Journal
CLINICAL INFECTIOUS DISEASES
Volume 54, Issue 3, Pages 384-388Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/cir824
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Funding
- European Commission
- Foundation for Innovative New Diagnostics
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- South African National Research Foundation (SA NRF)
- McGill University Health Centre Research Institute and Shastri Indo-Canadian Institute
- Discovery Foundation
- Centre National Institutes of Health [R24TW007988]
- SATBAT
- EDCTP
- EDCTP (TB-NEAT, Trials of Excellence in Southern Africa (TESA)
- South African Department of Science and Technology (SA DST)
- SA NRF (SARChI)
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Xpert MTB/RIF-generated cycle-threshold (C-T) values have poor clinical utility as a rule-in test for smear positivity (cut-point <= 20.2; sensitivity 32.3%, specificity 97.1%) but moderately good rule-out value (cut-point >31.8; negative predictive value 80.0%). Thus, 20% of individuals with C-T values >31.8 were erroneously ruled out as smear-negative. This group had a significantly lower sputum bacillary load relative to correctly classified smear-positive patients (C-T <= 31.8; P < .001). These data inform on public health and contact tracing strategies.
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