谷氨酸脱羧酶抗体放射配体检测法的质量控制  

Quality control of radioligand assay for glutamic acid decarboxylase antibody

作　　者：黄干[1] 周智广[1] 彭健[1] 颜湘[1] 杨琳[1] 李霞[1] 王建平[1] 

机构地区：[1]中南大学湘雅二医院代谢内分泌研究所,长沙410011

出　　处：《湖南医科大学学报》2003年第6期597-600,共4页Bulletin of Hunan Medical University

基　　金：国家自然科学基金项目 ( 3 93 70 3 43 ) ;卫生部优秀青年科技人才基金项目 (Q942 0 )

摘　　要：目的 :为谷氨酸脱羧酶抗体 (GAD Ab)的放射配体检测法提供质量控制。方法 :采用放射配体法检测 83批GAD Ab ,对其质量控制进行回顾性分析与总结。结果 :本方法批内CV为 4 .9%～ 8.3% ,批间CV 7.1%～10 .8% ;以信 /噪比 (S/N)≥ 15作为检测成功标准 ,83批检测中合格 6 7批 (80 .7% ) ,失败 16批 (19.3% ) ,其中夏季检测失败率 (38.5 % ,10 / 2 6 )明显高于冬季 (4 .8% ,1/ 2 1) (P <0 .0 5 ) ,且夏季S/N均值明显低于冬季 (14 .1± 7.3vs .2 1.5± 5 .2 ,P <0 .0 1) ;在失败的批次中 ,由TBST缓冲液引起的占 6 8.8% (11/ 16 ) ,其中因缓冲液温度过高引起的占 5 0 % (8/ 16 ) ,其他原因有体外转录翻译试剂失效等。结论 :放射配体法检测GAD Ab的影响因素 ,特别是TBST缓冲液 ,应引起操作者重视并加以控制 ,以确保结果稳定可靠。Objective To supply the quality control for glutamic acid decarboxylase antibody (GAD-Ab) measurement using radioligand assay. Methods The quality control of GAD-Ab determined with radioligand assay in 83 batches was analyzed. Results The intra-assay coefficient of variation (CV) was 4.3%～8.3% and the inter-assay CV was 7.1%～10.8%. A ratio of signal to noise (S/N) with 15 or more was defined as a valid measurement. Of the 83 batches, 67 batches (80.7%) met with the standard and the other 16 (19.3%) were not qualified. When the results were analyzed according to the season, the failure rate in summer was significantly higher than that in winter (38.5% vs. 4.8%, P<0.05). In addition, the mean value of S/N in summer was significantly lower than that in winter ( 14.1±7.3 vs. 21.5±5.2 , P<0.01). Among the failed batches, 68.8% (11/16) was caused by TBST buffer and 50% (8/16) due to the increased temperature of TBST buffer. Other causes for the failure included the invalidation of reagents for in vitro transcription and translation. Conclusion TBST buffer and other influential factors of radioligand assay in determining GAD-Ab, should be controlled strictly to ensure a reliable and repeatable result.

关 键 词：谷氨酸脱羧酶 自身抗体 放射配体法 质量控制 

分 类 号：R817.4[医药卫生—影像医学与核医学]