Indication - Tuberculosis (TB)
M. tuberculosis DNA
Facility level:
Assay formats
Status history
First added in 2018
Changed in 2020
Purpose type
To diagnose active TB and simultaneously or sequentially detect rifampicin resistance
Specimen types
Sputum Broncho-alveolar lavage (BAL) or extra-pulmonary TB specimen types
WHO prequalified or recommended products
WHO meeting report of a technical expert consultation: non-inferiority analysis of Xpert MTB/RIF Ultra compared to Xpert MTB/RIF (2017) http://apps.who.int/iris/handle/10665/254792 Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: policy update (2013) https://apps.who.int/iris/handle/10665/112472
WHO supporting documents
Compendium of WHO guidelines and associated standards: Ensuring optimum delivery of the cascade of care for patients with tuberculosis, second edtion (2018) https://apps.who.int/iris/handle/10665/272644 Implementing tuberculosis diagnostics: policy framework (2015) https://apps.who.int/iris/handle/10665/162712
ICD11 code: 1B1Z

Summary of SAGE IVD recommendation

The selection of the disease specific diagnostics tests for the EDL took into account the relevant priority diseases for the WHO such as HIV infection, tuberculosis, malaria, viral hepatitis B and C, syphilis and HPV infection. For these diseases there are WHO guidelines and technical reports, including recommendations for the appropriate IVDs. These documents are the result of significant evidence review and formed the basis for the inclusion of these IVDs in the EDL.

Details of submission from 2020

The inclusion of this entry was based on WHO guidelines and technical reports that include recommendations for the appropriate IVDs.