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目的 调查全国血铅(blood lead level,BLL)检测实验室的室内质量控制的精密度现状,并与原卫生部发布的相关文件所给出的要求进行比较,提出改进措施。方法 采用基于Web方式的室间质量评价(external quality assessment,EQA)软件系统,采用2014年参加全国血铅室间质量评价计划的实验室的室内质量控制数据,包括当月(2014年2月)和累积的变异系数,使用的方法、仪器以及其他室内质量控制相关信息等。使用Microsoft Excel2007和SPSS13.0对数据进行分析,根据原卫生部发布的《血铅临床检验技术规范》,计算血铅项目的室内质量控制变异系数的通过率,并且比较不同浓度水平和不同检测系统间的通过率是否存在差异,使用χ2检验,双侧α=0.05为检验水准。结果 共427家单位回报了有效结果。其中120家实验室还上报了第二个批号的室内质控数据。浓度范围在20~100μg/L时,当月通过率为88.07%,累计通过率为88.82%;≥100μg/L时,当月通过率为85.26%,累计通过率为81.78%。目前我国血铅检测主要为A、B、C三个检测系统,除系统A累积变异系数外,同一检测系统不同分析结果浓度范围的通过率差异无统计学意义(P>0.05)。不同检测系统间当月和累积的变异系数,在不同分析结果浓度中的通过率均差异无统计学意义(P>0.05)。结论 血铅检测项目实验室内精密度水平直接关系着检验结果的质量水平。通过对当月和累积的室内质量控制数据的变异系数的监测,并将室内质量控制数据计算的变异系数与相关要求进行比较,可以评价该检测系统的不精密度水平是否满足规定的质量要求,为实验室间结果的可比性检验提供精密度的信息。
Objective To investigate the precision status of indoor quality control in the blood lead level (BLL) testing laboratory in the whole country and compare with the requirements given by the relevant documents issued by the former Ministry of Health to propose improvement measures. Methods Based on the Web-based external quality assessment (EQA) software system, laboratory quality control data of laboratories participating in the national blood lead-lead inter-laboratory quality assessment program in 2014 were adopted, including the current month (February 2014) and Cumulative coefficient of variation, methods used, equipment and other indoor quality control related information. Using Microsoft Excel2007 and SPSS13.0 to analyze the data, according to the “Blood Lead Clinical Testing Technical Specification” issued by the former Ministry of Health, the pass rate of indoor quality control coefficient of variation of blood lead project was calculated and compared with different concentration levels and different detection systems Between the adoption rate is there any difference, using the χ2 test, bilateral α = 0.05 for the test level. A total of 427 units reported valid results. 120 laboratories also reported the second batch of indoor quality control data. When the concentration was in the range of 20-100μg / L, the passage rate in the month was 88.07% and the cumulative passage rate was 88.82%. When it was ≥100μg / L, the passage rate in the month was 85.26% and the cumulative passage rate was 81.78%. At present, the detection of blood lead in our country mainly consists of three detection systems, A, B and C. There is no significant difference in the pass rates of different analytical results in the same detection system except the cumulative coefficient of variation of system A (P> 0.05). There was no significant difference in the passing rate between the different detection systems in the month and the cumulative coefficient of variation in different analysis results (P> 0.05). Conclusion The level of precision in the laboratory of blood lead test is directly related to the quality of test results. Through the monitoring of the coefficient of variation of the indoor and outdoor quality control data of the current month and the comparison of the coefficient of variation calculated from the indoor quality control data and the related requirements, it can be evaluated whether the imprecision level of the detection system meets the stipulated quality requirements. The comparability of laboratory results provides information on the precision.