ArticleClinical biochemistry2024
Accuracy-based proficiency testing for estradiol measurements.
Article in Clinical biochemistry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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.
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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.
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Who cites it
3 citing papers in PubMed, 6 citations in OpenAlex.
- Pharmacokinetic analysis of 25 mg estradiol subcutaneous bioabsorbable implant in postmenopausal women (CLARA STUDY).Menopause (New York, N.Y.) · 2026Article
- Call for Standardization of C-Peptide Measurement.Journal of diabetes science and technology · 2025Review
- Breast cancer in a transgender man.CA: a cancer journal for cliniciansArticle
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
Abstract
objectivesAccuracy of estradiol measurements is important but conventional proficiency testing (PT) cannot assess accuracy when possibly non-commutable samples are used and method peer-group means are the targets. Accuracy-based assessment of estradiol measurements is needed. DESIGN AND
methodsFive serum samples were prepared from single donors, frozen, and distributed overnight to 76 New York State Department of Health (NYSDOH)-certified laboratories. Participants analyzed samples for estradiol. The biases of group means were assessed against the Centers for Disease Control and Prevention (CDC)-defined targets, evaluated using the Hormone Standardization Program (HoSt) E2 performance criterion of ±12.5 %. Each laboratory's performance was evaluated using total allowable error (acceptance limits) of target ±25 % or ±15 pg/mL (55 pmol/L) (whichever was greater, NYSDOH), target ±30 % (Clinical Laboratory Improvement Amendments [CLIA]), and target ±26 % (minimal limit based on biological variation [BV]).
resultsThe biases (range) were 34 % (-17 % to 175 %), 40 % (-33 % to 386 %), 16 % (-45 % to 193 %), 5 % (-27 % to 117 %), and -4% (-31 % to 21 %), for samples at estradiol of 24.1, 28.4, 61.7, 94.1, and 127 pg/mL, or 89, 104, 227, 345, and 466 pmol/L, respectively. Large positive method/analytical systematic biases were revealed for 9 commonly used method/analytical systems in the United States at low estradiol concentrations. Of the 9 analytical systems, 0, 0, 3, 7 and 6 met the HoSt criterion for the samples with estradiol at the five respective concentrations. PT evaluation showed that 59 %, 69 % and 87 % of laboratories would receive a PT event passing (satisfactory) score when the CDC-defined target and a criterion of NYSDOH, CLIA or BV was used, respectively. However, >95 % laboratories would obtain PT passing score if method peer-group means were used as targets regardless of the criterion used.
conclusionsImprovement in accuracy of estradiol measurements is needed, particularly at low estradiol concentrations. Accuracy-based PT provides unambiguous information about the accuracy of methods/analytical systems.
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