Dataset Information

Estimating testosterone concentrations in adolescent girls: Comparison of two direct immunoassays to liquid chromatography-tandem mass spectrometry.

ABSTRACT:

Context

The appropriate role of direct total testosterone (T) immunoassays in reproductive research is controversial.

Objective

To assess the concordance between two direct immunoassays and a liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay for total T in adolescent girls with measured concentrations < 50 ng/dl.

Design

Cross-sectional analysis.

Setting

Academic medical center.

Participants

Adolescent girls (age 8.4-18.1 years) participating in clinical research protocols.

Intervention

Paired blood samples were obtained for total T by LC-MS/MS (n = 66; Mayo Clinic Laboratory) and by direct immunoassay (Center for Research in Reproduction)-either radioimmunoassay (RIA; n = 31) or chemiluminescence immunoassay (CLIA; n = 35). At the time of assay, laboratories were unaware that results would be compared.

Main outcome measure

Measurement agreement between immunoassay and LC-MS/MS.

Results

Measured T concentrations (LC-MS/MS) were <7 to 44 ng/dl. The average difference between RIA and LC-MS/MS was 0.84 [-0.89, 2.56] ng/dl (mean [95% confidence interval]). RIA correlated very strongly with LC-MS/MS (r = 0.899; p < 0.0001); and both Deming regression and Bland-Altman analysis suggested no bias. The average difference between chemiluminescence and LC-MS/MS was 1.39 [-0.83, 3.60] ng/dl. CLIA correlated strongly with LC-MS/MS (r = 0.806; p < 0.0001). While Bland-Altman analysis suggested no systematic bias, Deming regression analysis suggested that, as measured values increased, values obtained by CLIA tended to be progressively, albeit only modestly, higher than those obtained by LC-MS/MS.

Conclusions

These data support the use of rigorously-performed and carefully-validated direct T immunoassays in high-quality endocrine research in peripubertal adolescent girls.

SUBMITTER: McCartney CR

PROVIDER: S-EPMC7017602 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Estimating testosterone concentrations in adolescent girls: Comparison of two direct immunoassays to liquid chromatography-tandem mass spectrometry.

McCartney Christopher R CR Burt Solorzano Christine M CM Patrie James T JT Marshall John C JC Haisenleder Daniel J DJ

Steroids 20180912

<h4>Context</h4>The appropriate role of direct total testosterone (T) immunoassays in reproductive research is controversial.<h4>Objective</h4>To assess the concordance between two direct immunoassays and a liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay for total T in adolescent girls with measured concentrations < 50 ng/dl.<h4>Design</h4>Cross-sectional analysis.<h4>Setting</h4>Academic medical center.<h4>Participants</h4>Adolescent girls (age 8.4-18.1 years) participating in c ...[more]

PMID: 30217784

Similar Datasets

Project description:Testosterone is a critical hormone involved in regulating various physiological processes in both men and women. Accurate testosterone measurement is essential for diagnosing endocrine disorders such as hypogonadism and polycystic ovary syndrome and for routine testing. Traditionally, testosterone levels are measured using serum or plasma samples, which present challenges in sample collection, storage, and transport, particularly in resource-limited settings. Dried blood spot (DBS) sampling has emerged as an effective alternative for hormone analysis, offering significant advantages in terms of sample stability, ease of collection, and simplified logistics. This study aimed to validate a DBS-based testosterone assay using liquid chromatography-tandem mass spectrometry (LC-MS/MS) to ensure accuracy and precision comparable to conventional serum-based methods. Drops of whole blood samples were collected from adult volunteers using a single-use safety lancet for finger pricks, with blood applied onto DBS cards (PerkinElmer 226 Spot Saver RUO card) for further analysis. The testosterone was extracted from DBS using a liquid-liquid method and analyzed with LC-MS/MS. The assay demonstrated excellent linearity across a wide concentration range (0.1-100 ng/mL) with a correlation coefficient (r2) of 0.999 and achieved a lower limit of detection of 0.058 ng/mL and a lower limit of quantification of 0.086 ng/mL. The method showed high precision, with intra- and inter-day coefficients of variation below 10%, and satisfactory recovery rates. Hematocrit correction and matrix effect evaluations confirmed the robustness of the assay for clinical and research applications. Additionally, the assay displayed a strong clinical correlation between testosterone levels in DBS and venous serum samples, supporting its reliability for testosterone monitoring. This validation study supports that the DBS-based LC-MS/MS testosterone assay is a reliable tool for testosterone quantification for routine testing.

Dataset Information

Estimating testosterone concentrations in adolescent girls: Comparison of two direct immunoassays to liquid chromatography-tandem mass spectrometry.

Context

Objective

Design

Setting

Participants

Intervention

Main outcome measure

Results

Conclusions

Publications

Estimating testosterone concentrations in adolescent girls: Comparison of two direct immunoassays to liquid chromatography-tandem mass spectrometry.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets