Abstract: 【Objective】 To investigate the test capability of 17-hydroxyprogesterone (17-OHP) for newborn screening laboratories. 【Methods】 5 lots of 17-OHP quality control material (dry blood filter paper) had been sent to 38 newborn screening laboratories and the feedback information included:measurement values,diagnostic results (positive-negative),resources and information of cut off value.After statistic analysis,test capabilities of every attended laboratory were evaluated. 【Results】 The valid feedback rate was 81.6% (31/38) and stratified study indicated that 26 laboratories used time-resolved immunofluorescence assay.The ranges of the Coefficient of variations (CVs) and robust CVs for all the 5 lots were from 13.57% to 25.83% and 15.99% to 24.65% respectively; the total acceptable rate of diagnostic results (positive-negative) and measurement values (nmol/L in whole blood) were 90.3% and 83.9%,respectively.The cut off value for most laboratories in this study was 30 nmol/L in whole blood meanwhile 64.5% of the resource of reference value was from reagent manufacturer `s instructions. 【Conclusions】 Because of the large CVs and low pass rate by conducting 17-OHP external quality assessment program in China,the test capability of newborn screening laboratories could be improved and the incidence of children with disabilities would be decreased.

Key words: 17-hydroxyprogesterone, interlaboratory quality survey, coefficient of variation, acceptable rate, cut off

摘要： 【目的】 了解目前我国新生儿遗传代谢病筛查实验室17-羟孕酮的检测水平现状。 【方法】 向38家新筛实验室邮寄5个批号的17-羟孕酮质控干血斑,实验室需要回报17-羟孕酮测定值、临床判断(阴阳性)、切值来源和切值信息,组织者对所有回报的结果进行统计分析,做出实验室检测水平的评价。 【结果】 参加本次调查的单位为38家,收到回报31家,回报率为81.6%。 26家实验室采用了时间分辨免疫荧光分析法,该方法5个批号的变异系数在13.57%~25.83%之间,稳健变异系数分布在15.99%~24.65%之间;17-羟孕酮临床判断(阴阳性)和测定值(nmol/L全血)汇总及格率分别为90.3%和83.9%。调查的筛查实验室切值多采用30 nmol/L全血,64.5%切值来源于试剂厂家说明书。 【结论】 本次筛查实验室间调查结果的变异系数稍大,其定量测定结果的可接受率稍低。通过开展全国新生儿遗传代谢病筛查17-羟孕酮质评计划来提高全国新筛实验室临床检测质量水平,减低残疾儿童的发生率。

关键词: 17-羟孕酮, 室间质量调查, 变异系数, 及格率, 切值