發(fā)布時間：2018-08-01 21:15

【摘要】：目的評價趨勢分析方法用于HIV血液篩查診斷試劑的質(zhì)量穩(wěn)定性。方法以國產(chǎn)3個廠家(A、B、C)的HIV血液篩查診斷試劑作為研究對象,采用各試劑連續(xù)批次檢測靈敏度界值參考品S4、HIV-1型中等反應(yīng)性樣品(P18)、HIV-2型低反應(yīng)性樣品(P19)、陰性參考品的陰性符合比例,繪制Levey-Jennings趨勢分析質(zhì)控圖,計算每個樣品的檢測平均值(mean)和標(biāo)準(zhǔn)差(SD),以mean±2 SD作為警戒限,mean±3 SD作為行動限,觀察各廠家診斷試劑的檢測指標(biāo)變化趨勢。結(jié)果試劑A質(zhì)量穩(wěn)定,S4、P18和P19樣品的檢測結(jié)果均未見超過行動限的批次;試劑B和C的陰性參考品陰性符合比例的變化均呈現(xiàn)在趨勢分析中,試劑B檢測P18樣品出現(xiàn)2個批次檢測結(jié)果超過行動限,試劑C連續(xù)8批S4、P18和P19樣品的檢測結(jié)果在均值同側(cè)。在37℃加速穩(wěn)定性試驗中,32批試劑C分別檢測P18、P19和S4樣品的變化趨勢一致;S4樣品37℃加速穩(wěn)定性及4℃穩(wěn)定性檢測結(jié)果差異有統(tǒng)計學(xué)意義(P0.01);企業(yè)和中檢院S4、P18和P19樣品37℃加速穩(wěn)定性結(jié)果差異均有統(tǒng)計學(xué)意義(P均0.01)。結(jié)論我國血液篩查試劑質(zhì)量穩(wěn)定,趨勢分析可發(fā)現(xiàn)試劑質(zhì)量變化,可嘗試用于HIV體外診斷試劑的穩(wěn)定性評價。
[Abstract]:Objective to evaluate the quality stability of HIV blood screening diagnostic reagent by trend analysis. Methods the HIV blood screening and diagnosis reagents from three domestic manufacturers (Agna BU C) were used as the research object. The sensitivity limit of the reagents S4H4 HIV-1 medium reactive sample (P18) and HIV-2 low reactive sample (P19) were determined by successive batches of the reagents. The negative rate of the negative reference sample was consistent with that of the negative reference material. The Levey-Jennings trend analysis quality control chart was drawn, and the detection average (mean) and standard deviation (SD), of each sample were calculated. The warning limit of mean 鹵2SD was taken as the warning limit and mean 鹵3SD as the action limit. Results the quality stability of reagent A, S _ 4, P _ (18) and P _ (19) did not exceed the action limit, and the negative reference of reagent B and C showed the change of negative coincidence ratio in trend analysis. The results of two batches of reagent B for P18 samples exceeded the action limit, and the results of reagent C for 8 successive batches of S4, P18 and P19 samples were on the same side. In the 37 鈩，

本文編號：2158621