Evidence map›Paper›PMID 34162973›Full record

ArticleScientific reports2021

Case-control diagnostic accuracy study of a non-sputum CD38-based TAM-TB test from a single milliliter of blood.

Hellen Hiza, Jerry Hella, Ainhoa Arbués, Beatrice Magani, Mohamed Sasamalo, Sebastien Gagneux, Klaus Reither, Damien Portevin

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
1.2field-weighted citation impact, top 18% 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

19 citing papers in PubMed, 23 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Correlation Between CD38Diabetes, metabolic syndrome and obesity : targets and therapy · 2025
    Article
  6. Diagnostic accuracy of a sequence-specificMicrobiology spectrum · 2024
    Article
  7. Review
  8. Evaluation of immunodominant peptides of in vivo expressed mycobacterial antigens in an ELISA-based diagnostic assay for pulmonary tuberculosis.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2023
    Article
  9. Review
  10. Trends and challenges of multi-drug resistance in childhood tuberculosis.Frontiers in cellular and infection microbiology · 2023
    Review
  11. Review
  12. Article
  13. Pediatric Tuberculosis Diagnostics: Present and Future.Journal of the Pediatric Infectious Diseases Society · 2022
    Article
  14. Review
  15. Review
  16. Review
  17. Diagnosing Tuberculosis: What Do New Technologies Allow Us to (Not) Do?Respiration; international review of thoracic diseases · 2022
    Review
  18. Article
  19. Article
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

8 authors at 3 institutions in 2 countries.

Hellen HizaIfakara Health Institute, Bagamoyo, Tanzania.
Jerry HellaIfakara Health Institute, Bagamoyo, Tanzania.
Ainhoa ArbuésSwiss Tropical and Public Health Institute, Basel, Switzerland.
Beatrice MaganiIfakara Health Institute, Bagamoyo, Tanzania.
Mohamed SasamaloIfakara Health Institute, Bagamoyo, Tanzania.
Sebastien GagneuxSwiss Tropical and Public Health Institute, Basel, Switzerland.
Klaus ReitherSwiss Tropical and Public Health Institute, Basel, Switzerland.
Damien PortevinSwiss Tropical and Public Health Institute, Basel, Switzerland. damien.portevin@swisstph.ch.
University of Basel · CHSwiss Tropical and Public Health Institute · CHIfakara Health Institute · TZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CD4 T cell phenotyping-based blood assays have the potential to meet WHO target product profiles (TPP) of non-sputum-biomarker-based tests to diagnose tuberculosis (TB). Yet, substantial refinements are required to allow their implementation in clinical settings. This study assessed the real time performance of a simplified T cell activation marker (TAM)-TB assay to detect TB in adults from one millilitre of blood with a 24 h turnaround time. We recruited 479 GeneXpert positive cases and 108 symptomatic but GeneXpert negative controls from presumptive adult TB patients in the Temeke District of Dar-es-Salaam, Tanzania. TAM-TB assay accuracy was assessed by comparison with a composite reference standard comprising GeneXpert and solid culture. A single millilitre of fresh blood was processed to measure expression of CD38 or CD27 by CD4 T cells producing IFN-γ and/or TNF-α in response to a synthetic peptide pool covering the sequences of Mycobacterium tuberculosis (Mtb) ESAT-6, CFP-10 and TB10.4 antigens on a 4-color FACSCalibur apparatus. Significantly superior to CD27 in accurately diagnosing TB, the CD38-based TAM-TB assay specificity reached 93.4% for a sensitivity of 82.2% with an area under the receiver operating characteristics curve of 0.87 (95% CI 0.84-0.91). The assay performance was not significantly affected by HIV status. To conclude, we successfully implemented TAM-TB immunoassay routine testing with a 24 h turnaround time at district level in a resource limited setting. Starting from one millilitre of fresh blood and being not influenced by HIV status, TAM-TB assay format and performance appears closely compatible with the optimal TPP accuracy criteria defined by WHO for a non-sputum confirmatory TB test.

Indexed as

AdolescentADP-ribosyl Cyclase 1AdultArea Under CurveCase-Control StudiesCD4-Positive T-LymphocytesCigarette SmokingComputer SystemsFemaleHIV InfectionsHumansInterferon-gammaLymphocyte ActivationMaleMembrane GlycoproteinsMiddle AgedADP-ribosyl Cyclase 1CD38 protein, humanIFNG protein, humanInterferon-gammaMembrane GlycoproteinsTumor Necrosis Factor-alpha

Identifiers

PMID34162973
PMCPMC8222251
OpenAlexW3139040617

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.