【摘要】：目的對廣州地區(qū)基層醫(yī)院正在使用的邁瑞B(yǎng)S-820全自動(dòng)生化儀進(jìn)行性能評價(jià),驗(yàn)證其性能是否滿足臨床需要。方法根據(jù)美國臨床和實(shí)驗(yàn)室標(biāo)準(zhǔn)化協(xié)會(CLSI)推薦的EP5-A2、EP6-A、EP7-A2、EP-17A文件和《中華人民共和國醫(yī)藥執(zhí)業(yè)標(biāo)準(zhǔn)》YY/T0654-2008文件,采用16個(gè)常規(guī)生化項(xiàng)目對邁瑞公司BS-820全自動(dòng)生化儀檢測系統(tǒng)的精密度、線性范圍、抗干擾能力、靈敏度及攜帶污染率進(jìn)行性能評價(jià)。結(jié)果 BS-820系統(tǒng)所進(jìn)行的評價(jià)分析結(jié)果顯示,所有項(xiàng)目的精密度實(shí)驗(yàn)結(jié)果均為合格。15個(gè)生化項(xiàng)目在測試范圍內(nèi)都表現(xiàn)出良好的線性關(guān)系,相關(guān)系數(shù)r≥0.997 9。16個(gè)生化項(xiàng)目中,總膽紅素(TBIL)、總蛋白(TP)、總膽固醇(TC)、三酰甘油(TG)、低密度脂蛋白(LDL)、高密度脂蛋白(HDL)、尿素(UREA)、鈣(Ca)8個(gè)項(xiàng)目的抗膽紅素、TG和血紅蛋白干擾能力符合或高于廠家宣稱的抗干擾能力,其余的8個(gè)項(xiàng)目有1~3種抗干擾能力低于廠家宣稱。16個(gè)生化項(xiàng)目的空白限(LOB)均小于廠家宣稱的LOB。谷氨酸(Glu)的攜帶污染率為0.02%,低于0.50%。結(jié)論該儀器有良好的精密度、靈敏度,攜帶污染率低,線性范圍理想,抗干擾能力基本能滿足臨床需求。適合中小規(guī)模檢驗(yàn)科使用。
[Abstract]:Objective to evaluate the performance of BS-820 automatic biochemical instrument which is being used in primary hospitals in Guangzhou to verify whether its performance meets the clinical needs. Methods according to the EP5-A2 EP5-A2 EP7-A2 EP-17A document recommended by American Association of Clinical and Laboratory Standardization (CLSI) and the YY/T0654-2008 document of the Medical practice Standard of the people's Republic of China, 16 routine biochemical items were used to measure the precision of the BS-820 automatic biochemical instrument test system of Mayre Company. Linear range, anti-interference ability, sensitivity and carrying pollution rate for performance evaluation. Results the results of evaluation and analysis conducted by BS-820 system showed that the precision of all the items was up to standard. All the 15 biochemical items showed a good linear relationship in the range of test, and the correlation coefficient r 鈮，

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