全国同型半胱氨酸检测室间质量评价结果分析

China National External Quality Assessment for Homocysteine

目的依据《医疗机构临床实验室管理办法》（卫医发（2006]73号），加强临床检测项目的质量管理。通过开展同型半胱氨酸室间质量评价工作，了解我国目前同型半胱氨酸实验室的检测能力。方法参照中华人民共和国国家标准GB／T20470—2006《临床实验室室间质量评价要求》，建立我国同型半胱氨酸检测的室间质量评价方案。通过每年1次，每次5个样本向参加质评的实验室邮寄质控物，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，做出实验室检测水平的评价。结果2008年按照实际回报数据的41家进行统计分析，循环酶法占51．22％，其实验室闻平均变异系数为17．47％；荧光偏振免疫检测（FPIA）法占29．27％，其实验室同平均变异系数为22．02％；酶联免疫法占4．88％，其实验室间平均变异系数为13．99％；其它方法组占14．63％，实验室阐平均变异系数为15．16％。2009年按照实际回报数据的70家进行统计分析，循环酶法占54．05％，其实验室间平均变异系数为19．78％；荧光偏振免疫检测（FPIA）法占22．97％，其实验室间平均变异系数为15．90％；酶联免疫法占2．70％，其实验室间平均变异系数为21．46％；其它方法组占20．28％，实验室间平均变异系数为24．50％。结论开展全国同型半胱氨酸检测室间质量评价，有助于发现同型半胱氨酸实验室检测中存在的问题，利于提高同型半胱氨酸检测质量水平。

Objective To evaluate the compentence of homocysteine measurement in Homocysteine by use of establishment of national external quality assessment（EQA） in Homocysteine. Methods National external quality assessment scheme in measurement of Homoeysteine was established in Homocysteine laboratory, according to China National Standard GB/ T20470-2006 the requirements for external quality assessment in clinical laboratory. Five spots would be distributed by EQA organizer to participating laboratory each time. and one times each year. After performing the requested tests ,laboratories returned their results to the EQA organizer,and a statistical analysis was performed to determine global and methodspecific means and standard deviations of results for each analyte as well as performance assessment of individual laboratories. Results 41 laboratories participated the EQA scheme in Homocysteine in 2008 and 70 laboratories participated the EQA scheme in Homocysteine in 2009. The method of Homocystelne in 2008：enzymatic cycling assay （51.22%）,CVI was 17. 47% ;fluorescence polarization immunoassay（FPIA） （29.27%） ,CVinter was 22. 02% ;euzymelinked immunosorbent assay（ELISA）（4.88 %）,CVinter was 13. 99%;other methods of group （14. 63%）,CVinter was 15.16%. The method of Homocysteine in 2009：enzymatic cycling assay （54.05%）,average of interlaboratory coefficient of variation CVinter was 19.78% ;fluorescence polarization immunoassay（FPIA） （22. 97%）,CVI was 15. 90%;euzymelinked immunosorbent assay（ELISA） （2.70%） ,CVinter was 21.46% ;other methods of group （20. 28%） ,CVinter was 24.50%. Conclusion The recommended external quality assessment is useful to find out the problems in homocysteine measurement and improve the quality of Homocysteine.