Performance Verification of TSH-3 Chemiluminescence Immunoassay

Objective To verify the method performance of TSH-3 chemiluminescence immunoassay.Methods Referring to CLSI evaluation protocols and pertinent literature,combining our actual works,we designed verification procedure and experimental methods.The precision,accuracy,analytical sensitivity,analytical measurement range,clinical reportable range and biotic interval of TSH-3 were verified on the Centaur XP chemiluminescence immunoassay system.Results would be compared with the declaration of the manufacturer.Results The results showed the within,without and between-day inaccuracy were 2.17%,2.14% and 7.98%,6.81%,6.69% respectively.The relative bias were from-3.45% to-1.55%.LLD was 0.005 4 μIU/ml,BLD was between 0.010 2 μIU/ml and 0.015 3 μIU/ml,FS was about 0.017 0 μIU/ml.AMR was(0.005 4～140.613 0) μIU/ml.CRR was(0.015 3～703.065) μIU/ml.Except for 2 specimen′s TSH-3 results were beyond manufacturer′s claimed,35 results were within.Conclusion The performances of the detection system are according with the declaration of the manufacturer and meet the requests of the physicians.