即刻法和Levey-Jennings法在ELISA检测HBsAg中的比较

Comparison Between the Instant Method and the Levey-jennings Method in Detecting HBs Ag by ELISA

目的将2013年8月至2014年4月底每次ELISA法检测HBs Ag试验的前20次质量控制数据分别用即刻法和LeveyJennings法分析,探究这两种方法的优缺点及适用情况。方法对半年的质控数据先用即刻法统计分析,计算得到每组数据的x,CV,s,SI上限及SI下限,并将得到的SI上限,SI下限与SI界值表比较,若SI上限,SI下限均小于n2s,则表明试验在控,若有一值处于n2s和n3s之间,则为告警,若有一值大于n3s,则处于失控,对于失控和告警的数据都需舍去离散程度最大值,并查找原因,重新进行测定。同时对同批号质控物和同试剂的前20次质控数据进行计算得到,s,并以x,x±3s建立质控框架图,将随后数据绘入Levey-Jennings质控图中,大于x+3s或小于x-3s的质控值视为失控状态,需查找原因,重新测量。结果发现有两组数据在即刻法和Levey-Jennings法中呈现出不同的结果。即刻法中告警的数据在Levey-Jennings法中可以处于在控状态,而Levey-Jennings法失控的数据在即刻法中可能在控。结论即刻法和Levey-Jennings法适用不同条件下的检测,对于检测频率较低的样本,即刻法显得更为合适。对于HBs Ag来看,Levey-Jennings法更合适适用。

Objective To explore the advantages and disadvantages of instant method and Levey-Jennings Jennings.Methods The first 20 quality control datas of HBs Ag detected by ELISA from August 2013 to end of April 2014 were analyzed. Data from instant method werestatistically analyzed and calculated,x^-,CV,s,SIupper limitand SI lower limit,and made SIupper limit,and SIlower limitcompare with the SI community. If SIupper limitand SIlower limitwereall less than n2 s,it indicatedthat the test was in control. If a value was between n2 s and n3 s,it indicatedan alarm. If a value was greater than n3 s,it was out of control. For out of control and alarm data,the data of maximum degree of dispersion wereabandoned,found out the reasons,and then measured again. While the former 20 times QC data with the same batch quality control materialand reagents were calculated x^-,s,and,establish quality control frames baesd on x^- ± 3s. The later data were then drawn into Levey-Jennings control chart. When avalue was greater than x^-＋ 3s or less than the control x^--3s,it was considered out of control. There wasa need to find out the reason and remeasure. Results It was found that there were two different results analyzed by instant method and LeveyJennings. The alarm data in instant method may be incontrol state in Levey-Jennings,however,the data out of control in Levey-Jennings may be controlled in the other set. Conclusion Instant method and Levey-Jennings applies in different conditions,for lower frequency of tested samples,instant method is much more appropriate. For HBs Ag,Levey-Jennings method is a better choice.