Evidence map›Paper›PMID 15817755›Full record

Trial reportClinical and diagnostic laboratory immunology2005

Prospective evaluation of a whole-blood test using Mycobacterium tuberculosis-specific antigens ESAT-6 and CFP-10 for diagnosis of active tuberculosis.

Pernille Ravn, Martin E Munk, Ase B Andersen, Bettina Lundgren, Jens D Lundgren, Lars N Nielsen, Axel Kok-Jensen, Peter Andersen, Karin Weldingh

6 registry-linked trialsAbstract readClinical TrialComparative Study
In one paragraph

Trial report in Clinical and diagnostic laboratory immunology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 46 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 1 pooled it
–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.

NCT01999231 phase1completednot on this mapstarted 2013, after this paper: background citation

Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

TypeinterventionalSponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Ran2013 to 2013Enrolled32ConditionsHealthyArmsESAT6-CFP10
NCT02329730 phase2completednot on this mapstarted 2014, after this paper: background citation

Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Antigen ESAT6-CFP10

TypeinterventionalSponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Ran2014 to 2014Enrolled144ConditionsTuberculosisArms1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative, 1μg/ml ESAT6-CFP10 and placebo
NCT02336542 phase2completednot on this mapstarted 2014, after this paper: background citation

For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase IIb Clinical Research

TypeinterventionalSponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Ran2014 to 2015Enrolled192ConditionsTuberculosisArms5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm, 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm, 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm
NCT02389322 phase2completednot on this mapstarted 2015, after this paper: background citation

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method

TypeinterventionalSponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Ran2015 to 2015Enrolled1,044ConditionsTuberculosisArms5μg/ml ESAT6-CFP10, 10μg/ml ESAT6-CFP10, BCG, placebo
NCT02623556 phase3completednot on this mapstarted 2015, after this paper: background citation

For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase III Clinical Research

TypeinterventionalSponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Ran2015 to 2018Enrolled1,090ConditionsTuberculosisArmsESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm, ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
NCT02795260 phase3completednot on this mapstarted 2016, after this paper: background citation

Phase III Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method

TypeinterventionalSponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Ran2016 to 2016Enrolled1,802ConditionsTuberculosisArmsBacillus Calmette - Guerin, placebo of Bacillus Calmette - Guerin
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Cutaneous Manifestations ofPathogens (Basel, Switzerland) · 2023
    Review
  7. Article
  8. Contact investigation after a fatal case of extensively drug-resistant tuberculosis (XDR-TB) in an aircraft, Germany, July 2013.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2017
    Article
  9. Article
  10. Pulmonary Tuberculosis Diagnosis: Where We Are?Tuberculosis and respiratory diseases · 2016
    Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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

9 authors.

Pernille RavnDepartment of Infectious Diseases, Hvidovre Hospital, Kettegårds Alle 30, 2650 Hvidovre, Copenhagen, Denmark. pravn@dadlnet.dk
Martin E Munk
Ase B Andersen
Bettina Lundgren
Jens D Lundgren
Lars N Nielsen
Axel Kok-Jensen
Peter Andersen
Karin Weldingh

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A new immunodiagnostic test based on the Mycobacterium tuberculosis-specific antigens CFP-10/ESAT-6(QFT-RD1) has been launched as an aid in the diagnosis of latent tuberculosis (TB) infection (LTBI). The aim of this study was to evaluate this test for the diagnosis of active TB. Eighty-two patients with suspicion of TB and 39 healthy BCG-vaccinated persons were enrolled. Forty-eight had active TB, 25 did not, and 9 were excluded. Sensitivity and specificity of the test for active TB were evaluated in a prospective blinded manner in patients suspected of TB. The sensitivity of the QFT-RD1 was 85% (40/48; confidence interval [CI], 75 to 96), and it was higher than the sensitivity of microscopy, 42% (20/48; CI, 27 to 56; P = 0.001), and culture, 59% (27/46; CI, 44 to 73; P = 0.009). Of patients with extrapulmonary TB, 92% (12/13) were QFT-RD1 positive, whereas only 31% (4/13) were positive by microscopy and 42% (5/12) by culture (P < 0.05), and 87% (13/15) of those who were negative by both microscopy and culture were QFT-RD1 positive. By combining microscopy and culture with the QFT-RD1 test, sensitivity increased to 96% (CI, 90 to 102). Ten of 25 (40%) non-TB patients were QFT-RD1 positive, resulting in a specificity of 60%. However, 80% (8/10) of these had risk-factors for TB, indicating latent infection in this group. In healthy controls, only 3% (1/39) were QFT-RD1 positive. In conclusion, the QFT-RD1 test is sensitive for diagnosis of TB, especially in patients with negative microscopy and culture. The accuracy of the QFT-RD1 test will vary with the prevalence of LTBI. We suggest that the QFT-RD1 test could be a very useful supplementary tool for the diagnosis of TB.

Indexed as

Antigens, BacterialBacterial ProteinsAdultAnimalsBCG VaccineCulture TechniquesEvaluation Studies as TopicFemaleHumansMaleMiddle AgedProspective StudiesSensitivity and SpecificitySingle-Blind MethodTuberculinTuberculin TestAntigens, BacterialBacterial ProteinsBCG VaccineCFP-10 protein, Mycobacterium tuberculosisESAT-6 protein, Mycobacterium tuberculosisMycobacterium tuberculosis antigensTuberculin

Identifiers

PMID15817755
PMCPMC1074386

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.