Evidence map›Paper›PMID 31339913›Full record

ArticlePloS one2019

Evaluation of the sensitivity and specificity of a novel line immunoassay for the detection of criteria and non-criteria antiphospholipid antibodies in comparison to established ELISAs.

Markus A Thaler, Andreas Bietenbeck, Udo Steigerwald, Thomas Büttner, Peter Schierack, Edelgard Lindhoff-Last, Dirk Roggenbuck, Peter B Luppa

Open access · goldAbstract readComparative StudyEvaluation Study
In one paragraph

Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

6 citing papers in PubMed, 9 citations in OpenAlex.

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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

8 authors at 5 institutions in 1 country.

Markus A ThalerInstitut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der Technischen Universität München, München, Germany.ORCID 0000-0002-5010-0718
Andreas BietenbeckInstitut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der Technischen Universität München, München, Germany.
Udo SteigerwaldZentrallabor, Zentrum Innere Medizin-A4, Universitätsklinikum Würzburg, Würzburg, Germany.
Thomas BüttnerMedipan / GA Generic Assays GmbH, Dahlewitz, Germany.
Peter SchierackInstitut für Biotechnologie, Fakultät Umwelt und Naturwissenschaften, Brandenburgische Technische Universität Cottbus-Senftenberg, Senftenberg, Germany.
Edelgard Lindhoff-LastCoagulation Research Center CCB (Cardioangiologisches Centrum Bethanien), Frankfurt am Main, Germany.
Dirk RoggenbuckMedipan / GA Generic Assays GmbH, Dahlewitz, Germany.
Peter B LuppaInstitut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der Technischen Universität München, München, Germany.
TUM Klinikum · DEMedipan (Germany) · DEBrandenburg University of Technology Cottbus-Senftenberg · DECardiovascular Center Bethanien · DEUniversitätsklinikum Würzburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPersistent antiphospholipid antibodies (aPL) constitute the serological hallmark of the antiphospholipid syndrome (APS). Recently, various new assay technologies for the detection of aPL better suited to multiplex reaction environments than ELISAs emerged. We evaluated the diagnostic performance of such a novel line immunoassay (LIA) for the simultaneous detection of 10 different aPL.

methodsFifty-three APS patients and 34 healthy controls were investigated for criteria (antibodies against cardiolipin [aCL], β2-glycoprotein I [aβ2-GPI]) and non-criteria aPL (antibodies against phosphatidic acid [aPA], phosphatidyl-choline [aPC], -ethanolamine [aPE], -glycerol [aPG], -inositol [aPI], -serine [aPS], annexin V [aAnnV], prothrombin [aPT]) IgG and IgM by LIA. Criteria aPL were additionally determined with the established Alegria (ALE), AcuStar (ACU), UniCap (UNI), and AESKULISA (AES) systems and non-criteria aPL with the AES system. Diagnostic performance was evaluated with a gold standard for criteria aPL derived from the results of the four established assays via latent class analysis and with the clinical diagnosis as gold standard for non-criteria aPL.

resultsAssay performance of the LIA for criteria aPL was comparable to that of ALE, ACU, UNI, and AES. For non-criteria aPL, sensitivities of the LIA for aPA-, aPI-, aPS-IgG and aPA-IgM were significantly higher and for aPC-, aPE-, aAnnV-IgG and aPC- and aPE-IgM significantly lower than AES. Specificities did not differ significantly.

conclusionsThe LIA constitutes a valuable diagnostic tool for aPL profiling. It offers increased sensitivity for the detection of aPL against anionic phospholipids. In contrast, ELISAs exhibit strengths for the sensitive detection of aPL against neutral phospholipids.

Indexed as

AdultAntibodies, AntiphospholipidAntiphospholipid SyndromeFemaleHumansImmunoassayMaleMiddle AgedPhospholipidsSensitivity and SpecificitySerologic TestsAntibodies, AntiphospholipidPhospholipids

Identifiers

PMID31339913
PMCPMC6655644
OpenAlexW2963191165

What OpenQuestion holds

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LicenceCC BY
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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.