ESAT6-MPT64 Skin Test: Phase 1 Clinical Trial Safety and Diagnostic Performance

60 participants from a Phase 1 clinical trial evaluating a novel recombinant skin test for Mycobacterium tuberculosis infection. The dataset likely contains safety, tolerability, and diagnostic performance metrics, including sensitivity, specificity, and concordance with an interferon-γ release assay. Author Xichao Ou published the data under a CC-BY-4.0 license on figshare in April 2026.

Use Cases

• Compare diagnostic sensitivity and specificity of a new skin test based on the described ESAT6-MPT64 fusion protein.
• Analyze safety and tolerability profiles from dose-escalation cohorts based on adverse event data mentioned in the description.
• Assess concordance between skin test results and interferon-γ release assays based on the reported kappa statistic.
• Evaluate receiver operating characteristic (ROC) curves for diagnostic accuracy based on the reported area under the curve (AUC) values.

Strengths

• Data originates from a registered Phase 1 clinical trial (ChiCTR2500112887) with a defined protocol.
• Includes results from 60 participants, stratified into 30 healthy controls and 30 active tuberculosis patients.
• Reports specific performance metrics, including a peak sensitivity of 87.0% and specificity with a 13.3% non-specific reaction rate.
• Demonstrates substantial concordance with an established assay, with a kappa statistic reported as greater than 0.60.

Limitations

• Row count and column-level documentation are absent; field semantics must be inferred after download.
• The dataset is very small (20.7 KB), indicating limited scope, likely a summary table rather than raw participant-level data.
• Data may reflect the single-center design bias inherent to the described trial.

Provenance

Source

figshare, author Xichao Ou

Collection Method

Data collected during a single-center, randomized, open-label, dose-escalation Phase 1 clinical trial.

Freshness

Last updated 2026-04-21 05:20:10; freshness should be verified.