Subgroup analysis for assay type was statistically significant for spontaneous POI only .
Sensitivity analyses of high- quality studies did not change the results , and result ed in a substantial decrease in heterogeneity in spontaneous POI studies .
The current meta- analysis demonstrates that total testosterone concentrations are decreased in women with spontaneous POI or iatrogenic menopause .
BACKGROUND Increasing age and post-menopausal status are associated with decreasing and rogen concentrations in females .
Women with premature loss of ovarian function , such as primary ovarian insufficiency ( POI ) or iatrogenic menopause may be at increased risk for diminished testosterone levels at a relatively young age .
Differentiation between a hypo and rogenic or normo and rogenic state in women with premature loss of ovarian function is problematic due to trueness and precision problems using various testosterone assays .
The current meta- analysis was conducted to evaluate current literature reporting serum total testosterone concentrations under these conditions , including stratification for various testosterone assays .
Measurement of total serum testosterone levels using commercially available kits: high degree of between-kit variability.
OBJECTIVE The measurement of total serum testosterone has an established clinical role in the management of male hypogonadism and female and rogen excess disorders . We studied the between-kit variability and precision of six different commercially available testosterone assays and compared them with an established in-house method . DESIGN Laboratory observational prospect i ve study . SETTING Tertiary university medical center clinical laboratory . PATIENT(S ) Three groups of sample s each of men ( n = 36 ) and women ( n = 15 ) who had high , normal , or low levels of sex hormone-binding globulin ( SHBG ) , respectively , were studied . INTERVENTION(S ) Individual and pooled ( male and female ) serum sample s were analyzed for total testosterone concentration using six different commercially available assays and one in-house method . MAIN OUTCOME MEASURE(S ) The between-kit variability and the effect of the mean ( + /- SD ) SHBG level were determined , the results obtained with the use of the kits and the in-house method were compared , and the intraassay variability ( i.e. , precision ) was evaluated . RESULT ( S ) Male sample s demonstrated a 26.3%-40.8 % variance in the results obtained with different kits , which was greatest for sample s with the lowest SHBG levels . For female sample s , between-kit variability ranged from 57%-115 % ( average , 77 % ) . The percent deviation of the results obtained with the use of commercial methods from those obtained with the use of our in-house assay was greater for men ( mean variance , 194 % ) than for women ( mean variance , 67 % ) . The female pool intraassay coefficient of variation was 3.8 % with the use of the in-house method and ranged from 8.9%-21.2 % with the use of the commercial kits . The male pool intraassay coefficient of variation was 3.1 % with the use of the in-house method and ranged from 3.3%-5.5 % with the use of the commercial kits . CONCLUSION ( S ) Most commercially available kits for measuring the total serum testosterone level demonstrated significant between-kit variability , which was greatest for female sample s. Further , sample s with the lowest SHBG levels had the highest between-kit variances . These data strongly suggest that the measurement of total serum testosterone using commercial kits may have limited utility , particularly for the detection of hyper and rogenemia
Subgroup analysis for assay type was statistically significant for spontaneous POI only .
Sensitivity analyses of high- quality studies did not change the results , and result ed in a substantial decrease in heterogeneity in spontaneous POI studies .
The current meta- analysis demonstrates that total testosterone concentrations are decreased in women with spontaneous POI or iatrogenic menopause .
BACKGROUND Increasing age and post-menopausal status are associated with decreasing and rogen concentrations in females .
Women with premature loss of ovarian function , such as primary ovarian insufficiency ( POI ) or iatrogenic menopause may be at increased risk for diminished testosterone levels at a relatively young age .
Differentiation between a hypo and rogenic or normo and rogenic state in women with premature loss of ovarian function is problematic due to trueness and precision problems using various testosterone assays .
The current meta- analysis was conducted to evaluate current literature reporting serum total testosterone concentrations under these conditions , including stratification for various testosterone assays .