Accessible Requires Authentication Published by De Gruyter October 4, 2016

Harmonisation of serum dihydrotestosterone analysis: establishment of an external quality assurance program

Ronda F. Greaves, Lisa Jolly, Michaela F. Hartmann, Chung Shun Ho, Richard K.T. Kam, John Joseph, Conchita Boyder and Stefan A. Wudy

Abstract

Background:

Serum dihydrotestosterone (DHT) is an important analyte for the clinical assessment of disorders of sex development. It is also reportedly a difficult analyte to measure. Currently, there are significant gaps in the standardisation of this analyte, including no external quality assurance (EQA) program available worldwide to allow for peer review performance of DHT. We therefore proposed to establish a pilot EQA program for serum DHT.

Methods:

DHT was assessed in the 2015 Royal College of Pathologists of Australasia Quality Assurance Programs’ Endocrine program material. The material’s target (i.e. “true”) values were established using a measurement procedure based on isotope dilution gas chromatography (GC) tandem mass spectrometry (MS/MS). DHT calibrator values were based on weighed values of pure DHT material (>97.5% purity) from Sigma. The allowable limits of performance (ALP) were established as ±0.1 up to 0.5 nmol/L and ±15% for targets >0.5 nmol/L.

Results:

Target values for the six levels of RCPAQAP material for DHT ranged from 0.02 to 0.43 nmol/L (0.01–0.12 ng/mL). The material demonstrated linearity across the six levels. There were seven participating laboratories for this pilot study. Results of the liquid chromatography (LC) MS/MS methods were within the ALP; whereas the results from the immunoassay methods were consistently higher than the target values and outside the ALP.

Conclusions:

This report provides the first peer comparison of serum DHT measured by mass spectrometry (MS) and immunoassay laboratories. Establishment of this program provides one of the pillars to achieve method harmonisation. This supports accurate clinical decisions where DHT measurement is required.

Acknowledgments

We thank Mrs. Emily Glen (RMIT University Graphic Artist) for her patience and attention to detail in relation to the production of Figure 2. This figure was produced as part of a RMIT University learning and teaching project led by Dr Greaves. We wish to acknowledge the following organisations for their collaborative support for this work: Royal College of Pathologist of Australasia Quality Assurance Programs (RCPAQAP), Australasian Association of Clinical Biochemists (AACB), the Asia Pacific Federation of Clinical Biochemistry and Laboratory Medicine (APFCB) MS Harmonisation Working Group and COST Action BM 1303 “DSDnet” (http://www.dsdnet.eu/) working group 3 “Harmonisation of Laboratory Assessment”. Stefan Wudy is grateful for support (Grant WU 148/6) by the German Research Council (Deutsche Forschungsgemeinschaft, DFG).

  1. Author contributions:All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership:None declared.

  4. Honorarium: None declared.

  5. Competing interests:The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2016-5-5
Accepted: 2016-7-18
Published Online: 2016-10-4
Published in Print: 2017-3-1

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