Evidence map›Paper›PMID 41121724›Full record

ArticleRespirology (Carlton, Vic.)2026

Rapid Serological Detection of Anti-GM-CSF Autoantibodies in Autoimmune Pulmonary Alveolar Proteinosis Using a Novel Immunochromatographic Test.

Chika Narita, Kenjiro Shima, Jun-Ichiro Sekiguchi, Yasuyuki Ozeki, Makoto Akiwa, Shohei Koike, Sachiko Yuki, Keiichi Akasaka, Toshiaki Kikuchi, Nobutaka Kitamura and 1 more

Abstract read
In one paragraph

Article in Respirology (Carlton, Vic.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

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

  1. The burden of autoimmune pulmonary alveolar proteinosis: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2026
    Pooled it
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Chika NaritaMicrobiology Research Division, Kohjin Bio Co. Ltd., Saitama, Japan.
Kenjiro ShimaDepartment of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Jun-Ichiro SekiguchiMicrobiology Research Division, Kohjin Bio Co. Ltd., Saitama, Japan.
Yasuyuki OzekiQuality Assurance Division, Kohjin Bio Co. Ltd., Saitama, Japan.
Makoto AkiwaMicrobiology Research Division, Kohjin Bio Co. Ltd., Saitama, Japan.
Shohei KoikeMicrobiology Research Division, Kohjin Bio Co. Ltd., Saitama, Japan.
Sachiko YukiDivision of Molecular and Diagnostic Pathology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Keiichi AkasakaDepartment of Respiratory Medicine, Saitama Red Cross Hospital, Saitama, Japan.
Toshiaki KikuchiDepartment of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.ORCID 0000-0001-7428-1245
Nobutaka KitamuraGM-CSF Inhalation Promoting Organization, Tokyo, Japan.
Koh NakataGM-CSF Inhalation Promoting Organization, Tokyo, Japan.ORCID 0000-0001-6612-9497

Funding

Japan Agency for Medical Research and Development 17ek0109079h
6 · The paper itself

Abstract

BACKGROUND AND

objectivesAnti-GM-CSF autoantibodies (GMAbs) are essential biomarkers for diagnosing autoimmune pulmonary alveolar proteinosis (APAP). While enzyme-linked immunosorbent assay (ELISA) is commonly used, it is time-consuming and requires specialised equipment. We developed a novel immunochromatographic test (ICT) for rapid detection of GMAbs in clinical settings.

methodsICT was designed using a gold colloid aggregation method. The test line intensity was calibrated to be close to the ELISA cutoff of 1.65 U/mL using polyclonal anti-GM-CSF antibodies purified from the pooled patient sera. Validation was performed in 211 APAP and 171 non-APAP cases. The sensitivity, specificity, and correlation with ELISA were assessed.

resultsUsing known concentrations of serum from APAP patients, the grey zone concentration, which was difficult to judge by visual inspection, was found to be below 3.5 U/mL. In serological diagnosis of 211 cases with APAP and 171 cases with non-APAP lung diseases, the sensitivity and specificity by five examiners were 100% and 98.8%, respectively. When the GMAbs positive serum was serially diluted, the end point dilution titre showed a strong correlation overall (ρ = 0.93) with the antibody concentration determined by the conventional ELISA method, but the correlation was weaker in the low concentration range below 60 U/mL (ρ = 0.67), suggesting that the accuracy of ICT was reduced in the lower concentration range.

conclusionThis ICT offers a practical alternative to ELISA for APAP serological diagnosis. It enables rapid testing in clinical settings and supports the implementation of GM-CSF inhalation therapy.

Indexed as

AutoantibodiesAutoimmune DiseasesChromatography, AffinityGranulocyte-Macrophage Colony-Stimulating FactorPulmonary Alveolar ProteinosisAdultBiomarkersEnzyme-Linked Immunosorbent AssayFemaleHumansMaleMiddle AgedSensitivity and SpecificityAutoantibodiesBiomarkersGranulocyte-Macrophage Colony-Stimulating Factorautoimmune pulmonary alveolar proteinosisgranulocyte‐macrophage colony‐stimulating factorimmunochromatographic assay testserological diagnosis

Identifiers

PMID41121724
PMCPMC12865520

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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.