title: Measurement of total serum testosterone levels using commercially available kits: high degree of between-kit variability.
abstract: OBJECTIVE
  The measurement of total serum testosterone has an established clinical role in the management of male hypogonadism and female androgen 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.
  
  
  METHODS
  Laboratory observational prospective study.
  
  
  METHODS
  Tertiary university medical center clinical laboratory.
  
  
  METHODS
  Three groups of samples 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.
  
  
  METHODS
  Individual and pooled (male and female) serum samples were analyzed for total testosterone concentration using six different commercially available assays and one in-house method.
  
  
  METHODS
  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.
  
  
  RESULTS
  Male samples demonstrated a 26.3%-40.8% variance in the results obtained with different kits, which was greatest for samples with the lowest SHBG levels. For female samples, 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.
  
  
  CONCLUSIONS
  Most commercially available kits for measuring the total serum testosterone level demonstrated significant between-kit variability, which was greatest for female samples. Further, samples 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 hyperandrogenemia.
authors.affiliation: Department of Obstetrics and Gynecology, University of Alabama at Birmingham 35233-7333, USA.
authors.forename: L R
authors.initials: LR
authors.lastname: Boots
authors.forename: S
authors.initials: S
authors.lastname: Potter
authors.forename: D
authors.initials: D
authors.lastname: Potter
authors.forename: R
authors.initials: R
authors.lastname: Azziz
mesh_terms: D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012738:Sex Hormone-Binding Globulin / Q000032:analysis; D013739:Testosterone / Q000097:blood*
chemical_list: D011933:Reagent Kits, Diagnostic; D012738:Sex Hormone-Binding Globulin; D013739:Testosterone