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Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients
This study is designed to evaluate the performance of a new ELISA based QuantiFERON-TB plus In-tube test to identify M. tuberculosis specific immune Responses as evidence of latent infection with M. tuberculosis in immunosuppressed populations. Both qualitative and quantitative test results will be related to the level of immunodeficiency and to the presence of risk factors for prior exposure with M. tuberculosis. In addition, patients with active tuberculosis (both immunocompetent and immunocompromised individuals) will be included to evaluate a potential increase in sensitivity in these groups. Immunocompetent individuals with low risk of exposure will be analysed as a proxy to estimate specificity. Finally, this study will be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunocompetent controls | Control persons without immunodeficiency with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | ||
| Solid organ transplant recipients | Patients after solid organ transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | ||
| Stem cell transplant recipients | Patients after stem cell transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | ||
| Patients with rheumatoid arthritis | Patients with rheumatoid arthritis with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | ||
| Patients with chronic renal failure | Patients with chronic renal failure with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis | ||
| Individuals with HIV infection | Individuals with HIV infection with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Specificity | The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure. | 2 years |
| Sensitivity | The percentage of positive test results will be quantified among controls and patients with active tuberculosis. | 2 years |
| Indeterminate results | The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients | 2 years |
| Association with exposure | Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure | 2 years |
| Progression | The number of individuals progressing to tuberculosis will be quantified depending on the test result at the time of screening and depending on preventive chemotherapy | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Immunocompetent and immunocompromised patients
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| Name | Affiliation | Role |
|---|---|---|
| Martina Sester, PhD | Universität des Saarlandes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Research center Borstel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40823191 | Derived | Sester M, Altet-Gomez N, Andersen AB, Arias-Guillen M, Avsar K, Bakken Kran AM, Bothamley G, Nordholm Breschel AC, Brown J, Chesov D, Ciobanu N, Cirillo DM, Crudu V, de Souza Galvao M, Dilektasli AG, Dominguez J, Duarte R, Dyrhol-Riise AM, Goletti D, Hoffmann H, Ibraim E, Kalsdorf B, Krawczyk M, Kunst H, Lange B, Lipman M, Matteelli A, Milkiewicz P, Neyer D, Nitschke M, Oral HB, Palacios-Gutierrez JJ, Petruccioli E, Raszeja-Wyszomirska J, Ravn P, Rupp J, Spohn HE, Toader C, Villar-Hernandez R, Wagner D, van Leth F, Martinez L, Pedersen OS, Lange C. Diagnostic accuracy and predictive value of the QuantiFERON-TB gold plus assay for tuberculosis in immunocompromised individuals: a prospective TBnet study. Lancet Reg Health Eur. 2025 Aug 6;57:101416. doi: 10.1016/j.lanepe.2025.101416. eCollection 2025 Oct. |
| Label | URL |
|---|---|
| TBnet website | View source |
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Stimulated plasma samples
| Borstel |
| Germany |
| Freiburg University | Freiburg im Breisgau | 79100 | Germany |
| Saarland University | Homburg | 66421 | Germany |
| University of Brescia and Brescia Spedali Civili General Hospital | Brescia | Italy |
| San Raffaele Scientific institute | Milan | 20132 | Italy |
| National Institute for Infectious Diseases L. Spallanzani | Rome | 00149 | Italy |
| Department of Pneumology & Allergology | Chisinau | 2004 | Moldova |
| Department of Infectious Diseases; Oslo University | Oslo | 0450 | Norway |
| Warszawski Uniwersytet Medyczny | Warsaw | 02-097 | Poland |
| Centro de Diagnóstico Pneumológico | Vila Nova de Gaia | Portugal |
| Marius Nasta Institute of Pneumology | Bucharest | Sector 5 | 5 | Romania |
| Institut d'Investigació Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08001 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33001 | Spain |
| Department of Respiratory Medicine, Royal Free Hospital | London | NW3 2QG | United Kingdom |
| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
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