Harmonisation of serum dihydrotestosterone analysis: establishment of an external quality assurance program
-
Ronda F. Greaves
,
Lisa Jolly
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).
Author contributions:All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership:None declared.
Honorarium: None declared.
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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©2017 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- The central role of external quality assurance in harmonisation and standardisation for laboratory medicine
- Review
- Fecal calprotectin in inflammatory bowel diseases: update and perspectives
- Mini Review
- Factor VIIa-antithrombin complex: a possible new biomarker for activated coagulation
- Opinion Papers
- Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)
- Metabolite profiling can change health-care delivery to obese patients with fatty liver disease: the search for biomarkers
- Genetics and Molecular Diagnostics
- Rapid screening for targeted genetic variants via high-resolution melting curve analysis
- Evaluation of the new cobas® HCV genotyping test based on real-time PCRs of three different HCV genome regions
- General Clinical Chemistry and Laboratory Medicine
- Harmonisation of serum dihydrotestosterone analysis: establishment of an external quality assurance program
- Spanish Preanalytical Quality Monitoring Program (SEQC), an overview of 12 years’ experience
- Peer groups splitting in Croatian EQA scheme: a trade-off between homogeneity and sample size number
- Prevalence of pseudonatremia in a clinical laboratory – role of the water content
- Retrospective validation of a β-trace protein interpretation algorithm for the diagnosis of cerebrospinal fluid leakage
- Economic evaluation of procalcitonin-guided antibiotic therapy in acute respiratory infections: a Chinese hospital system perspective
- Performance evaluation of ImmunoCAP® ISAC 112: a multi-site study
- Clinical autoantibody detection by microarray
- Cardiovascular Diseases
- Kinetics of troponin I in patients with myocardial injury after noncardiac surgery
- Infectious Diseases
- P35 and P22 Toxoplasma gondii antigens abbreviate regions to diagnose acquired toxoplasmosis during pregnancy: toward single-sample assays
- Letters to the Editor
- Deciphering a macro-troponin I complex; a case report
- Interference of laboratory disinfection with trichloro-isocyanuric acid on cardiac troponin I measurement using the Vitros immunoassay system
- Massive interference in free T4 and free T3 assays misleading clinical judgment
- In defense of aldosterone measurement by immunoassay: a broader perspective
- The prevalence of hemolysis – a survey using hemolysis index
- Detection of BRAFV600K mutant tumor-derived DNA in the pleural effusion from a patient with metastatic melanoma
- Evaluation of the accuracy of the Greiner Bio-One FC Mix Glucose tube
- Congress Abstracts
- 4th EFLM-BD European Conference on Preanalytical Phase Amsterdam (NL), 24–25 March 2017
Articles in the same Issue
- Frontmatter
- Editorial
- The central role of external quality assurance in harmonisation and standardisation for laboratory medicine
- Review
- Fecal calprotectin in inflammatory bowel diseases: update and perspectives
- Mini Review
- Factor VIIa-antithrombin complex: a possible new biomarker for activated coagulation
- Opinion Papers
- Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)
- Metabolite profiling can change health-care delivery to obese patients with fatty liver disease: the search for biomarkers
- Genetics and Molecular Diagnostics
- Rapid screening for targeted genetic variants via high-resolution melting curve analysis
- Evaluation of the new cobas® HCV genotyping test based on real-time PCRs of three different HCV genome regions
- General Clinical Chemistry and Laboratory Medicine
- Harmonisation of serum dihydrotestosterone analysis: establishment of an external quality assurance program
- Spanish Preanalytical Quality Monitoring Program (SEQC), an overview of 12 years’ experience
- Peer groups splitting in Croatian EQA scheme: a trade-off between homogeneity and sample size number
- Prevalence of pseudonatremia in a clinical laboratory – role of the water content
- Retrospective validation of a β-trace protein interpretation algorithm for the diagnosis of cerebrospinal fluid leakage
- Economic evaluation of procalcitonin-guided antibiotic therapy in acute respiratory infections: a Chinese hospital system perspective
- Performance evaluation of ImmunoCAP® ISAC 112: a multi-site study
- Clinical autoantibody detection by microarray
- Cardiovascular Diseases
- Kinetics of troponin I in patients with myocardial injury after noncardiac surgery
- Infectious Diseases
- P35 and P22 Toxoplasma gondii antigens abbreviate regions to diagnose acquired toxoplasmosis during pregnancy: toward single-sample assays
- Letters to the Editor
- Deciphering a macro-troponin I complex; a case report
- Interference of laboratory disinfection with trichloro-isocyanuric acid on cardiac troponin I measurement using the Vitros immunoassay system
- Massive interference in free T4 and free T3 assays misleading clinical judgment
- In defense of aldosterone measurement by immunoassay: a broader perspective
- The prevalence of hemolysis – a survey using hemolysis index
- Detection of BRAFV600K mutant tumor-derived DNA in the pleural effusion from a patient with metastatic melanoma
- Evaluation of the accuracy of the Greiner Bio-One FC Mix Glucose tube
- Congress Abstracts
- 4th EFLM-BD European Conference on Preanalytical Phase Amsterdam (NL), 24–25 March 2017
