Analytical performance of roche 2010 immunoassay system in detecting AFP

OBJECTIVE To validate the basic performance of Roche 2010 Immunoassay System in detecting fetoprotein(AFP).METHODS The precision,accuracy,reportable range and reference interval of the Roche 2012 Immunoassay System in detecting AFP were analyzed.RESULTS The results of within-run precisions were 0.28 IU/ml of 11.90 IU/ml AFP level and 2.85 IU/ml of 237.23 IU/ml AFP level.The total precisions were 0.45 IU/ml of 11.90 IU/ml AFP level and 3.50 IU/ml of 237.23 IU/ml AFP level.There results were consistent with manufacturer's instruction;The relative bias between the measured results and the target values was less than 5%,and the relative bias between the measured results and the EQA control samples at five levels was-0.41%-6.61%;measurement range was 0.514-992.7 IU/ml within manufacturer's liner range.Clinical reportable range was 0.514-158 832 IU/ml;Reference interval was 0.0-5.8IU/ml,which was consistent with manufacturer's instruction.CONCLUSION The Roche 2010 Immunoassay System has good precision performance the electrochemiluminescence immunoassay system in detecting AFP consistency in detecting AFP;The reference interval of manufacturer's instruction can be received;The verification procedure and experimental method are simple and practical.