TORCH血清学检测室间质量评价分析

External quality assessment on TORCH immunoassay in China

目的对目前国内临床实验室TORCH血清学检测情况进行评价。方法通过室间质量评价的方式：每年进行2次室间质评，每次发放5支质评样本；要求各临床实验室在规定时间内检测、回报检测结果、所用的检测方法、仪器和试剂；卫生部临床检验中心对各实验室的结果进行统计分析，将结果反馈给各实验室，同时对检测结果、试剂情况进行评价。结果2007年单纯疱疹病毒（HSV）IgM、风疹病毒（Rubella virus）IgM和巨细胞病毒（CMV）IgM3个项目临床实验室检测合格率均达到了80％以上，弓形虫（Toxo）IgM符合率较低，仅53．1％。试剂的使用评价分析显示，不同试剂各个项目的阳性符合率均较低（均小于80％）。相同的试剂在不同的实验室检测得到的样本吸光度（A）值与阳性结果判定值的比值（S／CO值）有很大差异。结论TORCH血清学检测室间质量评价反映出多数实验室得到了满意的成绩（PT≥80），但阳性样本的检出率较低，除试剂的原因，也有实验室工作人员操作方面的原因。

Objective To evaluate performance of the clinical laboratories for detection of TORCH immunoassay. Methods There were 2 times external quality assessment （EQA） for nuclear antibody detection. Each panel consisting of 5 liquid serum samples were distributed. Each participants of the EQA program had to reply the results, the methodological procedure and the kits. All data were analyzed and then provided to all laboratory in our EQA program. Results In 2007, the rate of good response were more than 80% for HSV immunogiobulin-M, Rubella immunoglobulin-M and CMV immunogiobulin-M. Response for Toxo immunogiobulin-M was poor （53.1%）. The sensitivities of the commercial kits were quite low （ 〈 80% ）. Some clinical laboratories using the same kits gave quite different S/CO value. Conclusions A lot of clinical laboratories get good score in TORCH detection external quality program. False negative is the major problem.