Evidence map›Paper›PMID 38291818›Full record

ArticleJournal of clinical laboratory analysis2024

Diagnostic accuracy of a novel point-of-care test for simultaneous detection of anti-transglutaminase IgA and anti-deamidated gliadin IgG antibodies.

Giuseppe Parrinello, Mirella Da Re, Francesca Grizzo, Simone Camelliti, Marzia Cozzi, Francesca Marinoni, Danilo Villalta

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical laboratory analysis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.9field-weighted citation impact, top 17% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. 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

7 authors at 2 institutions in 2 countries.

Giuseppe ParrinelloImmunology and Allergy Unit, Santa Maria degli Angeli Hospital, Pordenone, Italy.ORCID https://orcid.org/0000-0002-1510-2718
Mirella Da ReImmunology and Allergy Unit, Santa Maria degli Angeli Hospital, Pordenone, Italy.ORCID https://orcid.org/0000-0002-9852-1431
Francesca GrizzoImmunology and Allergy Unit, Santa Maria degli Angeli Hospital, Pordenone, Italy.
Simone CamellitiPRIMA Lab SA Laboratories, Balerna, Switzerland.ORCID https://orcid.org/0000-0001-5072-2798
Marzia CozziPRIMA Lab SA Laboratories, Balerna, Switzerland.ORCID https://orcid.org/0000-0002-5948-9061
Francesca MarinoniPRIMA Lab SA Laboratories, Balerna, Switzerland.
Danilo VillaltaImmunology and Allergy Unit, Santa Maria degli Angeli Hospital, Pordenone, Italy.ORCID https://orcid.org/0000-0002-8865-4150
Azienda Ospedaliera Santa Maria Degli Angeli · ITApplied Pharma Research (Switzerland) · CH

Funding

PRIMA Lab SA
6 · The paper itself

Abstract

backgroundPoint-of-care tests (POCTs) may have a role in detecting undiagnosed cases of Celiac disease (CD). We assessed the diagnostic accuracy of a novel POCT, compared with the conventional serological methods, for simultaneous anti-transglutaminase (tTG) IgA and anti-deamidated gliadin (DGP) IgG antibody detection. Furthermore, we evaluated the effect of different biological matrices (whole blood and serum) on test performance.

methodsSerum and whole blood from celiac or suspected celiac patients who underwent duodenal biopsy were assayed for the presence of anti-tTG IgA and anti-DGP IgG both with the reference standard methods (Thermo Fisher Scientific, Uppsala, Sweden) and with the POCT (PRIMA Lab SA, Balerna, Switzerland).

results266 sera (101 negative and 165 positive) and 60 whole blood samples (34 positive and 26 negative) were included in the study. POCT for anti-DGP IgG showed a sensitivity of 84.3% and a specificity of 90.1%, with positive (PPV) and negative predictive values (NPV) of 91.07% and 82.73%. POCT for anti-tTG IgA showed a sensitivity of 98.31% and a specificity of 98.02%, with a PPV and NPV of 98.31% and 98.02%. Test accuracies were 86.94% and 98.17%, respectively. The agreement of the results between the two different matrices showed a strong correlation rate: 95% for anti-DGP IgG and 100% for anti-tTG IgA.

conclusionThe anti-tTG IgA/anti-DGP IgG-based POCT showed good diagnostic accuracy with comparable sensitivities and specificities to reference standard methods in detecting CD in symptomatic patients and could be considered as a mass screening test before referring to conventional serology.

Indexed as

Celiac DiseaseTransglutaminasesAutoantibodiesGliadinHumansImmunoglobulin AImmunoglobulin GPoint-of-Care TestingSensitivity and SpecificityAutoantibodiesGliadinImmunoglobulin AImmunoglobulin GTransglutaminasesanti-deamidated gliadin antibodiesanti-transglutaminase antibodiescase-finding testceliac diseaseearly diagnosislateral-flow immunochromatography assayspoint-of-care testingscreening test

Identifiers

PMID38291818
PMCPMC10873685
OpenAlexW4391400556

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.