Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022
Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers.
What it found
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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.
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.
For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase IIb Clinical Research
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method
Who cites it
25 citing papers in PubMed.
- Safety, tolerability, and concordance with interferon-γ release assays of a recombinant ESAT6-MPT64 skin test: a phase 1 randomized clinical trial.Frontiers in immunology · 2026Trial
- Accuracy of ESAT6-CFP10 skin test compared with tuberculin skin test in a healthy population: a randomized, blind, parallel controlled phase III clinical study.BMC infectious diseases · 2024Trial
- Safety of a Novel ESAT6-CFP10 skin test compared with tuberculin skin test in a double-blind, randomized, controlled study.BMC infectious diseases · 2022Trial
- Current laboratory diagnostics for tuberculosis: from conventional approaches to next-generation molecular and immunological technologies.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Review
- Mycobacterium tuberculosis transmission from tuberculosis patients with and without recognized symptoms: a case-contact study in eastern China.Nature communications · 2026Article
- Rv1983 promotes mycobacterial dissemination by triggering ferroptosis through GPX4 ubiquitination.Cellular & molecular biology letters · 2026Article
- Dynamic, quantitative ESAT6-CFP10 skin test for tuberculosis risk prediction: a large-scale, multi-center, prospective cohort study.The Lancet regional health. Western Pacific · 2026Article
- Tuberculosis infection and related factors among 15-17 years old teenagers in Eastern China.BMC public health · 2026Article
- Early Mycobacterial Antigens in the Immunodiagnosis of Latent Tuberculosis Infection.Pathogens (Basel, Switzerland) · 2026Review
- Peripheral cytokine distinguish recent fromFrontiers in microbiology · 2026Article
- Analysis of the current status and influencing factors of latent tuberculosis infection among new students in Taishan District in 2025.Frontiers in public health · 2026Article
- Prevalence and risk factors of latent tuberculosis infection in healthcare workers in Eastern China.BMC public health · 2025Article
- The Impact of Body Mass Index on Latent Tuberculosis Infection: Combined Assessment in People Living with HIV.Pathogens (Basel, Switzerland) · 2025Article
- Comparative evaluation of QuantiFERON-TB gold in-tube plus for Mycobacterium tuberculosis infection among adolescents in China.BMC public health · 2025Article
- Epidemiological features of tuberculosis infection in a high-altitude population: a population-based, cross-sectional survey in Tibet, China.Frontiers in cellular and infection microbiology · 2025Article
- Effect of CD4 count on Mycobacterium tuberculosis infection rates in people living with HIV: a comparative study in prison and community.Scientific reports · 2024Article
- Evaluation of Latent Tuberculosis Infection Using the ESAT6-CFP10 Skin Test Among International Freshmen With Diverse Skin Tones at a University - Nanjing City, Jiangsu Province, China, September 2023.China CDC weekly · 2024Article
- Overlooked, dismissed, and downplayed: reversion ofEuropean respiratory review : an official journal of the European Respiratory Society · 2024Review
- From immunology to artificial intelligence: revolutionizing latent tuberculosis infection diagnosis with machine learning.Military Medical Research · 2023Review
- A Comparative Study on the Mechanism of Delayed-Type Hypersensitivity Mediated by the RecombinantInternational journal of molecular sciences · 2023Article
Corrections and comments
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Authors and funding
24 authors.
Funding
Abstract
backgroundDiagnostics to identify tuberculosis infection are limited. We aimed to assess the diagnostic accuracy and safety of ESAT6-CFP10 (EC) skin test for tuberculosis infection in Chinese adults.
methodsWe conducted 2 randomized, parallel-group clinical trials in healthy participants and tuberculosis patients. All participants were tested with the T-SPOT.TB test, then received an EC skin test and tuberculin skin test (TST). The diameter of skin indurations and/or redness at injection sites were measured at different time periods. A bacillus Calmette Guerin (BCG) model was established to assess the diagnosis of tuberculosis infection using an EC skin test.
resultsIn total, 777 healthy participants and 96 tuberculosis patients were allocated to receive EC skin test at 1.0 μg/0.1 mL or 0.5 μg/0.1 mL. The area under the curve was 0.95 (95% confidence interval [CI], .91-.97) for the EC skin test at 1.0 μg/0.1 mL at 24-72 hours. Compared with the T-SPOT.TB test, the EC skin test demonstrated similar sensitivity (87.5, 95% CI, 77.8-97.2 vs 86.5, 95% CI, 79.5-93.4) and specificity (98.9, 95% CI, 96.0-99.9 vs 96.1, 95% CI, 93.5-97.8). Among BCG vaccinated participants, the EC skin test had high consistency with the T-SPOT.TB test (96.3, 95% CI, 92.0-100.0). No serious adverse events related to the EC skin test were observed.
conclusionsThe EC skin test demonstrated both high specificity and sensitivity at a dose of 1.0 μg/0.1 mL, comparable to the T-SPOT.TB test. The diagnostic accuracy of the EC skin test was not impacted by BCG vaccination. CLINICAL TRIALS REGISTRATION: NCT02389322 and NCT02336542.
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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.