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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 use different analytical quality requirements and explore the differences in the comparability verification of the multi-system differential testing and alignment schemes for hematology analysis and to establish the appropriate analytical quality standards in the laboratory. Methods According to WS / T 407-2012 Guidelines for the Comparability Test of Quantitative Test Results in Medical Institutions, a method of range test was developed. According to WS / T 406-2012 “Quality Requirements of Clinical Hematology Tests in General Project” Laboratory Improvement Amendment 88 (CLIA’-88), GB / T 20470-2006 “Clinical Laboratory Room Quality Evaluation Requirements” and biological variation of different sources of analysis of quality requirements of the design of the corresponding analysis of quality requirements standards. Results When the standards designed by WS / T 406-2012, CLIA’-88 and GB / T 20470-2006 were used as the analytical quality requirements, only the results of the low concentration level of the three HBC, PLT and HCT projects failed to pass. Other results All passed; Appropriate revision of low-level concentration of analytical quality requirements, all results through the consistency verification. When biological variation was used as the analytical quality requirement, the results of WBC 3 concentration levels and HBG medium and high concentration levels were passed, while other results were not passed. Conclusions The quality requirements of biological variation analysis are relatively strict. Using WS / T406-2012 “quality requirements of routine clinical analysis of hematology test” and GB / T 20470-2006 “quality requirements of clinical laboratory rooms”, taking full account of low concentration The suitability of the quality requirements and the development of a suitable analytical quality standard in the laboratory are important elements of the laboratory comparability verification program.