Evidence map›Paper›PMID 41387261›Full record

SynthesisJournal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology2026

Diagnostic Agreement in Subepidermal Blistering Diseases: Is ELISA Test Reliable as Direct Immunofluorescence? A Systematic Review, Meta-Analysis, and Trial Sequential Analysis.

Romeo Patini, Gioele Gioco, Michele Davide Mignogna, Stefania Leuci, Francesco Scilla, Davide Gentile, Cosimo Rupe, Enrico Russo, Anna Schiavelli, Carlo Lajolo

Abstract readSystematic ReviewMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Romeo PatiniHead and Neck Department, Fondazione Policlinico Universitario A. Gemelli-IRCCS, School of Dentistry, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID https://orcid.org/0000-0001-7358-8763
Gioele GiocoHead and Neck Department, Fondazione Policlinico Universitario A. Gemelli-IRCCS, School of Dentistry, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID https://orcid.org/0000-0002-8637-2029
Michele Davide MignognaDepartment of Neuroscience, Reproductive and Odontostomatological Sciences, Oral Medicine Unit, University of Naples Federico II, Naples, Italy.
Stefania LeuciDepartment of Neuroscience, Reproductive and Odontostomatological Sciences, Oral Medicine Unit, University of Naples Federico II, Naples, Italy.
Francesco ScillaHead and Neck Department, Fondazione Policlinico Universitario A. Gemelli-IRCCS, School of Dentistry, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID https://orcid.org/0009-0000-6418-1320
Davide GentileDepartment of Chemical Science and Technologies, PhD in Materials for Sustainable Development - Dentistry, University of Rome Tor Vergata, Rome, Italy.ORCID https://orcid.org/0009-0000-1862-4821
Cosimo RupeHead and Neck Department, Fondazione Policlinico Universitario A. Gemelli-IRCCS, School of Dentistry, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID https://orcid.org/0000-0001-9928-4100
Enrico RussoHead and Neck Department, Fondazione Policlinico Universitario A. Gemelli-IRCCS, School of Dentistry, Università Cattolica del Sacro Cuore, Rome, Italy.
Anna SchiavelliHead and Neck Department, Fondazione Policlinico Universitario A. Gemelli-IRCCS, School of Dentistry, Università Cattolica del Sacro Cuore, Rome, Italy.
Carlo LajoloHead and Neck Department, Fondazione Policlinico Universitario A. Gemelli-IRCCS, School of Dentistry, Università Cattolica del Sacro Cuore, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesDirect immunofluorescence (DIF) is the gold standard for diagnosing subepidermal blistering diseases (SBDs). However, DIF requires specialized expertise; therefore, alternative immunological methods such as enzyme-linked immunosorbent assays (ELISA) are worth exploring. The aim of this review was to evaluate the diagnostic agreement between DIF and ELISA for the diagnosis of SBD. MATERIALS AND

methodsA systematic literature review of international journals and electronic databases (MEDLINE via OVID, Scopus, and Web of Science) was conducted between their inception and December 2023. The risk of bias and overall quality of evidence were assessed using the Newcastle-Ottawa Scale and the GRADE system.

resultsOf the 1691 articles identified, 38 were included in the qualitative synthesis and 37 in the quantitative analysis. Three meta-analyses were developed and revealed the superiority of DIF over ELISA, with the following risk differences: BP180, 0.26 (95% CI: 0.19-0.33, p < 0.00001, I

conclusionsDIF remains the gold standard for the diagnosis of autoimmune SBDs. ELISA can serve as a complementary diagnostic tool, especially as a follow-up instrument for patients with SBD, owing to its low invasiveness.

Indexed as

BlisterSkin Diseases, VesiculobullousEnzyme-Linked Immunosorbent AssayFluorescent Antibody Technique, DirectHumansReproducibility of Results

Identifiers

PMID41387261
PMCPMC13065897

What OpenQuestion holds

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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.