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

dc.contributor.authorAggerbeck, Henriken_ZA
dc.contributor.authorRuhwald, Mortenen_ZA
dc.contributor.authorHoff, Soren T.en_ZA
dc.contributor.authorBorregaard, Bettineen_ZA
dc.contributor.authorHellstrom, Elizabethen_ZA
dc.contributor.authorMalahleha, Mookhoen_ZA
dc.contributor.authorSiebert, Mirnaen_ZA
dc.contributor.authorGani, Mashraen_ZA
dc.contributor.authorSeopela, Vincenten_ZA
dc.contributor.authorDiacon, Andreasen_ZA
dc.contributor.authorLourens, Madeleineen_ZA
dc.contributor.authorAndersen, Peteren_ZA
dc.contributor.authorDheda, Keertanen_ZA
dc.date.accessioned2020-05-20T18:40:10Z
dc.date.available2020-05-20T18:40:10Z
dc.date.issued2018
dc.descriptionCITATION: 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.descriptionThe original publication is available at https://journals.plos.org/plosone/
dc.description.abstractBackground 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.urihttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0204554
dc.description.versionPublisher's version
dc.format.extent16 pages ; illustrations
dc.identifier.citationAggerbeck, 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.issn1932-6203 (online)
dc.identifier.otherdoi:10.1371/journal.pone.0204554
dc.identifier.urihttp://hdl.handle.net/10019.1/108583
dc.language.isoen_ZAen_ZA
dc.publisherPublic Library of Science
dc.rights.holderAuthors retain copyright
dc.subjectMycobacterium tuberculosis -- Testingen_ZA
dc.subjectMycobacterium tuberculosis -- Diagnosisen_ZA
dc.subjectHIV-positive personsen_ZA
dc.subjectPreschool childrenen_ZA
dc.subjectClinical trialsen_ZA
dc.titleC-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV infected adults : a phase 3 trialen_ZA
dc.typeArticleen_ZA
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