ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019
Diagnostic Accuracy of Early Secretory Antigenic Target-6-Free Interferon-gamma Release Assay Compared to QuantiFERON-TB Gold In-tube.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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14 citing papers in PubMed.
- Live-attenuated Mycobacterium tuberculosis vaccine, MTBVAC, in adults with or without M tuberculosis sensitisation: a single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial.The Lancet. Global health · 2025Trial
- Safety, reactogenicity, and immunogenicity of MTBVAC in infants: a phase 2a randomised, double-blind, dose-defining trial in a TB endemic setting.EBioMedicine · 2025Trial
- Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial.The Lancet. Child & adolescent health · 2023Trial
- Evaluation of an ESAT-6 Recombinant Skin Test Reagent for Bovine Tuberculosis Diagnosis in Guinea Pigs and Cattle.International journal of molecular sciences · 2026Article
- The blood biomarker combination IL-8/IL-33 and IL-18/IL-33 distinguish between active tuberculosis and latent infection.Infection · 2025Article
- Cost-effectiveness of screening with transcriptional signatures for incipient TB among U.S. migrants.PLoS medicine · 2025Article
- Synthesis of plant-based, self-adjuvanted, dual antigen specific to Mycobacterium tuberculosis as a novel tuberculosis subunit vaccine that elicits immunogenicity in rabbit.Biotechnology letters · 2023Article
- End-point definition and trial design to advance tuberculosis vaccine development.European respiratory review : an official journal of the European Respiratory Society · 2022Review
- Article
- Screening forFrontiers in cellular and infection microbiology · 2021Article
- Diagnostic benefits of adding EspC, EspF and Rv2348-B to the QuantiFERON Gold In-tube antigen combination.Scientific reports · 2020Article
- Progress in interferon-gamma release assay development and applications: an unfolding story of translational research.Annals of translational medicine · 2019Article
- Recombinant production of ESAT-6 antigen in thermoinducible Escherichia coli: the role of culture scale and temperature on metabolic response, expression of chaperones, and architecture of inclusion bodies.Cell stress & chaperones · 2019Article
- Clinical Development of New TB Vaccines: Recent Advances and Next Steps.Frontiers in microbiology · 2019Review
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Funding
Abstract
backgroundEarly secretory antigenic target-6 (ESAT-6) is an immunodominant Mycobacterium tuberculosis (M.tb) antigen included in novel vaccines against tuberculosis (TB) and in interferon-gamma (IFN-γ) release assays (IGRAs). Therefore, the availability of an ESAT-6-free IGRA is essential to determine M.tb infection status following vaccination with ESAT-6-containing vaccines. We aimed to qualify a recently developed ESAT-6-free IGRA and to assess its diagnostic performance in comparison to QuantiFERON-TB Gold In-tube (QFT).
methodsParticipants with different levels of M.tb exposure and TB disease were enrolled to determine the ESAT-6-free IGRA cutoff, test assay performance in independent cohorts compared to standard QFT, and perform a technical qualification of antigen-coated blood collection tubes.
resultsESAT-6-free IGRA antigen recognition was evaluated in QFT-positive and QFT-negative South African adolescents. The ESAT-6-free IGRA cutoff was established at 0.61 IU/mL, based on receiver operating characteristic analysis in M.tb-unexposed controls and microbiologically confirmed pulmonary TB patients. In an independent cohort of healthy adolescents, levels of IFN-γ released in QFT and ESAT-6-free IGRA were highly correlated (P < .0001, r = 0.83) and yielded comparable positivity rates, 41.5% and 43.5%, respectively, with 91% concordance between the tests (kappa = 0.82; 95% confidence interval, 0.74-0.90; McNemar test P = .48). ESAT-6-free IGRA blood collection tubes had acceptable lot-to-lot variability, precision, and stability.
conclusionsThe novel ESAT-6-free IGRA had diagnostic accuracy comparable to QFT and is suitable for use in clinical trials to assess efficacy of candidate TB vaccines to prevent established M.tb infection.
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