Indication - Tuberculosis (TB)
M. tuberculosis DNA mutations associated with resistance
Facility level:
Assay formats
Molecular line probe assay (LPA)
Status history
First added in 2018
Changed in 2020
Purpose type
To detect resistance to second-line anti-TB medicines
Specimen types
WHO prequalified or recommended products
The use of molecular line probe assays for the detection of resistance to second-line anti-tuberculosis drugs: policy update (2016) http://apps.who.int/iris/handle/10665/246131
WHO supporting documents
Compendium of WHO guidelines and associated standards: ensuring optimum delivery of the cascade of care for patients with tuberculosis (2017) https://www.who.int/tb/publications/Compendium_WHO_guidelines_TB_2017/en/ Implementing tuberculosis diagnostics: policy framework (2015) https://apps.who.int/iris/handle/10665/162712
ICD11 code: 1B1Z

Summary of SAGE IVD recommendation

General In vitro diagnostics tests are the general core and routine laboratory tests for clinical chemistry, haematology, blood transfusion, microbiology (virology, bacteriology, parasitology and mycology) and histopathology. These tests were selected on the basis of the scientific validity of an analyte, i.e. the association between an analyte and a clinical condition or physiological state; and clinical utility. Many of these tests are required for effective management of patients and have already been described in WHO publications.

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.