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目的:回顾2008~2011年参加卫生部临床检验中心组织的新生儿疾病筛查项目室间质评结果并分析,以了解该项目质控质量。方法:采用酶标法与时间分辨法进行12批60份TSH、Phe样本检测。结果:定量结果评价:60份质评样本中,59份TSH测定值和60份Phe测定值偏倚在允许范围内,1份TSH测定值偏倚≥30%为失控。定性结果评价:60份质评样本中,59份TSH定性反馈结果和60份Phe定性反馈结果通过,1份TSH反馈结果未通过定性判断,符合率分别为98.3%(TSH)和100%(Phe)。结论:回顾分析4年来参评项目数据,对于整体质控工作及科学管理检测质量的提高具有指导价值。
OBJECTIVE: To review the results of inter-laboratory qualitative assessment of neonatal screening programs organized by the Clinical Laboratory of the Ministry of Health from 2008 to 2011 to understand the quality of the quality control of this project. Methods: Twelve batches of 60 samples of TSH and Phe were detected by enzyme-labeled and time-resolved methods. Results: Evaluation of quantitative results: Of the 60 quality evaluation samples, 59 TSH values and 60 Phe values were within the allowable range, and 1 TSH value ≥30% was out of control. Evaluation of Qualitative Results: In the 60 quality evaluation samples, 59 TSH qualitative feedback results and 60 Phe qualitative feedback results were passed. One TSH feedback result failed to pass the qualitative judgment, and the coincidence rates were 98.3% (TSH) and 100% (Phe) ). Conclusion: Retrospective analysis of the participating project data in the past four years is of guiding value to the overall quality control work and the improvement of scientific management and testing quality.