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报告研制了美国Corning644/Na~+ K~+Cl~-国产化配套试剂包替代进口配套试剂包,通过实验结果表明:Na~+,K~+,Cl~-精密度分别为:批内CV值0.68%,0.46%,0.88%;批间CV值0.78%,0.59%,0.96%。回收实验:平均回收率依次是101.6%,99.8%,100.6%。用自制试剂包同时随机测定51份血清标本,经t检验结果三组数据均无显著差异(P>0.05),相关试验(n=51),两种试剂包测定结果比较呈高度相关,Na~+r=0.9462,y=6.8736+0.9514x,K~+r=0.9839,y=0.1560+0.9630x;Cl~-r=0.9310,y=15.4319=0.9534x。自配试剂包稳定,定标通过良好,结果准确可靠,室内、室间质控符合要求,具有显著的经济效益,其质量赶上进口试剂,基本可以取而代之。
Reported the development of the US Corning644 / Na ~ + K ~ + Cl ~ - domestic supporting reagent package instead of imported supporting kit, the experimental results show that: Na ~ +, K ~ +, Cl ~ Value of 0.68%, 0.46%, 0.88%; inter-batch CV value of 0.78%, 0.59%, 0.96%. Recovery experiments: The average recovery rate was 101.6%, 99.8%, 100.6%. There were no significant differences among the three groups (P> 0.05). The correlation test (n = 51) showed that the results of two kinds of reagent kits were highly correlated, and Na ~ + r = 0.9462, y = 6.8736 + 0.9514x, K + r = 0.9839, y = 0.1560 + 0.9630x; Cl ~ -r = 0.9310, y = 15.4319 = 0.9534x. Self-reagent package stability, calibration through a good, accurate and reliable results, indoor and laboratory quality control to meet the requirements, with significant economic benefits, its quality catch up with imported reagents, the basic can be replaced.