Evidence map›Paper›PMID 30685285›Full record

ArticleContraception2019

A sensitive and robust UPLC-MS/MS method for quantitation of estrogens and progestogens in human serum.

Junmei Zhang, Chenxiao Tang, Patrick J Oberly, Margaret B Minnigh, Sharon L Achilles, Samuel M Poloyac

Abstract readValidation Study
In one paragraph

Article in Contraception, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Junmei ZhangDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Chenxiao TangDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Patrick J OberlyDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Margaret B MinnighDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA.
Sharon L AchillesDepartment of Obstetrics, Gynecology, and Reproductive Sciences and Center for Family Planning Research, School of Medicine, University of Pittsburgh, Pittsburgh, PA; Magee-Womens Research Institute, Pittsburgh, PA.
Samuel M PoloyacDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA. Electronic address: poloyac@pitt.edu.
University of Pittsburgh · US

Funding

Quantification of Immune Cells in Women Using ContraceptionR01AI102835 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ACHILLES, SHARON LYNELLE · 2012 to 2016
$2.7M
API 4000 QTRAPS10RR023461 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI POLOYAC, SAMUEL M · 2007 to 2007
$487k
NCRR NIH HHS S10 RR023461NIAID NIH HHS R01 AI102835
6 · The paper itself

Abstract

objectiveWith the widespread use of sex-steroid hormones in contraceptives and hormone replacement therapy, there is an increasing need for reliable analytical methods. We report the development of a sensitive and robust UPLC-MS/MS method for quantitation of both endogenous and synthetic sex-steroid hormones in human serum. STUDY

designWe developed and validated a UPLC-MS/MS method to quantify progestogens (etonogestrel, levonorgestrel, medroxyprogesterone acetate, norethindrone, progesterone) and estrogens (estradiol and ethinyl estradiol) with good accuracy, high sensitivity, and excellent robustness. We then applied the method to the analysis of sex-steroid hormones in serum from 451 clinical research participants.

resultsEach UPLC-MS/MS analysis was 6.5 min. The lower limits of quantitation (LLOQs) were 25 pg/ml for the progestogens, and 2.5 and 5.0 pg/ml for estradiol and ethinyl estradiol, respectively. When estradiol was analyzed without assessment of progestogens, the LLOQ was reduced to 1 pg/ml. The calibration curves were linear from 25-50,000, 2.5-2000 (1-2000 for estrogens-only analysis) and 5-2000 pg/ml, respectively. Both the accuracy and precision were below±15% not only for routine validation (intraday and interday), but for long-term (>2 years) assay robustness with external controls, thereby, demonstrating the utility of this method for multi-year clinical trial assessments of progestogens and estrogens. We applied the method to quantify sex-steroid levels in 1804 clinical samples.

conclusionsWe successfully developed a UPLC-MS/MS method, and overcame the matrix suppression to allow sensitive quantitation of both synthetic and endogenous sex-steroid hormones in human serum. IMPLICATIONS: We developed a sensitive and robust UPLC-MS/MS method to accurately measure the levels of sex-steroid hormones in serum. The method overcame matrix interference barriers and achieved excellent long-term stability and reproducibility (≥96.9% accuracy; ≤13.0% relative variability measured with external controls over 2 years), demonstrating its utility in clinical sample analysis.

Indexed as

Chromatography, LiquidEstrogensHumansMass SpectrometryProgestinsSensitivity and SpecificityEstrogensProgestinsClinical sample analysisQuantitationReproducibilitySex-steroid hormonesUPLC-MS/MS

Identifiers

PMID30685285
PMCPMC6441366
OpenAlexW2913603753

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.