不同分析质量要求在血细胞分析多系统极差检验可比性验证方案中的应用

Application of different analytic quality requirements in comparable validation scheme of blood cell analysis multi-system

目的使用不同分析质量要求,探讨其在血细胞分析多系统极差检验比对方案可比性验证中的差异,建立实验室适宜的分析质量标准。方法参照WS/T 407-2012《医疗机构内定量检验结果的可比性验证指南》制定极差检验比对方法,依据WS/T 406-2012《临床血液学检验常规项目分析质量要求》、美国临床实验室改进修正案88(CLIA′-88)、GB/T 20470-2006《临床实验室室间质量评价要求》及生物学变异等不同来源的分析质量要求设计相应的分析质量要求标准。结果使用WS/T 406-2012、CLIA′-88及GB/T 20470-2006设计的标准作为分析质量要求时,仅HBC、PLT、HCT 3个项目低浓度水平的比对结果未通过,其他结果均通过;适当修订低值浓度的分析质量要求,所有结果通过一致性验证。应用生物学变异作为分析质量要求时,WBC 3个浓度水平及HBG中、高浓度水平的比对结果通过,其他结果均未通过。结论生物学变异分析质量要求相对苛严;使用WS/T406-2012《临床血液学检验常规项目分析质量要求》及GB/T 20470-2006《临床实验室室间质量评价要求》,充分考虑低浓度质量要求的适宜性,制定实验室合适的分析质量标准,是实验室可比性验证方案的重要内容。

Objective To explore the differences of using different analytic quality requirements in the comparable validation of blood cell analysis multi-system range test comparable schemes for establishing appropriate analysis quality standards for laboratory.Methods According to WS/T 407-2012 Guideline for Comparability Verification of Quantitative Results in Medical Institution,the range test comparable method was established.According to different sources of analytic quality requirements from the WS/T406-2012 Analysis Quality Requirements of Clinical Hematological Detection Routine Items,the US Clinical Laboratory Improvement Amendment（88）,GB/T 20470-2006 Requirements of External Quality Assessment for Clinical Laboratories and biological variations,corresponding analysis quality requirements standard was designed.Results With the standards designed by using WS/T 406-2012,CLIA′-88 and GB/T 20470-2006 as the analysis quality requirements,only the comparison results of low concentration levels in 3items of HBC,PLT and HCT were not passed,while other results all were passed;all results passed the consistency verification by suitably revising the analytic quality requirements of low value concentrations.With the biological variations as the analysis quality requirement,the comparison results in WBC three concentration levels,and HBG high and low concentration levels were passed,but other results were not passed.Conclusion The biological variations analytical quality requirements are relative demanding.Using WS/T 406-2012 Analysis Quality Requirements of Clinical Hematological Detection Routine Items and GB/T 20470-2006 Requirements of External Quality Assessment for Clinical Laboratories,fully considering the suitability of low concentration quality requirements and formulating appropriate analysis quality standards of laboratory are the important contents of laboratory comparable validation scheme.