关键词: 17-羟孕酮, 室间质量调查, 变异系数, 及格率, 切值

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