# Total Testosterone Measured by Liquid Chromatograph‐Tandem Mass Spectrometry Refines Diagnosis of Biochemical Hyperandrogenism and Better Identifies Subgroup at Genuine Risk of Adverse Fertility Outcomes in Women With Polycystic Ovary Syndrome

## TL;DR

Using a more accurate testosterone test helps better diagnose hormone issues and identify fertility risks in women with PCOS.

## Contribution

LC–MS/MS provides more accurate testosterone measurements than ECLIA, improving diagnosis and risk identification in PCOS.

## Key findings

- ECLIA overestimates testosterone levels compared to LC–MS/MS.
- Only LC–MS/MS identifies women with PCOS at higher risk of adverse fertility outcomes.
- Biochemical hyperandrogenism defined by LC–MS/MS is more clinically relevant.

## Abstract

To compare total testosterone (TT) measured by liquid chromatograph‐tandem mass spectrometry (LC–MS/MS) with electro‐chemiluminescent immunoassay (ECLIA) in the diagnosis and management of infertile women with polycystic ovary syndrome (PCOS).

Baseline TT was measured by LC–MS/MS and ECLIA in 906 infertile women with PCOS. The associations of TT from both methods with clinical phenotypes and fertility outcomes were estimated; relative risk (RR) and 95% confidence intervals (CIs) were computed. Subgroup analysis was conducted according to the TT levels.

The average TT levels measured by ECLIA were higher than those measured by LC–MS/MS (mean percentage difference 23.8%, 95% limits of agreement −44.2% to 91.9%). When biochemical hyperandrogenism (HA) defined as TT ≥ 1.7 nmol/L by LC–MS/MS method, a higher proportion of patients were identified having biochemical HA using ECLIA (44.0% vs. 24.0%, p < 0.001) than LC–MS/MS. Only those with TT levels ≥ 1.7 nmol/L measured by LC–MS/MS had an increased risk of adverse fertility outcomes compared to patients with normal TT levels, including ovulation, preterm labor, and neonatal intensive care unit.

Our findings indicated that LC–MS/MS refined the diagnosis of biochemical hyperandrogenism and better identified the subgroup at genuine risk of adverse fertility outcomes in infertile women with PCOS.

The NIH Clinical Trial Registry number: NCT01573858 and Chinese Clinical Trial. Registry number: ChiCTR‐TRC‐12002081