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目的:探讨甘肃省新生儿疾病筛查中心实验室参加卫生部临床检验中心新生儿疾病筛查实验室室间质量评价5年效果,以确定该室进行检测或测量的能力,及时识别实验室中的问题并制定相应的补救措施。方法:采用DELFIA分析系统和荧光法检测卫生部临床检验中心发的各批室间质量评价(质评)标本的促甲状腺素(TSH)和苯丙氨酸(Phe)数值,分析质评结果。结果:15批75份样本检测,TSH和Phe偏倚分布范围广;检测结果符合率97.33%,临床评估结果符合率96.00%。结论:该实验室室间质评结果在控制限内,5年平均总得分97.34%,累积性能解释为成功;因患者的诊断完全依赖于实验室的诊断,故接受国内对新生儿疾病筛查实验室质量的监控,是对大批量检测标本操作的可信性及实验室稳定性、均一性的有效保障。
Objective: To explore Gansu Province, neonatal screening center laboratories to participate in the Ministry of Health Clinical Laboratory of Neonatal Screening Laboratory quality assessment of 5-year results to determine the room for testing or measurement capabilities, timely identification of laboratories Issue and make the appropriate remedy. Methods: The TSH and Phe values were evaluated by DELFIA analysis system and fluorescence method in each batch of inter-laboratory quality assessment (quality evaluation) specimens issued by the Clinical Laboratory Center of Ministry of Health, and the quality evaluation results were analyzed. Results: The results showed that TSH and Phe were widely distributed in 75 batches of 15 batches. The coincidence rate was 97.33%. The coincidence rate of clinical evaluation was 96.00%. Conclusion: The results of laboratory interlaboratory quality evaluation within the control limits, the average 5-year average score of 97.34%, the cumulative performance is interpreted as successful; because the diagnosis of patients is completely dependent on the laboratory diagnosis, it is accepted domestic screening of neonatal diseases Laboratory quality control, is the credibility of the operation of large quantities of specimens and laboratory stability, uniformity of the effective protection.