临床实验室多台生化分析仪极差法比对中分析质量要求研究
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摘要
目的比较生物学变异、实验室内长期不精密度及允许变异系数(CV)在极差法比对中的应用确定合适的判断标准。方法按照WS/T 407—2012制定极差法比对方案。用新鲜血清制作标本,高、低2个水平,在3台生化分析仪上检测19个常规生化项目。结果 19个常规生化项目同一水平的实验室内长期不精密度及合成CV均<允许CV,50%的合成CV>1/3个体内生物变异;每个项目的比对偏差都<允许CV;有50%的比对偏差>1/3个体内生物变异;20%的比对偏差>临界极差。结论允许CV最适合作为判断标准,但属于异类相比(极差和标准差);中间精密度临界极差是同类相比,但稍严格,作为标准可与允许CV联合使用;1/3个体内生物变异属于异类相比且较严格,不适合作为判断标准。
Objective To evaluate biological variations,laboratory internal long-term imprecision and allowable coefficient of variation(CV) in range comparison,and to determine appropriate criteria for judgement. Methods According to WS/T 407—2012,the scheme of range comparison was established. With high-level and low-level of patients' fresh sera,19 biochemical items were determined by 3 biochemical instruments. Results For the 19 biochemical items,laboratory internal long-term imprecision and combined CV at the same level were < allowable CV,and 50% combined CV was >1/3 biological variation. Each comparison deviation was < allowable CV,and 50% comparison deviation was >1/3 biological variation. The 20% comparison deviation was > critical range. Conclusions Allowable CV can be used as a criterion for judgement,which is non-congener comparison(range comparison and standard deviation). The critical range belongs to congener comparison,which is strict slightly and can be used as a criterion for the combined usage with allowable CV. 1/3 Biological variation belongs to congener comparison and is too strict to be used as a criterion for judgement.
Objective To evaluate biological variations,laboratory internal long-term imprecision and allowable coefficient of variation(CV) in range comparison,and to determine appropriate criteria for judgement. Methods According to WS/T 407—2012,the scheme of range comparison was established. With high-level and low-level of patients' fresh sera,19 biochemical items were determined by 3 biochemical instruments. Results For the 19 biochemical items,laboratory internal long-term imprecision and combined CV at the same level were < allowable CV,and 50% combined CV was >1/3 biological variation. Each comparison deviation was < allowable CV,and 50% comparison deviation was >1/3 biological variation. The 20% comparison deviation was > critical range. Conclusions Allowable CV can be used as a criterion for judgement,which is non-congener comparison(range comparison and standard deviation). The critical range belongs to congener comparison,which is strict slightly and can be used as a criterion for the combined usage with allowable CV. 1/3 Biological variation belongs to congener comparison and is too strict to be used as a criterion for judgement.
引文
[1]中华人民共和国卫生部.WS/T 407—2012医疗机构内定量检验结果的可比性验证指南[S].北京:中国标准出版社,2012.
[2]朱翔,韩凌飞,谢萍,等.多台全自动血液分析仪检验结果的可比性验证[J].检验医学,2015,30(3):240-242.
[3]赵海建,王萌,张传宝,等.同一医院内血清葡萄糖在两台不同检测系统上可比性验证[J].现代检验医学杂志,2013,28(3):158-159.
[4]中华人民共和国卫生部.WS/T 403—2012临床生物化学检验常规项目分析质量指标[S].北京:中国标准出版社,2013.
[5]中华人民共和国国家质量监督检验检疫总局.GB/T16306—2008声称质量水平复检与复验的评定程序[S].北京:中国标准出版社,2008.
[6]中华人民共和国国家质量监督检验检疫总局.GB/T 6379.6—2009测量方法与结果的准确度[S].北京:中国标准出版社,2008.
[2]朱翔,韩凌飞,谢萍,等.多台全自动血液分析仪检验结果的可比性验证[J].检验医学,2015,30(3):240-242.
[3]赵海建,王萌,张传宝,等.同一医院内血清葡萄糖在两台不同检测系统上可比性验证[J].现代检验医学杂志,2013,28(3):158-159.
[4]中华人民共和国卫生部.WS/T 403—2012临床生物化学检验常规项目分析质量指标[S].北京:中国标准出版社,2013.
[5]中华人民共和国国家质量监督检验检疫总局.GB/T16306—2008声称质量水平复检与复验的评定程序[S].北京:中国标准出版社,2008.
[6]中华人民共和国国家质量监督检验检疫总局.GB/T 6379.6—2009测量方法与结果的准确度[S].北京:中国标准出版社,2008.