Volatile Organic Compound Identification-Based Tuberculosis Screening among TB Suspects: A Diagnostic Accuracy Study.

Area of Science:

• Infectious Diseases
• Diagnostic Technology
• Public Health

Background:

• Tuberculosis (TB) impacts a significant portion of the global population, with many cases remaining undiagnosed.
• Accurate and accessible TB detection is crucial for achieving the Sustainable Development Goals (SDG) for TB elimination by 2030.
• Existing screening methods have limitations in addressing the need for widespread TB detection.

Purpose of the Study:

• To evaluate the diagnostic accuracy of a novel point-of-care breath analyzer for tuberculosis detection.
• To assess the potential of detecting volatile organic compounds in exhaled breath as a TB screening tool.
• To compare the performance of the breath analyzer against the WHO-recommended TrueNat assay.

Main Methods:

• A single-center pilot study was conducted involving 334 participants presenting with TB signs or symptoms.
• The Tuberculosis Breath Analyzer, detecting volatile organic compounds in exhaled breath, was used as the testing device.
• The TrueNat assay served as the reference standard for diagnosing Mycobacterium tuberculosis infection.

Main Results:

• The Tuberculosis Breath Analyzer demonstrated a sensitivity of 95.7% and a specificity of 91.3%.
• The receiver operating characteristic (ROC) area was calculated to be 0.935, indicating high diagnostic performance.
• The breath analyzer's efficiency was found to be comparable to the TrueNat assay.

Conclusions:

• The point-of-care Tuberculosis Breath Analyzer exhibits high sensitivity and specificity, making it a reliable diagnostic tool.
• This breath analysis technology shows potential as an effective screening method for tuberculosis.
• Further large-scale, multicenter studies are recommended to validate these promising findings and expand their applicability.