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雅培i2000化学发光仪替代冲洗缓冲液的评价
引用本文:苏根元,胡晓丽,尚晓泓. 雅培i2000化学发光仪替代冲洗缓冲液的评价[J]. 中国医学装备, 2011, 8(6): 19-22
作者姓名:苏根元  胡晓丽  尚晓泓
作者单位:1. 中国中医科学院西苑医院供应处,北京,100091
2. 中国中医科学院西苑医院检验科,北京,100091
摘    要:
目的:对雅培i2000化学发光仪国产替代缓冲液进行评估.方法:(1)使用国产替代冲洗缓冲液进行17个项目不同水平的质控品检测并进行结果分析.(2)依据美国临床实验室标准化委员会(NCCLS)EP9-A2文件要求,通过TSH、HBcAb两个检测项目,就原厂冲洗缓冲液和国产冲洗缓冲液进行比对试验,偏差分析评估.结果:(1)使用国产替代冲洗缓冲液测量17个项目不同水平的质控品,结果全部合格.(2)得出线形回归方程,检测项目促甲状腺激素(TSH)为y=0.9737x+0.0357,r=0.999;乙肝核心抗体(HBcAb)为y=0.9878x-0.057,r=0.998.两种冲洗缓冲液对测量结果无显著性差异.结论:国产缓冲液具有替代原厂配套缓冲液的可能性.

关 键 词:冲洗缓冲液  EP9-A2评价

Evaluation of domestic alternative wash buffer in Abbott i2000 Chemo -luminescence analyzer
SU Gen-yuan,HU Xiao-li,SHANG Xiao-hong. Evaluation of domestic alternative wash buffer in Abbott i2000 Chemo -luminescence analyzer[J]. China Medical Equipment, 2011, 8(6): 19-22
Authors:SU Gen-yuan  HU Xiao-li  SHANG Xiao-hong
Affiliation:SU Gen-yuan,HU Xiao-li,SHANG Xiao-hong Department of Logistics,Xiyuan Hospital,Chinese Academy of Traditional Chinese Medicine,Beijing 100091,China.
Abstract:
Objective:To evaluate the domestic alternative wash buffer in Abbott i2000 chemo -luminescence analyzer.Methods:(1)Quality control materials of 17 items are tested with i2000 chemo-luminescence analyzer using domestic alternative wash buffer instead of the original buffer,and all of the results are analyzed.(2) According to National Committee for Clinical Laboratory Standards(NCCLS) EP9-A2 document,TSH and HBcAb levels of patient samples are test to compare domestic alternative wash buffer with the original...
Keywords:Wash buffer  EP9-A2  Evaluation  
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