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Interlaboratory comparison study of serum total testoserone measurements performed by mass spectrometry methods |
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| Authors: | Hubert W Vesper Shalender Bhasin Susan S Tai Ravinder J Singh Susan Ohorodnik Wael A Salameh Raj Razdan Gary L Myers |
| Institution: | a Centers for Disease Control and Prevention, 4770 Buford Highway, NE F25, Atlanta, GA 30341-3724, United States b Boston University, School of Medicine, 670 Albany Street, Boston, MA 02118, United States c Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, UCLA School of Medicine, 1000 W. Carson Street, Torrance, CA 90509, United States d National Institute of Standards and Technology, Chemical Science and Technology Laboratory, Analytical Chemistry Division, Gaithersburg, MD 20899, United States e Mayo Foundation, 730 Hilton Building, Rochester, MN 55905, United States f Newborn Screening/Biochemical Genetics Labs, Children's & Women's Health Centre of BC, 4480 Oak Street, Vancouver, BC V6H-3V4, United States g Taylor Technology, Inc., 301D College Road East, Princeton, NJ 08540, United States h QuestDiagnostics Nichols Institute, 33608 Ortega Highway, San Juan Capistrano, CA 92675, United States i University of Alabama at Birmingham, Department of Obstetrics and Gynecology, 618 South 20th Street, Birmingham, AL 35294, United States |
| Abstract: | BackgroundThough mass spectrometry (MS) assays are increasingly used for routine clinical measurements of serum total testosterone (TT), information about the variability of results is limited. This study assessed the variability of TT measurement results from routine MS assays.MethodsTwenty serum samples (12 females, 8 males) were analyzed on 2 days by seven high performance liquid chromatography (HPLC), and one gas chromatography (GC)-tandem mass spectrometry (HPLC-MS/MS, GC-MS/MS) assays. Two samples (male and female) were provided in five replicates to assess the within-run variability. Results were compared against those obtained at National Institute of Standards and Technology (NIST). The within- and between-laboratory variability was assessed for each sample. Comparisons to the NIST results were performed using bias plot and Deming regression analysis.ResultsThe overall coefficient of variation of the results obtained with MS assays was <15%CV at >1.53 nmol/L and <34%CV at 0.3 nmol/L. The between-assay variability was the major contributor to the overall variability. The assay precision was the highest (<3%CV) with assays using liquid-liquid extraction for sample preparation or GC-MS/MS. The mean percent difference to the reference assay was 11%. The slopes of Deming regression analysis of the MS assays were between 0.903 and 1.138 (correlation coefficient: >0.996). TT concentrations for one assay were above the measurement range.ConclusionsThe variability of TT measurement results among MS assays is substantially smaller than that reported for immunoassays. The type of sample preparation may affect assay precision. Standardizing assays can further reduce the variability of measurement results. |
| Keywords: | Testosterone HPLC-MS/MS Method comparison Analytical variability |
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