Evidence map›Paper›PMID 27197966›Full record

ArticleJournal of endocrinological investigation2016

Highly variable sensitivity of five binding and two bio-assays for TSH-receptor antibodies.

T Diana, C Wüster, M Kanitz, G J Kahaly

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Journal of endocrinological investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

40 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Teprotumumab for Thyroid-Associated Ophthalmopathy.The New England journal of medicine · 2017
    Trial
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  16. Thyrotropin receptor antibodies and Graves' orbitopathy.Journal of endocrinological investigation · 2021
    Review
  17. Article
  18. Review
  19. Article
  20. Management of Graves Thyroidal and Extrathyroidal Disease: An Update.The Journal of clinical endocrinology and metabolism · 2020
    Review
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

4 authors.

T DianaMolecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany.
C WüsterEndocrine Practice, Mainz, Germany.
M KanitzMolecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany.
G J KahalyMolecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany. kahaly@ukmainz.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTSH-receptor (TSHR) antibodies (Ab) can be measured with binding or bio-assays. Sensitivity and specificity of five binding and two bio-assays were compared.

methodsTSHR-blocking (TBAb) and TSHR-stimulating (TSAb) Ab were measured with reporter bio-assays. Blocking activity was defined as percent inhibition of luciferase expression relative to induction with bTSH alone. TSAb was reported as percentage of specimen-to-reference ratio (SRR%). TSHR-binding inhibitory immunoglobulins (TBII) were measured with Kronus, Dynex, Kryptor, Cobas, and Immulite.

resultsSixty patients with Graves' disease (GD), 20 with Hashimoto's thyroiditis (HT), and 20 healthy controls (C) were included. C tested negative in all assays (specificity 100 %) while all 60 hyperthyroid GD patients tested positive in the TSAb bio-assay (sensitivity 100 %). Among these 60 GD patients, 20 had low TSAb positivity (SRR% 140-279), but were TBII positive in only 20 (100 %), 7 (35 %), 9 (45 %), 11 (55 %), and 18 (90 %) using the Kronus, Dynex, Kryptor, Cobas, and Immulite, respectively. In 20 moderate TSAb-positive (SRR% 280-420) patients, TBII tested positive in 20 (100 %), 14 (70 %), 13 (65 %), 16 (80 %), and 19 (95 %), respectively. The high (SRR% > 420) TSAb-positive patients were all TBII positive. All 20 hypothyroid HT patients tested TBAb positive (sensitivity 100 %) in the bio-assay while they tested TBII positive in 20 (100 %), 18 (90 %), 20, 20, and 18, respectively. Results obtained with two luminometers correlated for TSAb positive (r = 0.99, p < 0.001), TBAb positive (r = 0.88, p < 0.001), and C (r = 0.86, p < 0.001). None of the binding assays differentiated between TSAb and TBAb.

conclusionsSensitivity is highly variable between binding and bio-assays for TSHR-Abs.

Indexed as

AdultAgedAutoantibodiesBiomarkersCase-Control StudiesFemaleHumansImmunoassayImmunoglobulins, Thyroid-StimulatingMaleMiddle AgedReceptors, ThyrotropinThyroid DiseasesYoung AdultAutoantibodiesBiomarkersImmunoglobulins, Thyroid-StimulatingReceptors, Thyrotropinthyrotropin-binding inhibitory immunoglobulinBinding assaysBio-assaysSensitivitySpecificityThyroid-blocking antibodiesThyroid-stimulating antibodiesTSH-receptor binding inhibitory immunoglobulins

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Registered trials

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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.