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

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