What is the sensitivity of the QuantiFERON‑TB Gold Plus (QFT‑Plus) interferon‑gamma release assay for detecting Mycobacterium tuberculosis infection overall, in patients with microbiologically proven active tuberculosis, and in immunocompromised or elderly individuals?

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QuantiFERON Test Sensitivity

The QuantiFERON-TB Gold Plus (QFT-Plus) demonstrates a pooled sensitivity of approximately 81-83% for detecting culture-confirmed active tuberculosis in adults, with specificity of 96-99%, though sensitivity may be reduced to 73% in immunocompromised patients and performance in elderly populations remains variable. 1

Overall Sensitivity in Active Tuberculosis

  • Pooled sensitivity across multiple studies for QFT-GIT (the predecessor to QFT-Plus) was 81% when calculated from patients with culture-confirmed active tuberculosis, meaning approximately 19% of true TB cases will test negative. 1

  • When comparing QFT-GIT directly to tuberculin skin test (TST) in culture-confirmed cases, pooled sensitivity was 83% for QFT-GIT versus 89% for TST, showing TST maintains slightly higher sensitivity. 1

  • The newer QFT-Plus demonstrates sensitivity of 94-99% in recent high-quality studies from Japan, representing a potential improvement over QFT-GIT, though this requires validation in broader populations. 2, 3

  • A systematic review and meta-analysis found QFT-Plus overall sensitivity of 94% (95% CI 89-97%) with specificity of 96% (95% CI 94-98%), though these figures include both active TB and latent TB infection populations. 3

Sensitivity in Immunocompromised Patients

  • In immunocompromised patients with active tuberculosis, sensitivity drops substantially to approximately 73%, with indeterminate results occurring in up to 21% of hospitalized immunocompromised patients. 1, 4

  • The test's sensitivity and indeterminate rate in immunocompromised populations has not been adequately established, representing a critical limitation when interpreting negative results in HIV-positive patients, those on TNF-alpha antagonists, organ transplant recipients, or patients with hematologic malignancies. 1, 5

  • One study specifically found QFT-Plus sensitivity of 72.7% in immunocompromised active TB patients compared to 86.4% in non-immunocompromised patients, with immunosuppression also increasing indeterminate results. 4

  • A negative QFT result cannot exclude M. tuberculosis infection in immunocompromised individuals, and clinical judgment incorporating epidemiologic exposure, symptoms, chest radiography, and bacteriologic studies must guide management. 6, 5

Sensitivity in Elderly Populations

  • QFT-Plus demonstrated 93.6% sensitivity in elderly patients with active pulmonary tuberculosis (median age 84 years), significantly outperforming T-SPOT.TB which showed only 68.1% sensitivity in this population. 7

  • Among elderly active TB patients with CD4 T-cell counts <200/μL (39 of whom were ≥80 years), QFT-Plus maintained 83.7% sensitivity compared to 74.4% for QFT-GIT and 58.1% for T-SPOT. 7

  • A meta-analysis found QFT-Plus demonstrated higher sensitivity than QFT-GIT specifically in older adults, suggesting the addition of the TB2 antigen tube (which stimulates CD8 T-cells) may improve detection in this population. 3

Critical Clinical Caveats

  • QFT-Plus cannot differentiate active tuberculosis from latent TB infection, and therefore must never be used as a sole diagnostic test for active disease—chest radiography, sputum AFB smear, and mycobacterial culture remain mandatory for diagnosing active TB. 8, 5

  • The 81-83% sensitivity means that 6-26% of true active TB cases will be missed if relying on QFT testing alone, making negative results insufficient to rule out disease when clinical suspicion exists. 1, 8

  • Indeterminate results occur due to inadequate mitogen response (IFN-γ ≤0.5 IU/mL in positive control) or high background IFN-γ (>8 IU/mL in nil control), requiring repeat testing with a new specimen or TST in high-risk patients. 6

  • Severe diabetes mellitus may produce false-negative results on all IGRAs, as demonstrated by cases showing negative results across QFT-Plus, QFT-GIT, and T-SPOT in patients with uncontrolled diabetes. 2

Comparison to Other Tests

  • T-SPOT.TB demonstrates pooled sensitivity of 90-91% in culture-confirmed active tuberculosis, performing slightly better than QFT-GIT (81-83%) but with similar performance to TST (89%). 1

  • In the largest head-to-head comparison involving 270+ patients with culture-confirmed TB, T-SPOT and TST showed similar sensitivity (94% and 95% respectively), both significantly higher than QFT-GIT (83%, p<0.01). 1

  • QFT-Plus and QFT-GIT show substantial agreement (89.9-96.0%, kappa 0.80-0.91) in high-risk populations, with sensitivity differences ranging only -4.0% to +2.0% across studies. 9

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Sensitivity and specificity of QuantiFERON-TB Gold Plus compared with QuantiFERON-TB Gold In-Tube and T-SPOT.TB on active tuberculosis in Japan.

Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, 2018

Research

Evaluation of the performance of QuantiFERON®-TB Gold plus test in active tuberculosis patients.

Journal of clinical tuberculosis and other mycobacterial diseases, 2021

Guideline

Clinical Significance of TB Gold Test from Plasma

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

Management of Indeterminate QuantiFERON Gold Plus Results

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

Limitations and Appropriate Use of QuantiFERON‑TB Gold (QFT‑G) in Tuberculosis Diagnosis

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Research

Fourth-Generation QuantiFERON-TB Gold Plus: What Is the Evidence?

Journal of clinical microbiology, 2020

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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