Evidence map›Paper›PMID 33666781›Full record

ArticleClinical rheumatology2021

Evaluation of a lateral flow assay-based IFN-γ release assay as a point-of-care test for the diagnosis of latent tuberculosis infection.

Hoon Hee Lee, Dong Hwan Choi, Jeong-Ran Kim, Young Gyun Kim, Kyung-Wook Jo, Tae Sun Shim

Open access · hybridAbstract read
PubMed Publisher
In one paragraph

Article in Clinical rheumatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.3field-weighted citation impact, top 40% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Diagnostic Performance of New Commercial Interferon-Gamma Release Assays for Mycobacterium tuberculosis Infection: An Updated Systematic Review and Meta-analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Pooled it
  2. Pooled it
  3. Article
  4. 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

6 authors at 3 institutions in 1 country.

Hoon Hee LeeDivision of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.ORCID https://orcid.org/0000-0003-2926-2197
Dong Hwan ChoiR&D Center, Boditech Med Inc., Chuncheon, South Korea.ORCID https://orcid.org/0000-0001-9404-0107
Jeong-Ran KimDepartment of Research and Development, The Korean Institute of Tuberculosis, Cheongju, South Korea.ORCID https://orcid.org/0000-0001-6267-2046
Young Gyun KimAB Medical Inc., Jangseong, South Korea.
Kyung-Wook JoDivision of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.ORCID https://orcid.org/0000-0002-5949-248X
Tae Sun ShimDivision of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea. shimts@amc.seoul.kr.ORCID http://orcid.org/0000-0001-6653-816X
Ulsan College · KRABL Bio (South Korea) · KRBoditech Med (South Korea) · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe compared the performance of a fluorescence lateral flow assay (ichroma™ IGRA-TB) with the QuantiFERON-TB Gold PLUS (QFT-PLUS) for the diagnosis of latent tuberculosis infection (LTBI) in patients with immune-mediated inflammatory diseases (IMID) prior to receiving biologics therapy.

methodThe comparability of the ichroma™ IGRA-TB assay with the QFT-PLUS assay for the diagnosis of LTBI was determined in prospectively enrolled patients with IMID prior to receiving biologics between August 2018 and October 2019. To determine the best cut-off value of the ichroma™ IGRA-TB, an ROC curve analysis was performed.

resultsPatients with IMID (n = 145) had inflammatory bowel disease (n = 83; 57.2%), rheumatoid arthritis (n = 44; 30.3%), or spondyloarthropathy (n = 18; 12.4%). The median age was 40.5 (interquartile range: 27.0-56.0), 72 (49.7%) were men, and 140 (96.6%) received BCG vaccination. With the manufacturer-recommended cut-off values, 11 (7.6%) and 20 (13.8%) patients showed positive results with the ichroma™ IGRA-TB and QFT-PLUS tests, respectively. The overall agreement between the two tests was 91.0% with a Cohen's kappa value of 0.535 (95% confidence interval: 0.317-0.754). ROC curve analysis of the QFT-PLUS results showed that a cut-off value of > 0.21 IU/mL would improve the performance of the ichroma™ IGRA-TB. Using the new cut-off value, the concordance rate was improved to 93.1% with a Cohen's kappa value of 0.668 (95% confidence interval: 0.478-0.858).

conclusionsThe ichroma™ IGRA-TB could be used as a point-of-care test for LTBI screening in IMID patients before starting biologics, especially in resource-limited settings. Key Points • The ichroma™ IGRA-TB is an automated fluorescence lateral flow assay-based IGRA. • The test has advantages like short turn-around time, low-cost, and ease of use. • The ichroma™ IGRA-TB showed high agreement with the QuantiFERON-TB Gold In-Tube in patients with chronic immune-mediated inflammatory diseases before starting biologics.

Indexed as

Latent TuberculosisAdultHumansInterferon-gammaInterferon-gamma Release TestsMalePoint-of-Care TestingROC CurveTuberculin TestInterferon-gammaImmune-mediated inflammatory diseasesInterferon-gamma release testsLatent tuberculosisPoint-of-care testing

Identifiers

PMID33666781
OpenAlexW3135289134

What OpenQuestion holds

Textmetadata
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.