PLoS ONE (Jan 2018)

C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial.

  • Henrik Aggerbeck,
  • Morten Ruhwald,
  • Søren T Hoff,
  • Bettine Borregaard,
  • Elizabeth Hellstrom,
  • Mookho Malahleha,
  • Mirna Siebert,
  • Mashra Gani,
  • Vincent Seopela,
  • Andreas Diacon,
  • Madeleine Lourens,
  • Peter Andersen,
  • Keertan Dheda

DOI
https://doi.org/10.1371/journal.pone.0204554
Journal volume & issue
Vol. 13, no. 9
p. e0204554

Abstract

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BACKGROUND:C-Tb, an ESAT-6/CFP-10-based skin test, has similar sensitivity for active TB compared to tuberculin skin test (TST) and QuantiFERON-TB-Gold-In-Tube (QFT). However, data are limited in children and HIV-infected persons. METHODS:Asymptomatic South African contacts 0.5). All 3 tests had similar positivity rates in HIV-infected participants with active TB, however, positivity rates were reduced when CD4 counts were <100 cells/μL. In participants where active TB was excluded (n = 920), C-Tb (41%), TST (43%), and QFT (44%) also had similar test-positivity rates. Among asymptomatic contacts aged below five, 32% (28/87) tested positive with C-Tb and 32% (28/87) with TST (concordance 89%). Overall, C-Tb and TST showed a similar safety profile. CONCLUSION:C-Tb was safe and showed similar test-positivity rates, compared to TST and QFT, in children and HIV-infected persons with active or latent M. tuberculosis infection. These data inform the utility of C-Tb in clinical practice. TRIAL REGISTRATION:ClinicalTrials.gov NCT01642888. EudraCT 2011-005078-40.