Method evaluation and correlation research of human sex hormone-binding globulin

Objective To evaluate the method performance of human sex hormone binding globulin(SHBG),to identify whether it can meet the clinical requirement,to set up the reference range of SHBG and to find out the correlation of SHBG to testosterone or estradiol.Methods The commercial SHBG reagent kit was used to assay SHBG in serum and its precision,linearity evaluation and the low limited detection according to the CLSI EP5-A,EP6-P files.To set up the SHBG reference range in lab.To analyze the correlation of testosterone or estradiol to SHBG.Results The within-run variation for middle and low values was 2.5% and 2.16%.The between-day variation for middle and low values was 4.33% and 2.63%.Linearity evaluation:0.80-183.60 nmol/L.The reference range of male under 60-year-old was 8.76-61.44 nmol/L.The reference range of male over 60-year-old was 8.76-61.44 nmol/L,The reference range of female was 10.26-129.94 nmol/L.There was no correlation of the total testosterone or total estradiol to SHBG.Conclusion The method performance of SHBG fits the requirement of lab.There is no correlation of total testosterone or total estradiol to SHBG.