Accuracy of ESAT6-CFP10 Skin Test Compared to Tuberculin Skin Test
Study Overview
This study evaluated how well the ESAT6-CFP10 (EC) skin test works in healthy individuals and what factors affect its effectiveness.
Methods
We conducted a randomized, double-blind trial with healthy participants. The study had two stages:
- In the first stage, all participants took T-SPOT, TB-PPD, and EC tests.
- In the second stage, those with negative results in the first stage were randomly assigned to receive either BCG vaccination or a placebo, and then retested.
We calculated the positivity rates and agreement between the tests and used a logistic regression model to identify factors affecting the EC test’s effectiveness.
Results
In the first stage, 1,564 participants were tested:
- Positivity rates: T-SPOT (18.89%), EC (10.37%), TB-PPD (53.96%).
- Agreement between EC and T-SPOT was 88.97%.
In the second stage, 585 participants were tested:
- BCG group positivity rates: T-SPOT (4.76%), EC (7.30%), TB-PPD (73.65%).
- Placebo group positivity rates: T-SPOT (6.88%), EC (11.88%), TB-PPD (39.38%).
Factors that enhanced the EC test’s effectiveness included being 60 years or older and having a positive T-SPOT retest. Adverse reactions were mostly mild and included pain and itching at the injection site.
Conclusions
The EC skin test performed similarly to the T-SPOT test in healthy individuals and was not affected by BCG vaccination. The likelihood of a positive EC test increased with age and previous positive T-SPOT results.
Clinical Trial Registration
NCT02795260 – Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65 (III-healthy), Registered on June 10, 2016.
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