C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV infected adults : a phase 3 trial
dc.contributor.author | Aggerbeck, Henrik | en_ZA |
dc.contributor.author | Ruhwald, Morten | en_ZA |
dc.contributor.author | Hoff, Soren T. | en_ZA |
dc.contributor.author | Borregaard, Bettine | en_ZA |
dc.contributor.author | Hellstrom, Elizabeth | en_ZA |
dc.contributor.author | Malahleha, Mookho | en_ZA |
dc.contributor.author | Siebert, Mirna | en_ZA |
dc.contributor.author | Gani, Mashra | en_ZA |
dc.contributor.author | Seopela, Vincent | en_ZA |
dc.contributor.author | Diacon, Andreas | en_ZA |
dc.contributor.author | Lourens, Madeleine | en_ZA |
dc.contributor.author | Andersen, Peter | en_ZA |
dc.contributor.author | Dheda, Keertan | en_ZA |
dc.date.accessioned | 2020-05-20T18:40:10Z | |
dc.date.available | 2020-05-20T18:40:10Z | |
dc.date.issued | 2018 | |
dc.description | CITATION: Aggerbeck, H., et al. 2018. C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIVinfected adults : a phase 3 trial. PLoS ONE, 13(9):e0204554, doi:10.1371/journal.pone.0204554. | |
dc.description | The original publication is available at https://journals.plos.org/plosone/ | |
dc.description.abstract | 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 <5 years (n = 87; HIV-uninfected), or symptomatic individuals of all ages presenting to clinics with suspected TB (n = 1003; 30% HIV-infected) were recruited from eight South African centres. C-Tb and TST were allocated to either forearm double blinded. Samples for QFT were collected in parallel, and test-positivity rates were compared. Results In participants with microbiologically confirmed TB (n = 75; 45% HIV-infected) sensitivity of C-Tb, TST and QFT were similar (72% versus 75% versus 73%; p>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. | en_ZA |
dc.description.uri | https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0204554 | |
dc.description.version | Publisher's version | |
dc.format.extent | 16 pages ; illustrations | |
dc.identifier.citation | Aggerbeck, H., et al. 2018. C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIVinfected adults : a phase 3 trial. PLoS ONE, 13(9):e0204554, doi:10.1371/journal.pone.0204554 | |
dc.identifier.issn | 1932-6203 (online) | |
dc.identifier.other | doi:10.1371/journal.pone.0204554 | |
dc.identifier.uri | http://hdl.handle.net/10019.1/108583 | |
dc.language.iso | en_ZA | en_ZA |
dc.publisher | Public Library of Science | |
dc.rights.holder | Authors retain copyright | |
dc.subject | Mycobacterium tuberculosis -- Testing | en_ZA |
dc.subject | Mycobacterium tuberculosis -- Diagnosis | en_ZA |
dc.subject | HIV-positive persons | en_ZA |
dc.subject | Preschool children | en_ZA |
dc.subject | Clinical trials | en_ZA |
dc.title | C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV infected adults : a phase 3 trial | en_ZA |
dc.type | Article | en_ZA |