Comparing Tuberculosis Diagnostic Yield in Smear/Culture and Xpert® MTB/RIF-Based Algorithms Using a Non-Randomised Stepped-Wedge Design

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Naidoo, Pren ; Dunbar, Rory ; Lombard, Carl ; du Toit, Elizabeth ; Caldwell, Judy ; Detjen, Anne ; Squire, S. Bertel ; Enarson, Donald A. ; Beyers, Nulda (2016)
  • Publisher: Public Library of Science
  • Journal: PLoS ONE, volume 11, issue 3 (eissn: 1932-6203)
  • Related identifiers: doi: 10.1371/journal.pone.0150487, pmc: PMC4773132
  • Subject: Research Article | Diagnostic Medicine | Bacteria | Anatomy | Infectious Diseases | Geographical locations | South Africa | Sputum | Mycobacterium Tuberculosis | People and places | wf_200 | wf_220 | Light Microscopy | Tuberculosis Diagnosis and Management | Actinobacteria | Africa | Biology and Life Sciences | Tuberculosis | Research and Analysis Methods | Research Laboratories | Physiology | wc_503_5 | Tropical Diseases | Government Laboratories | Body Fluids | Fluorescence Microscopy | Mucus | Bacterial Diseases | Multi-Drug-Resistant Tuberculosis | Organisms | Microscopy | Medicine and Health Sciences | Research Facilities

Setting\ud Primary health services in Cape Town, South Africa.\ud \ud Study Aim\ud To compare tuberculosis (TB) diagnostic yield in an existing smear/culture-based and a newly introduced Xpert® MTB/RIF-based algorithm.\ud \ud Methods\ud TB diagnostic yield (the proportion of presumptive TB cases with a laboratory diagnosis of TB) was assessed using a non-randomised stepped-wedge design as sites transitioned to the Xpert® based algorithm. We identified the full sequence of sputum tests recorded in the electronic laboratory database for presumptive TB cases from 60 primary health sites during seven one-month time-points, six months apart. Differences in TB yield and temporal trends were estimated using a binomial regression model.\ud \ud Results\ud TB yield was 20.9% (95% CI 19.9% to 22.0%) in the smear/culture-based algorithm compared to 17.9% (95%CI 16.4% to 19.5%) in the Xpert® based algorithm. There was a decline in TB yield over time with a mean risk difference of -0.9% (95% CI -1.2% to -0.6%) (p<0.001) per time-point. When estimates were adjusted for the temporal trend, TB yield was 19.1% (95% CI 17.6% to 20.5%) in the smear/culture-based algorithm compared to 19.3% (95% CI 17.7% to 20.9%) in the Xpert® based algorithm with a risk difference of 0.3% (95% CI -1.8% to 2.3%) (p = 0.796). Culture tests were undertaken for 35.5% of smear-negative compared to 17.9% of Xpert® negative low MDR-TB risk cases and for 82.6% of smear-negative compared to 40.5% of Xpert® negative high MDR-TB risk cases in respective algorithms.\ud \ud Conclusion\ud Introduction of an Xpert® based algorithm did not produce the expected increase in TB diagnostic yield. Studies are required to assess whether improving adherence to the Xpert® negative algorithm for HIV-infected individuals will increase yield. In light of the high cost of Xpert®, a review of its role as a screening test for all presumptive TB cases may be warranted.
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