Evidence map›Paper›PMID 41551847›Full record

ArticleIJID regions2026

Agreement and systematic bias between QuantiFERON chemiluminescent immunoassay and QuantiFERON enzyme-linked immunosorbent assay in the detection of latent tuberculosis infection: A systematic review and meta-analysis.

Felix Bongomin, Ivaan Pitua, Phillip Ssekamatte, Diana Sitenda, Irene Andia-Biraro, Bwambale Jonani

Abstract read
In one paragraph

Article in IJID regions, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
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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

6 authors.

Felix BongominDepartment of Medical Microbiology and Immunology, Faculty of Medicine, Gulu University, Gulu, Uganda.
Ivaan PituaDepartment of Internal Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
Phillip SsekamatteTuberculosis and Comorbidities Research Consortium, Kampala, Uganda.
Diana SitendaTuberculosis and Comorbidities Research Consortium, Kampala, Uganda.
Irene Andia-BiraroDepartment of Internal Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
Bwambale JonaniDepartment of Immunology and Molecular Biology, School of Biomedical Sciences, College of Health Sciences, Makerere University, Kampala, Uganda.

Funding

Minnesota-Makerere-Mbarara Neuro-Infectious Disease Research Training ConsortiumD43TW012266 · FIC · UNIVERSITY OF MINNESOTA · PI David R Boulware, David Bisagaya Meya · 2024 to 2026
$747k
FIC NIH HHS D43 TW012266
6 · The paper itself

Abstract

objectivesEnzyme-linked immunosorbent assay (ELISA)-based QuantiFERON-TB Gold Plus (QFT-Plus ELISA) testing is associated with manual variability and indeterminate results. The transition from QFT-Plus ELISA to chemiluminescent immunoassay (CLIA) for QuantiFERON-TB Gold Plus (QFT-Plus CLIA) testing represents a significant methodological evolution that requires comprehensive evaluation. This systematic review and meta-analysis aimed to assess method agreement, characterize systematic bias patterns, evaluate clinical concordance between DiaSorin's QFT-Plus CLIA and QIAGEN's (QFT-Plus ELISA) methodologies, and determine sources of heterogeneity across diverse populations for latent tuberculosis infection (LTBI) detection.

methodsWe searched the PubMed, Embase, and Google Scholar databases from January 2019 to January 2025 for studies comparing QFT-Plus CLIA and QFT-Plus ELISA methodologies for LTBI detection. Two reviewers independently screened the studies and assessed their quality using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. We conducted a meta-analysis of agreement measures using random-effects models, systematic bias characterization, meta-regression analysis of the sources of heterogeneity, and clinical subgroup analysis. Evidence certainty was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). The review was registered with PROSPERO (CRD420251031884).

resultsA total of 16 studies comprising 4169 participants were included. A meta-analysis of 10 studies (n = 2932) revealed a substantial overall concordance of 88.76% (95% confidence interval [CI] 83.57-93.95). Among the seven studies with complete data to calculate positive and negative agreement measures (n = 1305), the pooled positive agreement was 91.3% (95% CI 88.95-93.65) and the negative agreement was 93.89% (95% CI 92.18-95.6). The comparative analysis revealed a mean discordance rate of 6.56% (range: 0.44-16.67%), with a weighted mean directional bias of +0.2% (showing minimal overall directional preference between platforms). Significant heterogeneity was observed (I² = 95.8%,

conclusionsDiasorin's QFT-Plus CLIA and QIAGEN's QFT-Plus ELISA demonstrated substantial overall agreement in detecting LTBI, with the strongest concordance for clearly positive and negative results. Laboratories implementing QFT-Plus CLIA platforms should consider verification studies, and future research should evaluate the clinical significance of discordant results and optimize interpretive algorithms for diverse epidemiologic settings.

Indexed as

Agreement analysisCLIAELISALatent tuberculosisMethod comparisonQuantiFERON

Identifiers

PMID41551847
PMCPMC12809075

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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.