Investigation of the analytical measurement range and clinical reportable range of chemiluminescence immunoassay in the detection of THCG

Objective To investigate the analytical measurement range(AMR) and establish the clinical reportable range(CRR) of SIEMENS Centaur cp system in the detection of THCG.Methods Samples with equal interval,proportional prepared with samples at concent ration levels,exceeding the low and high concent ration limits claimed by manufacture,were detected twice each.The AMR claimed by manufacture was evaluated and verified by polynomial regression analysis.Three samples,at high concentration level and within the AMR,diluted to different dilution ratio,were detected,and the dilution recovery rate was calculated to determine the max allowable dilution rate and establish CRR by combining functional sensitivity.All of the detection and analysis mentioned above were performed according to clinical and laboratory standard institute(CLSI) document EP6-A.Results The AMR of THCG was 1.7-995.0 mIU/mL,the max allowable dilution rate was 1∶200,the CRR was 2.6-199 000 mIU/mL.Conclusion There can be fine linearity within the AMR,claimed by manufacture.SIEMENS Centaur cp system in the detection of THCG and the CRR established in this research can meet the needs of clinical laboratory.