A comprehensive clinical trial conducted at the Jiangsu Center for Disease Control and Prevention has evaluated a novel ESAT6-CFP10 (EC) skin test for tuberculosis screening, offering potential improvements over traditional diagnostic methods.
Study Design and Population Characteristics
The investigation was structured as a randomized, double-blind, parallel-controlled trial, enrolling healthy adults aged 18-65 years. The study proceeded in two distinct phases, with the first stage focusing on comparing three diagnostic methods: the T-SPOT blood test, traditional tuberculin skin test (TB-PPD), and the novel EC skin test.
Innovative Testing Approach
The EC skin test, developed by Anhui Zhifei Longcom Biopharmaceutical Co., was administered alongside the conventional TB-PPD test, with careful attention to standardization and safety monitoring. Participants received the TB-PPD test on their left forearm and the EC test on their right forearm, with mandatory 30-minute observation periods to monitor for adverse reactions.
BCG Vaccination Impact Assessment
In a notable second phase, the study examined the influence of BCG vaccination on test results. Participants who tested negative on all three initial screening methods were randomly assigned to receive either BCG vaccination or placebo in a 2:1 ratio. Follow-up testing occurred 12 weeks post-vaccination to evaluate any potential interference with test accuracy.
Rigorous Methodology and Safety Protocols
The trial maintained high scientific standards through:
- Strict randomization and masking procedures
- Independent blind observers for result verification
- Comprehensive safety monitoring
- Standardized measurement of skin reactions at 24 and 48 hours
Statistical Considerations
The study design targeted a substantial sample size of approximately 1,500 healthy participants, accounting for an anticipated 20% dropout rate and an expected 23% tri-negative rate based on previous phase 2b trial data. Statistical analysis employed sophisticated methods including Cohen's k for concordance calculations and multivariate logistic regression modeling.
Clinical Implications
This research represents a significant step forward in TB diagnostics, potentially offering healthcare providers a more accurate screening tool. The inclusion of BCG vaccination impact assessment is particularly relevant for countries with widespread BCG vaccination programs, addressing a crucial practical consideration in TB screening protocols.
