Accuracy-based proficiency testing for testosterone measurements with immunoassays and liquid chromatography-mass spectrometry

Cao, Zhi; Botelho, Julianne Cook; Rej, Robert; Vesper, Hubert W.

doi:10.1016/j.cca.2017.03.010

Cited by 30 publications

(17 citation statements)

References 26 publications

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“…Assay standardisation is another area that has to be addressed at the same time 36 . In 2017, Cao et al 37 distributed two male samples and studied assay performance compared with target values using reference measurement procedures operated by the Centers for Disease Control and Prevention (CDC) reference laboratory. Considerable bias existed for all the distributed samples, 13.94 nmol/L (401.7 ng/dL): −24.8% to 8.6%, 17.27 nmol/L (497.7 ng/dL): −22.1% to 6.8%.…”

Section: Discussionmentioning

confidence: 99%

An audit of the measurement and reporting of male testosterone levels in UK clinical biochemistry laboratories

Livingston

Downie

Hackett

et al. 2020

Int. J. Clin. Pract.

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Introduction: A number of guidance documents have been published in recent years for the diagnosis and management of hypogonadism (HG). Laboratory practice has a major role in supporting guidelines with accurate and precise serum total testosterone (TT) methods and standardised pre-and post-analytical protocols. Our study investigated whether laboratory practice currently supports the management guidelines for HG. Methods: An internet-based questionnaire survey of senior laboratory biochemists (UK/Republic of Ireland) was conducted (April-May 2018). Questions reflected sampling, laboratory practice, reference ranges and reporting of results. The results were analysed in conjunction with data obtained from the UK National External Quality Assurance Service (UK NEQAS) on testosterone assay performance. Results: Analyses of 96 laboratory surveys returned the following: 74 laboratories stated that the optimal sampling time was communicated to users; 81 laboratories used immunoassays; 76 laboratories included reference ranges for adult men (31 had dual/multiple age-related intervals). Wide variability in lower/upper limits was evident in the common immunoassays; the majority of reference ranges were from manufacturers (50.0%) or historical (18.8%). Action limits based on TT levels were used by 64 laboratories, but 63 did not report a borderline range as suggested by the guidelines. Protocols for cascading tests based on TT were evident in 58 laboratories, with 50 laboratories offering estimated free testosterone; interpretative comments were provided by 67 laboratories, but no references were made to the management guidelines. Data from UK NEQAS demonstrated considerable variation in testosterone assay performance. Conclusions: Our survey has highlighted inconsistencies that could lead to HG (and other conditions requiring measurement of TT) not being managed appropriately. The results from this survey and from UK NEQAS reinforce the requirement for action to be considered regarding the standardisation of testosterone assays and harmonisation of laboratory practice. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Section: Discussionmentioning

confidence: 99%

An audit of the measurement and reporting of male testosterone levels in UK clinical biochemistry laboratories

Livingston

Downie

Hackett

et al. 2020

Int. J. Clin. Pract.

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“…Furthermore, the results must be interpreted in light of variability among laboratories and techniques of testosterone measurement. 48,49…”

Section: Discussionmentioning

confidence: 99%

Impact of Sequencing of Androgen Suppression and Radiation Therapy on Testosterone Recovery in Localized Prostate Cancer

Roy¹,

Grimes

Eapen

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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Purpose: We performed a secondary analysis of a phase 3 randomized trial to determine the influence of sequencing of radiation therapy and androgen deprivation therapy (ADT) on posttreatment testosterone recovery and implications of testosterone recovery on subsequent relapse. Methods and Materials: Patients with localized prostate cancer with Gleason score 7, clinical stage T1b to T3a, and prostatespecific antigen <30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 months starting 4 months before prostate radiation therapy (NHT arm) or concurrent and adjuvant ADT for 6 months starting simultaneously with radiation therapy (CAHT arm). Full testosterone recovery (FTR) was defined as recovery of testosterone to >10.5 nmol/L in patients with baseline 10.5 nmol/ L or to baseline level in patients with baseline <10.5 nmol/L. Restricted mean survival time (RMST) since ADT initiation to supracastrate testosterone level (>1.7 nmol/L), and to FTR was compared between the arms using a truncation time point of 36 months. Results: The adjusted difference in RMST to supracastrate testosterone between the CAHTand NHTarm was 1.5 months (95% confidence interval [CI], 0.5-2.5; P Z .005). No difference was noted in RMST to FTR between the arms (18.7 vs 18.5 months, adjusted difference: 0.5; 95% CI, e1.4 to 2.4; P Z .61). There was no evidence of heterogeneity of treatment effect (interaction P Z .76) on risk of relapse over subgroups stratified by testosterone recovery to supracastrate level at 15 months after start of ADT. Based on a multistate Markov model, no independent effect of time to FTR on risk of subsequent relapse was observed (adjusted hazard ratio: 1.02; 95% CI, 0.96-1.08).

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“…As a poster of the method's high yield and ease of use, the assay is reportedly routinely done several times a week with 80 patient sample plates, standards and controls, automated sample extraction being completed in around 90 minutes and 5-minute LC-MS/MS sample to sample injection time. There are numerous published studies on LC-MS/MS methods for testosterone quantitation that highlight the multiplex capabilities of the technique and mainstream becoming [20][21][22][23].…”

Section: Testosterone Testingmentioning

confidence: 99%

Current Trends of Liquid Chromatography Tandem Mass Spectroscopy Use in Clinical Gynecology

Petca¹,

Radu²,

Petca³

et al. 2019

Rev. Chim.

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In the present environment of staggering technical innovations and increasing expectations of quality healthcare it is evident that we need to fine tune our diagnostic abilities in order to fulfil patients� demands for more efficient therapies and augmented quality of life. We are looking for current trends in clinical gynecology that make use of Liquid chromatography tandem mass spectroscopy, technology not yet employed in Romanian laboratories for the clinical practice but that is rapidly becoming the worldwide method of choice for accurate characterization of the hormonal milieu essential for the requirements of women healthcare.

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Accuracy-based proficiency testing for testosterone measurements with immunoassays and liquid chromatography-mass spectrometry

Cited by 30 publications

References 26 publications

An audit of the measurement and reporting of male testosterone levels in UK clinical biochemistry laboratories

An audit of the measurement and reporting of male testosterone levels in UK clinical biochemistry laboratories

Impact of Sequencing of Androgen Suppression and Radiation Therapy on Testosterone Recovery in Localized Prostate Cancer

Current Trends of Liquid Chromatography Tandem Mass Spectroscopy Use in Clinical Gynecology

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