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New interferon-gamma assays show improved sensitivity for diagnosing active tuberculosis compared to traditional skin tests. The ELISpot(PLUS) assay, combined with tuberculin skin testing, aids in rapidly excluding tuberculosis infection.

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Area of Science:

  • Infectious Diseases
  • Immunology
  • Diagnostic Medicine

Background:

  • The diagnostic utility of novel T-cell-based blood tests for active tuberculosis remains under investigation.
  • Accurate and rapid diagnosis is crucial for effective tuberculosis management.

Purpose of the Study:

  • To compare the diagnostic performance of two interferon-gamma release assays (IGRAs) against tuberculin skin testing (TST) in adults with suspected active tuberculosis.
  • To evaluate the sensitivity and specificity of standard ELISpot and ELISpot(PLUS) assays, and TST.

Main Methods:

  • A prospective study involving 389 adults with moderate to high clinical suspicion of active tuberculosis was conducted in routine UK hospital settings.
  • Interferon-gamma release assays, including standard ELISpot and ELISpot(PLUS) (using Rv3879c antigen), and tuberculin skin testing were performed.
  • Sensitivity, specificity, predictive values, and likelihood ratios were calculated for each diagnostic method.

Main Results:

  • The ELISpot(PLUS) assay demonstrated higher sensitivity (89%) compared to standard ELISpot (85%) and TST (79-83%) for diagnosing active tuberculosis.
  • The ELISpot(PLUS) assay showed a statistically significant improvement in sensitivity over TST with a 15-mm cutoff (P=0.01).
  • Combining ELISpot(PLUS) with TST achieved 99% sensitivity, enabling rapid exclusion of active tuberculosis when both results were negative.

Conclusions:

  • The ELISpot(PLUS) assay offers superior sensitivity compared to the standard ELISpot assay for active tuberculosis diagnosis.
  • The combination of ELISpot(PLUS) and TST is a valuable tool for the rapid exclusion of active tuberculosis in patients with a moderate to high pretest probability.
  • Further research may be needed to address variations in TST interpretation and the inclusion of immunosuppressed populations.