Accuracy of ESAT6-CFP10 skin test compared with tuberculin skin test in a healthy population: a randomized, blind, parallel controlled phase III clinical study.

ABSTRACT:

Background

This study aimed to evaluate the diagnostic performance of ESAT6-CFP10 (EC) skin test in healthy population and determine the factors influencing the booster effect.

Methods

We conducted a randomized, double-blind, parallel controlled trial in healthy population. The experiment was divided into two stages. In the first stage, all participants underwent T-SPOT, TB-PPD, and EC tests. In the second stage, to evaluate whether BCG vaccination affected the efficacy of skin tests, the participants with three negative results in the first stage were randomly assigned to the BCG and placebo groups at a ratio of 2:1 and underwent three tests. The positivity rates and concordance of the three tests were calculated in both stages, and a logistic regression model was construct

SUBMITTER: Ding X 

PROVIDER: S-EPMC11684250 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature