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目的通过肿瘤标志物室间质量评价活动,提高全省医疗机构肿瘤标志物的检测质量和各临床实验室间检测结果的可比性。方法通过定期向全省参评实验室寄发质控样品,要求各参评实验室在规定的时间内分别检测甲胎蛋白(AFP)、癌胚抗原(CEA)、前列腺特异性抗原(PSA)、糖抗原(CA)153、CA125、CA199、β-人绒毛膜促性腺激素(β-HCG)、β2-微球蛋白(β2-MG)、铁蛋白9个项目,其中β-HCG、β2-MG、铁蛋白不作评价,按试剂分组统计结果作出评价。结果2年共计发放12支质控品。2004年有50家参评单位,优秀率为40.0%,总合格率为58.0%;2005年有99家参评单位,优秀率为51.5%,总合格率为63.7%。按试剂分组统计变异系数(CV)>50%的共有30组。结论我省2年来的肿瘤标志物室间质量评价的结果显示,各实验室对质控品的测定结果离散度大,各实验室间的检测结果的可比性不理想。其原因是目前各厂家试剂的量值溯源、定标的标准不尽相同,因此选择可靠的方法,选用优质的试剂和规范的实验操作,才能提高肿瘤标志物的检测质量和各实验室间检测结果的可比性,为临床提供可靠的检测信息。
Objective To improve the quality of detection of tumor markers in medical institutions in the province and the comparability of the results of clinical laboratory tests through the evaluation of the quality of tumor markers inter-laboratory. Methods By regularly sending quality control samples to laboratories in the province, the laboratories were asked to test the levels of AFP, CEA, PSA, There were 9 items of CA125, CA125, CA199, β-HCG, β2-microglobulin and ferritin, among which β-HCG, Ferritin is not evaluated, according to the results of reagent grouping evaluation. The results of 2 years a total of 12 quality control release. In 2004, there were 50 participating units, with a good rate of 40.0% and a total passing rate of 58.0%. In 2005, there were 99 participating units with a good rate of 51.5% and a total pass rate of 63.7%. By reagent group statistical coefficient of variation (CV)> 50% of a total of 30 groups. Conclusion The results of laboratory quality evaluation of tumor markers in two years in our province show that the discrepancies of the test results of quality control products in various laboratories are large and the comparability of test results among different laboratories is not satisfactory. The reason is that the current manufacturers of traceable reagents, calibration standards vary, so choose a reliable method, the selection of high quality reagents and standardized experimental operation, in order to improve the quality of the detection of tumor markers and the inter-laboratory testing The comparability of results provides clinically reliable testing information.