Falk · Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 2008 · Assay validation and cross-sectional study · n=45

A liquid chromatography-mass spectrometry method for the simultaneous measurement of 15 urinary estrogens and estrogen metabolites: assay reproducibility and interindividual variability.

Cited 67 times in the scientific literature.

Level 4 - case-series / case-control

Cross-sectional analytical validation study using human urine samples

PubMed 19064556 · doi:10.1158/1055-9965.EPI-08-0355 · record verified 2026-08-30

What was done

Researchers developed an HPLC-tandem mass spectrometry (HPLC-MS/MS) assay to simultaneously measure 15 urinary estrogens and estrogen metabolites across parent, catechol, 16alpha-pathway, and methoxy estrogen classes. Assay reproducibility was tested using blinded, randomized duplicate aliquots of overnight urine from 20 individuals (5 follicular-phase premenopausal women, 5 luteal-phase premenopausal women, 5 postmenopausal women, and 5 men) run across four batches. An additional 25 participants (total n = 45) were evaluated to assess interindividual variability and metabolite profiles across groups.

What was found

Assay coefficients of variation (CV) were ≤10% for all 15 metabolites, and intraclass correlation coefficients (ICCs) within menstrual/sex groups were generally ≥98%. Five metabolites (estriol, 2-hydroxyestrone, estrone, estradiol, and 16-ketoestradiol) comprised 60% to 75% of total urinary metabolites across all groups. Within each group, absolute concentrations showed marked interindividual variability, spanning a 10- to 100-fold range for nearly all metabolites.

Why it matters

This assay provides a highly reproducible, multi-pathway LC-MS/MS panel to quantify endogenous estrogen exposures and metabolic profiles for large-scale breast cancer and endocrine epidemiological research.

Limits

The total sample size was small (n = 45; n = 20 for the core reproducibility assessment). The study evaluated single overnight urine samples and did not measure blood or breast tissue levels.

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