抗原在保存過(guò)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(shí)處于0級(jí)水平：FHb500mg/L,無(wú)溶血；紅細(xì)胞在保存到49天時(shí)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(píng)價(jià)分析顯示CV均10%,說(shuō)明研制的質(zhì)控品具有良好的重復(fù)性；批間重復(fù)性評(píng)價(jià)分析顯示兩批次間差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),說(shuō)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(shí)間的檢測(cè)結(jié)果無(wú)明顯變化(P0.05),說(shuō)明質(zhì)控品穩(wěn)定性良好；不同條件下質(zhì)控品測(cè)定結(jié)果接近,二者差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),說(shuō)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(cè)方法下,測(cè)定結(jié)果無(wú)明顯差異(P0.05),說(shuō)明自制質(zhì)控品性能穩(wěn)定,能運(yùn)用于不同檢測(cè)條件的實(shí)驗(yàn)室,易于推廣。結(jié)論：成功研制出的輸血相容性試驗(yàn)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(qiáng),能對(duì)試劑、溫度和加樣等因素進(jìn)行有效監(jiān)控,具有很強(qiáng)的實(shí)用性。同時(shí)制備原料簡(jiǎn)單易得,方法簡(jiǎn)單易行,適合大部分輸血相容性檢測(cè)實(shí)驗(yàn)室使用。利用自制質(zhì)控品開(kāi)展了室內(nèi)質(zhì)控檢測(cè),初步建立起實(shí)驗(yàn)室的室內(nèi)質(zhì)控體系,提高了試驗(yàn)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(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：R457.1

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