WHO operational guidelines on tuberculosis: module 3: diagnosis: rapid diagnostics for tuberculosis detection: web annex B: GRADE profiles

This web annex to the third edition of the WHO consolidated guidelines on tuberculosis, Module 3: diagnosis, presents Grading of Recommendations Assessment, Development and Evaluation (GRADE) profiles for rapid diagnostic technologies used in tuberculosis detection and drug-resistance testing. The document supports the evidence-to-decision process underlying WHO recommendations by summarizing the certainty of evidence, diagnostic accuracy and clinical impact of multiple assays across different populations and specimen types.

The publication compiles evidence profiles for Xpert MTB/RIF, Xpert Ultra, Truenat assays, line probe assays, low- and moderate-complexity nucleic acid amplification tests, lateral flow urine lipoarabinomannan assays and targeted next-generation sequencing. It includes analyses of sensitivity, specificity, patient-important outcomes and methodological considerations such as risk of bias, indirectness, inconsistency and imprecision. The annex covers diagnostic applications for pulmonary and extrapulmonary tuberculosis in adults and children, including tuberculosis meningitis and lymph node tuberculosis. The document is intended to provide transparency regarding the evidence base used in developing WHO policy recommendations on rapid diagnostics for tuberculosis detection and drug-resistance assessment.