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目的 通过对新生儿疾病筛查实验室检测苯丙氨酸和促甲状腺素开展室间质量评价工作 ,了解中国目前新生儿疾病筛查实验室苯丙氨酸和促甲状腺素检测能力。方法 参照美国疾病控制中心新生儿疾病筛查质量保证计划 ,建立中国新生儿疾病筛查实验室苯丙氨酸和促甲状腺素检测的室间质量评价方案。通过每年 3次 ,每次 5个样本向新生儿疾病筛查实验室邮寄质控血片 ,实验室对其检测然后将其结果回报给室间质量评价组织者 ,组织者对所有回报的结果进行统计分析 ,作出实验室检测水平的评价。结果 2 0 0 1年参加室间质评的单位数为 2 9家。促甲状腺素测定方法分别为时间分辨荧光免疫法 (占 4 8 1% ) ,其平均实验室间变异系数为 12 2 % ;酶联免疫吸附法 (占 2 9 6 % ) ,其平均实验室间变异系数为 33 5 % ;荧光酶免疫法 (占 2 2 2 % ) ,平均实验室间变异系数为 35 9%。苯丙氨酸测定方法分别为细菌抑制法 (占 5 8 6 % ) ,平均实验室间变异系数为 2 3 8% ;荧光法 (占 4 1 4 % ) ,平均实验室间变异系数为15 4 %。结论 开展全国新生儿疾病筛查实验室苯丙氨酸和促甲状腺素检测室间质量评价 ,有助于发现新生儿疾病筛查实验室检测中存在的问题 ,利于提高新生儿疾病筛查检测质量水平。
OBJECTIVE To understand the phenylalanine and thyrotropin-sensing capabilities of neonatal screening laboratories in China by conducting an inter-laboratory quality assessment of phenylalanine and thyrotropin in neonatal screening laboratories. Methods Reference to the United States Centers for Disease Control and Prevention screening of neonatal disease quality assurance program to establish China Neonatal Screening Laboratory phenylalanine and thyroxine testing room quality evaluation program. Through the annual 3 times, each of 5 samples to the Neonatal Disease Screening Laboratory mail quality control film, the laboratory test it and then return the results to room quality evaluation organizers, the organizers of the results of all the rewards Statistical analysis, make laboratory evaluation of the level of evaluation. Results The number of units participating in inter-office quality assessment in 2001 was 29. Thyrotropin determination methods were time-resolved fluorescence immunoassay (481%), the average inter-laboratory coefficient of variation was 12 2%; enzyme-linked immunosorbent assay (296%), the average between the laboratories The coefficient of variation was 33.5%, while the enzyme-linked immunosorbent assay (22.2%) showed an average inter-laboratory coefficient of variation of 35.9%. The phenylalanine method was bacterial inhibition (accounting for 58.6%), the average inter-laboratory coefficient of variation was 23.8%, the fluorescence method (41.4%) and the average inter-laboratory variation coefficient was 15 4 %. Conclusion Carrying out the inter-laboratory quality assessment of phenylalanine and thyrotropin in the national neonatal screening laboratory can help to find out the problems existing in the screening of neonatal screening laboratories and improve the screening quality of newborn screening Level.