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开展试剂产品质量评价 建立试剂管理科学体系 被引量:1

Setting up a Scientific System of Reagent Management by Carrying out Reagent Product Quality Evaluation
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摘要 经国家食品药品监督局批准上市的仪器和试剂,在同种仪器及同种试剂存在一定的差异。本院适时开展了同品种试剂质量比较评价工作。本文进行30例同一静脉血2家血糖仪与生化仪测定结果比较、50例病人同一尿样两家尿液分析仪测定尿糖结果比较。结果2种不同厂家的血糖仪和尿液分析仪的尿糖结果差异显著。作者建议建立医院内试剂质量评价科学体系。确保采购质优的试剂,保证医院检验结果的安全可靠。 Test results may differ greatly in the same sample using the same kind of equipment and agent from dif- ferent manufacturers which had been permitted by State Food and Drug Administration.Test for blood glucose of 30 cases using ACCU-CHEK AdvantageⅡfrom ROCHE or Optium from Medisese Abbott or HITACHI 7600 from HI- TACHI and urine glucose of 50cases using H-300 urine analyzer from Chuangcun or Uritest-500 from Guiling demonstrates that results differ obviously.Based on our tests,we suggest that hospital should set up a scientific sys- tem of reagent quality evaluation as a means to ensure our purchase of good quality reagent for obtaining reliable test results.
出处 《解放军医院管理杂志》 2006年第9期728-729,共2页 Hospital Administration Journal of Chinese People's Liberation Army
关键词 体外诊断试剂 管理 体系 血糖 尿糖 diagnoses agent in vitro managed system blood glucose urine glucose
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