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Comparing Tuberculosis Diagnostic Yield in Smear/Culture and Xpert® MTB/RIF-Based Algorithms Using a Non-Randomised Stepped-Wedge Design
Open accessAbstract
SETTING: Primary health services in Cape Town, South Africa. STUDY AIM: To compare tuberculosis (TB) diagnostic yield in an existing smear/culture-based and a newly introduced Xpert® MTB/RIF-based algorithm. METHODS: 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. RESULTS: 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. CONCLUSION: 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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In Naidoo et al. 2016, practical, financial or logistic constraints prevented simultaneous introduction of Xpert-based algorithm to all facilities.
“Practical, financial or logistic constraints prevented simultaneous introduction of Xpert-based algorithm to all facilities”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [91]
The Discussion (Strengths and limitations; page unavailable) says stepped-wedge analysis is appropriate where practical, financial or logistic constraints prevent simultaneous introduction, and that health services scheduled this study’s Xpert rollout according to operational requirements. The Methods (Study design, population and timeframes; page unavailable) confirms that facilities adopted the algorithm at different times. The paper does not explicitly say those constraints prevented simultaneous introduction in this study. (LLM, conf=0.82)
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Metadata
- Authors
- Naidoo, P., Dunbar, R., Lombard, C., du Toit, E., Caldwell, J., Detjen, A., Squire, S. B., Enarson, D. A., & Beyers, N.
- Affiliations
- Stellenbosch University (ZA)
- South African Medical Research Council (ZA)
- City of Cape Town (ZA)
- International Union Against Tuberculosis and Lung Disease (FR)
- Liverpool School of Tropical Medicine (GB)
- Corresponding author
- Naidoo, Pren
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2016-03-01
- Volume
- 11
- Issue
- 3
- Pages
- e0150487
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC4773132
- OpenAlex
- W2289838397
- Cited by
- 23
- References
- 30
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 2 · 2022: 3 · 2021: 4 · 2020: 2 · 2019: 2 · 2018: 3 · 2017: 3 · 2016: 1
- FWCI
- 2.77
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSTM Online Archive (Liverpool School of Tropical Medicine) (acceptedVersion)
- SUNScholar (Stellenbosch University) (submittedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- United States Agency for International Development (GHN-A-00-08-00004-00, GHN‐A‐00‐08‐00004)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Health Sciences › Medicine › Infectious Diseases › Infectious Diseases and Tuberculosis
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- tuberculosis, Xpert MTB/RIF, smear-negative tuberculosis, diagnostic yield, multidrug-resistant tuberculosis, primary care, people living with HIV, tuberculosis screening, stepped wedge design, Cape Town
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Algorithms, Child, Child, Preschool, Female, Humans, Infant, Male, Middle Aged, Sensitivity and Specificity, South Africa, Sputum, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Clinical Laboratory Techniques, Young Adult
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