We have standardized our LC/MS/MS method for the quantitation of testosterone levels in serum samples by incorporating the between-run analysis of fifty-eight GC/MS serum reference study patient samples as ongoing independent controls. These samples were tested by an independent laboratory using a GC/MS reference procedure from the database of the Joint Committee for Traceability in Laboratory Medicine. Our LC/MS/MS method includes the use of testosterone-d2 as an internal standard and liquid/liquid sample extraction prior to injection to the LC/MS/MS system. Testosterone standard curve range was 0.0693 - 34.67 nmol/L, with r >0.999. Between-run testing of analytical controls prepared across the curve demonstrated mean %CVs (n=35) within 3.0%. Between-run LC/MS/MS analysis of the fifty-eight GC/MS reference samples showed excellent correlation vs. established GC/MS target levels: Slope = 1.0289, R2 = 0.9988. Our LC/MS/MS method is therefore demonstrated to be an accurate and precise method for the monitoring of serum testosterone levels.

Testosterone LC/MS/MS method standardization using GC/MS reference study serum samples

241st National Meeting (2011)

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