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Randomised Clinical Trial Investigating the Specificity of a Novel Skin Test (C-Tb) for Diagnosis of M. tuberculosis Infection

Aggerbeck, H, Tingskov, PN, Joshi, P, Boyle, J, Lewis, DJM, Giemza, R, Hoff, ST and Andersen, P (2013) Randomised Clinical Trial Investigating the Specificity of a Novel Skin Test (C-Tb) for Diagnosis of M. tuberculosis Infection PLoS ONE, 8 (5).

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Abstract

Background:Tuberculin skin testing is simple and relatively inexpensive, but the specificity of PPD is affected by BCG vaccination.Objective:Determine optimal dose and specificity of recombinant ESAT-6 and CFP-10 (C-Tb) produced in Lactococcus lactis for diagnosis of M. tuberculosis infection.Methods:In a dose finding phase I trial 0.01 or 0.1 μg preserved and unpreserved C-Tb was injected by Mantoux technique in 38 patients with active tuberculosis and induration responses measured. In a phase II specificity trial in 151 uninfected, BCG vaccinated participants 0.1 μg C-Tb was compared to 2 TU PPD.Results:0.1 μg C-Tb gave a median induration of 15 mm after 2 days. Phenol preservation did not affect the response. The specificity of C-Tb was 99.3% (95% CI 96-100%) regarding indurations ≥5 mm as a positive outcome. This was higher than the specificity of PPD (63% using a cut-off of 5 mm or 92% using a cut-off of 15 mm to adjust for non-specific BCG responses). Local adverse reactions following C-Tb injection included transient itching and discomfort as expected components of the immune response.Conclusion:C-Tb offers a simple and convenient skin test to diagnose M. tuberculosis infection using a single, universal cut-off unaffected by BCG vaccination. Trial Registration: ClinicalTrials.gov NCT01033929 and NCT01241188. © 2013 Aggerbeck et al.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > Surrey Clinical Research Centre
Authors :
AuthorsEmailORCID
Aggerbeck, HUNSPECIFIEDUNSPECIFIED
Tingskov, PNUNSPECIFIEDUNSPECIFIED
Joshi, PUNSPECIFIEDUNSPECIFIED
Boyle, JUNSPECIFIEDUNSPECIFIED
Lewis, DJMUNSPECIFIEDUNSPECIFIED
Giemza, RUNSPECIFIEDUNSPECIFIED
Hoff, STUNSPECIFIEDUNSPECIFIED
Andersen, PUNSPECIFIEDUNSPECIFIED
Date : 14 May 2013
Identification Number : 10.1371/journal.pone.0064215
Additional Information : Copyright: 2013 Aggerbeck et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Depositing User : Symplectic Elements
Date Deposited : 18 Aug 2015 15:34
Last Modified : 18 Aug 2015 15:34
URI: http://epubs.surrey.ac.uk/id/eprint/808247

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