Evidence map›Paper›PMID 33479110›Full record

ArticleThe European respiratory journal2021

Framework for the evaluation of new tests for tuberculosis infection.

Yohhei Hamada, Saskia den Boon, Daniela Maria Cirillo, Adam Penn-Nicholson, Morten Ruhwald, Dick Menzies, Olivia Oxlade, Dennis Falzon, Avinash Kanchar, Alexei Korobitsyn and 3 more

Abstract read
In one paragraph

Article in The European respiratory journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Article
  2. Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  3. Article
  4. Article
  5. Article
  6. Overlooked, dismissed, and downplayed: reversion ofEuropean respiratory review : an official journal of the European Respiratory Society · 2024
    Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. TB preventive treatment in high- and intermediate-incidence countries: research needs for scale-up.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2021
    Article
  13. 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

13 authors.

Yohhei HamadaResearch Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan y.hamada@ucl.ac.uk.ORCID 0000-0002-9845-4267
Saskia den BoonGlobal TB Programme, World Health Organization, Geneva, Switzerland.
Daniela Maria CirilloIRCCS San Raffaele Scientific Institute, Milan, Italy.ORCID 0000-0001-6415-1535
Adam Penn-NicholsonFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Morten RuhwaldFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Dick MenziesMcGill International TB Centre, Montreal, QC, Canada.
Olivia OxladeMcGill International TB Centre, Montreal, QC, Canada.
Dennis FalzonGlobal TB Programme, World Health Organization, Geneva, Switzerland.
Avinash KancharGlobal TB Programme, World Health Organization, Geneva, Switzerland.
Alexei KorobitsynGlobal TB Programme, World Health Organization, Geneva, Switzerland.
Matteo ZignolGlobal TB Programme, World Health Organization, Geneva, Switzerland.
Alberto MatteelliCollaborating Centre for TB/HIV Co-infection and TB Elimination, Dept of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy.
Tereza KasaevaGlobal TB Programme, World Health Organization, Geneva, Switzerland.

Funding

Department of Health RP-PG-0217-20009World Health Organization 001
6 · The paper itself

Abstract

The scale-up of tuberculosis (TB) preventive treatment (TPT) must be accelerated to achieve the targets set by the United Nations High-level Meeting on TB and the End TB Strategy. The scale-up of effective TPT is hampered by concerns about operational challenges to implement the existing tests for TB infection. New simpler tests could facilitate the scale-up of testing for TB infection. We present a framework for evaluation of new immunodiagnostic tests for the detection of TB infection, with an aim to facilitate their standardised evaluation and accelerate adoption into global and national policies and subsequent scale-up. The framework describes the principles to be considered when evaluating new tests for TB infection and provides guidance to manufacturers, researchers, regulators and other users on study designs, populations, reference standards, sample size calculation and data analysis and it is also aligned with the Global Strategy for TB Research and Innovation adopted by the World Health Assembly in 2020. In addition, we briefly describe technical issues that should be considered when evaluating new tests, including the safety for skin tests, costs incurred by patients and the health system, and operational characteristics.

Indexed as

Latent TuberculosisTuberculosisGlobal HealthHumansReference Standards

Identifiers

PMID33479110
PMCPMC8374690

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.