Evidence map›Paper›PMID 29856871›Full record

ArticlePloS one2018

Novel M. tuberculosis specific IL-2 ELISpot assay discriminates adult patients with active or latent tuberculosis.

Chiara Della Bella, Michele Spinicci, Alessia Grassi, Filippo Bartalesi, Marisa Benagiano, Katja Truthmann, Simona Tapinassi, Arianna Troilo, Sofia D'Elios, Heba Alnwaisri and 4 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 12% 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

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.

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  15. Journal of clinical tuberculosis and other mycobacterial diseases · 2019
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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

14 authors at 5 institutions in 3 countries.

Chiara Della BellaDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Michele SpinicciDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Alessia GrassiDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Filippo BartalesiInfectious and Tropical Diseases Unit, Florence Careggi University Hospital, Florence, Italy.
Marisa BenagianoDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Katja TruthmannLIONEX Diagnostics and Therapeutics GmbH, Braunschweig, Germany.
Simona TapinassiDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Arianna TroiloDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Sofia D'EliosDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Heba AlnwaisriDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Eduard ShuralevInstitute of Environmental Sciences, Kazan Federal University, and Central Research Laboratory, Kazan State Medical Academy, and Federal Center for Toxicological, Radiation and Biological Safety, Kazan, Tatarstan, Russian Federation.ORCID 0000-0003-0650-3090
Mahavir SinghLIONEX Diagnostics and Therapeutics GmbH, Braunschweig, Germany.
Alessandro BartoloniInfectious and Tropical Diseases Unit, Florence Careggi University Hospital, Florence, Italy.
Mario Milco D'EliosDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.ORCID 0000-0001-9160-0930
University of Florence · ITAzienda Ospedaliero-Universitaria Careggi · ITLionex (Germany) · DEKazan Federal University · RUUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTuberculosis (TB) still is a major worldwide health problem, with 10.4 million new cases in 2016. Only 5-15% of people infected with M. tuberculosis develop TB disease while others remain latently infected (LTBI) during their lifetime. Thus, the absence of tests able to distinguish between latent infection and active tuberculosis is one of the major limits of currently available diagnostic tools.

methodsA total of 215 patients were included in the study as active TB cases (n = 73), LTBI subjects (n = 88) and healthy persons (n = 54). Peripheral blood mononuclear cells (PBMCs) were isolated from each patient and the LIOSpot® TB anti-human IL-2 ELISpot assay was performed to test their proliferative response to M. tuberculosis antigens ESAT-6, CFP-10 and Ala-DH. Statistical analysis was performed to define the sensitivity and the specificity of the LIOSpot® TB kit for each antigen used and to set the best cut off value that enables discrimination between subjects with active TB or latent TB infection.

resultsComparing the LIOSpot® TB results for each tested antigen between uninfected and infected subjects and between people with latent infection and active TB disease, the differences were significant for each antigen (p< 0.0001) but the ROC analysis demonstrated a high accuracy for the Ala-DH test only, with a cut off value of 12.5 SFC per million PBMCs and the Ala-DH ROC curve conferred a 96% sensitivity and 100% specificity to the test. For the ESAT-6 antigen, with a best cut off value of 71.25 SFC per million PBMCs, a sensitivity of 86% and specificity of 36% was obtained. Finally, the best cut off value for CFP-10 was 231.25 SFC per million PBMCs, with a sensitivity of 80% and a specificity of 54%. Thus, as for IGRA assays such as Quantiferon and T-Spot TB tests, ESAT-6 and CFP-10 are unable to distinguish LTBI from active TB when IL-2 is measured. On the contrary, the IL-2 production induced by Ala-DH, measured by LIOSpot® TB kit, shows high sensitivity and specificity for active TB disease.

conclusionsThis study demonstrates that the LIOSpot® TB test is a highly useful diagnostic tool to discriminate between latent TB infection and active tuberculosis in adults patients.

Indexed as

AdultAgedCase-Control StudiesDiagnosis, DifferentialFemaleHumansImmunoassayInterleukin-2Latent TuberculosisMaleMiddle AgedMycobacterium tuberculosisROC CurveSpecies SpecificityInterleukin-2

Identifiers

PMID29856871
PMCPMC5983515
OpenAlexW2805053797

What OpenQuestion holds

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LicenceCC BY
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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.