Indication - Tuberculosis (TB)
Drug susceptibility testing of M. tuberculosis culture
Facility level:
Assay formats
Drug susceptibility testing
Status history
First added in 2018
Changed in 2020
Purpose type
To detect resistance to first-line and/or second-line anti-TB medicines
Specimen types
Bacterial culture of M. tuberculosis
WHO prequalified or recommended products
Technical report on critical concentrations for drug susceptibility testing of medicines used in the treatment of drug-resistant tuberculosis (2018) http://apps.who.int/iris/bitstream/10665/260470/1/WHO-CDS-TB-2018.5-eng.pdf?ua=1
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.