抗核抗体荧光免疫检测质量控制方法的建立和应用

Establishment and application of the quality control method for ANA detected by fluoimmunoassay

目的 研究荧光强度分析法检测抗核抗体 (ANA)的质量控制方法和质量控制标准及 ,并探讨其应用价值。方法 平行检测质控品 36次 ,分析其荧光强度值 ( x± 2s)和变异系数 (CV % ) ;以质控品荧光强度值在 x± 2s范围内为质量控制标准 ,在 3种荧光显微镜条件 (激发光和采图曝光时间不同 )下检测 1 0 0 0份ANA阳性血清的荧光强度 ,并进行对比分析。同一质控标准下分别用血清稀释法和荧光强度分析法检测 30 0 0份ANA阳性病人血清 ,比较两种方法的符合率 ,评估该质控方法的可靠性。结果 质控品的荧光强度值和CV分别为 1 0 6 6± 9 7和 4 6 %。在此质控标准下 ,1 0 0 0份ANA阳性血清在 3种荧光显微镜情况下的荧光强度值的差异无显著性 (P >0 0 5 ) ;30 0 0份ANA阳性标本 ,用两种方法检测的总符合率为 99 4 % ,其中均质斑点型为 99 8% (998/ 1 0 0 0 )、均质型为 99 5 % (995 / 1 0 0 0 )、斑点型为 99 0 % (990 / 1 0 0 0 )。结论 用定值的质控品控制各个实验室的ANA检测结果 ,可以排除因荧光显微镜等实验条件的差异所导致的误差 ,使实验室间ANA结果准确可靠 ,具有可比性 。

Objective To establish a quality control method and standard of ANA detected by fluorescence density analysis assay and evaluate its application Methods The quality control sera were parallel tested for 36 times, then its fluorescence density( ±2s ) and variance of coefficient( CV %) were analyzed Using the fluorescence density of quality control sera within ±2s as standard, we detected 1 000 ANA positive sera under three condition of fluorescence microscopy(different in exciton light and image exposure time) and analyzed the data Under the same quality control standard, 3 000 ANA positive sera were detected by two methods (serum diluted method and fluorescence density analysis assay) and analyzed on the consistent rate Results The fluorescence density of quality control sera and variance of coefficient were 106 6±9 7 and 4 6%, respectively Using this quality control standard, the fluorescence density of 1 000 ANA positive sera have no significance difference under three fluorescence microscopy condition( P >0 05)and the consistence rate of 3 000 sera tested by two methods were 99 4% totally, including 99 8%(mixture of speckled and homogeneous), 99 5%( homogeneous) and 99 0%( speckled), respectively Conclusion The difference of ANA results between laboratory caused by test condition such as fluorescence microscopy could be eliminated by using quality control with known fluorescence density So the ANA results may be more precise, reliable and comparable We could, thereby, holisticly improve the quality of ANA detection