FeedbackModule 3: Rapid diagnostics for tuberculosis detection
Module 3: Rapid diagnostics for tuberculosis detection
Table of Content (Online Version) :
- Acknowledgements
- Abbreviations and acronyms
- 1. Introduction
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2. Diagnostic tests with WHO recommendations
- 2.1 Conventional diagnostic tests for the diagnosis of TB
- 2.2 Initial tests for diagnosis of TB with drug-resistance detection
- 2.3 Initial tests for diagnosis of TB without drug-resistance detection
- 2.4 Follow-on diagnostic tests for detection of additional drug resistance
- 2.5 Tests WHO recommends against using
- 2.6 Phenotypic and genotypic DST
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3. Implementing a new diagnostic test
- 3.1 Placement of diagnostic tests in the tiered laboratory network
- 3.2 Pretest probability and test accuracy considerations
- 3.3 Epidemiologic considerations
- 3.4 Multi-disease platform considerations
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3.5 Steps and processes for implementing a new diagnostic test
- 3.5.1 Area 1 – Policies, budgeting and planning
- 3.5.2 Area 2 – Regulatory issues
- 3.5.3 Area 3 – Equipment
- 3.5.4 Area 4 – Supply chain
- 3.5.5 Area 5 – Procedures
- 3.5.6 Area 6 – Digital data
- 3.5.7 Area 7 – Quality assurance, control and assessment
- 3.5.8 Area 8 – Recording and reporting
- 3.5.9 Area 9 – Human resource training and competency assessment
- 3.5.10 Area 10 – Monitoring and evaluation
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4. Model algorithms
- 4.1 Algorithm 1 – mWRD as the initial diagnostic test for TB
- 4.2 Algorithm 2 – LF-LAM testing to aid in the diagnosis of TB among PLHIV
- 4.3 Algorithm 3 – DST for second-line drugs for people with RR-TB or MDR-TB
- 4.4 Algorithm 4 – mWRD as the initial or follow-on test to detect Hr-TB
- 4.5 Illustrative algorithm combinations
- 6.References
- Annex 1. Budgetary considerations for implementing a new diagnostic test
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Annex 2: Information sheets on the newly recommended products
- A2.1 Information sheet: Practical considerations for implementation of the Abbott RealTime MTB and Abbott RealTime MTB RIF/INH tests
- A2.2 Information sheet: Practical considerations for implementation of the BD MAX MDR-TB test
- A2.3 Information sheet: Practical considerations for implementation of the Roche cobas MTB and cobas MTB-RIF/INH assays
- A2.4 Information sheet: Practical considerations for implementation of the Bruker-Hain Lifesciences FluoroType MTB and FluoroType MTBDR
- A2.5 Information sheet: Practical considerations for implementation of the Cepheid Xpert MTB/XDR test
- A2.6 Information sheet: Practical considerations for implementation of the Nipro Genoscholar PZA-TB II assay
- Annex 3. Implementation of next-generation sequencing technologies
- Annex 4. Conflict of interest assessment
- Annex 5. Additional resources
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Download PPTSuggested citation. WHO operational handbook on tuberculosis. Module 3: diagnosis – rapid diagnostics for tuberculosis detection, third edition. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.