Evidence map›Paper›PMID 30241771›Full record

ArticleReproductive biomedicine online2018

Towards international standardization of immunoassays for Müllerian inhibiting substance/anti-Müllerian hormone.

Jackie Mc Ferguson, David Pépin, Chinwe Duru, Paul Matejtschuk, Patricia K Donahoe, Chris J Burns

Open access · bronzeAbstract read
In one paragraph

Article in Reproductive biomedicine online, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
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  18. Establishment of a WHO Reference Reagent for anti-Mullerian hormone.Reproductive biology and endocrinology : RB&E · 2020
    Article
  19. The role of anti-Müllerian hormone (AMH) in ovarian disease and infertility.Journal of assisted reproduction and genetics · 2020
    Review
  20. Article
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 2 institutions in 2 countries.

Jackie Mc FergusonBiotherapeutics Division, NIBSC, South Mimms, Potters Bar Hertfordshire, UK. Electronic address: jackie.ferguson@nibsc.org.
David PépinPediatric Surgical Research Laboratories, Massachusetts General Hospital, CPZN 6206, MA, USA.
Chinwe DuruTechnology, Development and Infrastructure Division, NIBSC, South Mimms, Potters Bar Hertfordshire, UK.
Paul MatejtschukTechnology, Development and Infrastructure Division, NIBSC, South Mimms, Potters Bar Hertfordshire, UK.
Patricia K DonahoePediatric Surgical Research Laboratories, Massachusetts General Hospital, CPZN 6206, MA, USA.
Chris J BurnsBiotherapeutics Division, NIBSC, South Mimms, Potters Bar Hertfordshire, UK.
National Institute for Biological Standards and Control · GBMassachusetts General Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

research questionIs formulated and lyophilized, recombinant human Müllerian inhibiting substance, also known as anti-Müllerian hormone (AMH), suitable for the preparation of a WHO international standard to calibrate AMH immunoassays?

designThe AMH content of a trial preparation, coded SS-581, was determined by five laboratories using seven immunoassay methods. Participants were requested to report the content of the preparation in terms of their method calibrators through the measurement of a minimum of five concentrations in the linear part of the dose-response curve. Participants were also asked to measure, concomitantly, a panel of six serum samples containing AMH at concentrations of 0.1-13.0 ng/ml.

resultsAcross all assays, including two automated assays in development, the geometric mean content was 361.76 ng/ampoule with a geometric coefficient of variation (GCV%) of 39.95%. When measured by immunoassays that were commercially available at the time of the study, the mean content was 423.08 ng/ampoule, with a GCV% of 26.67%. The inter-method geometric means of five serum samples with an AMH concentration >0.3 ng/ml and measured concomitantly with dilutions of SS-581 varied with a range of GCV% of 14.90-22.35%, which may reflect the use of serum sample value transfer to calibrate current immunoassays, some of which use non-human AMH calibrators. The AMH in trial preparation SS-581 was shown to be biologically active in the Müllerian duct regression assay.

conclusionsA reference material prepared using human recombinant AMH is a promising candidate for the preparation of an international standard for AMH for immunoassays calibrated to recombinant human AMH.

Indexed as

Anti-Mullerian HormoneCalibrationFemaleHumansImmunoassayAnti-Mullerian HormoneAnti-Müllerian hormoneImmunoassayInternational standardMüllerian inhibiting substanceWHOWorld Health Organization

Identifiers

PMID30241771
PMCPMC6302068
OpenAlexW2890964161

What OpenQuestion holds

Textmetadata
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.