Performance verification of LIAISON chemiluminescence immunity analyzer / 国际检验医学杂志

ABSTRACT

Objective To verify the performance of LIAISON chemiluminescence immunoassay analyzer in the prenatal screening for TORCH .Methods Reference to the US Institute of Clinical and Laboratory Stand-ards(NCCLS) series of documents and literature and combining with actual work ,we designed the verification program ,and tested and evaluated the LIAISON chemiluminescent immunoassay systems for the measurement precision ,accuracy ,linearity analysis ,clinical reportable range and biological reference intervals of Tox IgG , Tox IgM ,Rub IgG ,Rub IgM ,CMV IgG ,CMV IgM ,HSV IgG ,HSV IgM .We also compared the results with analysis performance provided by manufacturers (Italy LIAISON ) or recognized quality indicators .Results Intra-assay imprecision CV values were between 3 .58％ -7 .03％ ,which were less than the predetermined range;inter-assay imprecision CV values were between 3 .13％ -10 .73％ .Linear range validation regression coefficients a values were between 0 .97 -1 .03 and r2 >0 .95 .The linear relationship met the requirements . Both biological reference interval and reportable range meet the requirements .Conclusion The performance of LIAISON chemiluminescence immunoassay detection system satisfied the clinical requirements ,and the meas-urement results had advantages of high sensitivity ,specificity ,stability ,wide detection range ,good accuracy and repeatability ,which was suitable for clinical application .