Interlaboratory comparison study of serum total testoserone measurements performed by mass spectrometry methods

Hubert W. Vesper, Shalender Bhasin, Christina Wang, Susan S. Tai, Larry A. Dodge, Ravinder Jit Singh, Judie Nelson, Susan Ohorodnik, Nigel J. Clarke, Wael A. Salameh, C. Richard Parker, Raj Razdan, Elizabeth A. Monsell, Gary L. Myers

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

Background: Though 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. Methods: Twenty 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. Results: The 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. Conclusions: The 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.

Original languageEnglish (US)
Pages (from-to)498-503
Number of pages6
JournalSteroids
Volume74
Issue number6
DOIs
StatePublished - Jun 2009

Fingerprint

Mass spectrometry
Testosterone
Mass Spectrometry
Tandem Mass Spectrometry
Assays
Gas Chromatography-Mass Spectrometry
Serum
High Pressure Liquid Chromatography
Technology
Immunoassay
High performance liquid chromatography
Gas chromatography
Regression Analysis
Regression analysis

Keywords

  • Analytical variability
  • HPLC-MS/MS
  • Method comparison
  • Testosterone

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Endocrinology
  • Molecular Biology
  • Organic Chemistry
  • Pharmacology

Cite this

Interlaboratory comparison study of serum total testoserone measurements performed by mass spectrometry methods. / Vesper, Hubert W.; Bhasin, Shalender; Wang, Christina; Tai, Susan S.; Dodge, Larry A.; Singh, Ravinder Jit; Nelson, Judie; Ohorodnik, Susan; Clarke, Nigel J.; Salameh, Wael A.; Parker, C. Richard; Razdan, Raj; Monsell, Elizabeth A.; Myers, Gary L.

In: Steroids, Vol. 74, No. 6, 06.2009, p. 498-503.

Research output: Contribution to journalArticle

Vesper, HW, Bhasin, S, Wang, C, Tai, SS, Dodge, LA, Singh, RJ, Nelson, J, Ohorodnik, S, Clarke, NJ, Salameh, WA, Parker, CR, Razdan, R, Monsell, EA & Myers, GL 2009, 'Interlaboratory comparison study of serum total testoserone measurements performed by mass spectrometry methods', Steroids, vol. 74, no. 6, pp. 498-503. https://doi.org/10.1016/j.steroids.2009.01.004
Vesper, Hubert W. ; Bhasin, Shalender ; Wang, Christina ; Tai, Susan S. ; Dodge, Larry A. ; Singh, Ravinder Jit ; Nelson, Judie ; Ohorodnik, Susan ; Clarke, Nigel J. ; Salameh, Wael A. ; Parker, C. Richard ; Razdan, Raj ; Monsell, Elizabeth A. ; Myers, Gary L. / Interlaboratory comparison study of serum total testoserone measurements performed by mass spectrometry methods. In: Steroids. 2009 ; Vol. 74, No. 6. pp. 498-503.
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abstract = "Background: Though 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. Methods: Twenty 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. Results: The 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. Conclusions: The 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.",
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T1 - Interlaboratory comparison study of serum total testoserone measurements performed by mass spectrometry methods

AU - Vesper, Hubert W.

AU - Bhasin, Shalender

AU - Wang, Christina

AU - Tai, Susan S.

AU - Dodge, Larry A.

AU - Singh, Ravinder Jit

AU - Nelson, Judie

AU - Ohorodnik, Susan

AU - Clarke, Nigel J.

AU - Salameh, Wael A.

AU - Parker, C. Richard

AU - Razdan, Raj

AU - Monsell, Elizabeth A.

AU - Myers, Gary L.

PY - 2009/6

Y1 - 2009/6

N2 - Background: Though 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. Methods: Twenty 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. Results: The 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. Conclusions: The 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.

AB - Background: Though 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. Methods: Twenty 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. Results: The 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. Conclusions: The 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.

KW - Analytical variability

KW - HPLC-MS/MS

KW - Method comparison

KW - Testosterone

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