Guideline Development Group meeting “Nucleic acid amplification tests to detect TB and DR-TB”

7 – 18 December 2020

7-18 December 2020

Tuberculosis (TB) causes 10 million cases and 1.5 million deaths annually and it is estimated that 3 million cases go undiagnosed each year[1]. Drug-resistant TB (DR-TB) is a major threat to global TB control. Ending the global TB epidemic will be achievable over the next 20 years only if there is intensive action by all countries which have endorsed the End TB Strategy and its ambitious targets[2]. Early diagnosis and prompt treatment of all persons of all ages with any form of drug-susceptible or drug-resistant TB is fundamental. WHO-endorsed rapid TB diagnostics and drug susceptibility testing (DST) should be available to all persons with signs and symptoms of TB to meet the targets of the End TB Strategy.

Three classes of technologies are considered for this meeting:

  • End-to-End (E2E) solutions for detection of tuberculosis, rifampicin and isoniazid resistance
  • Cartridge based nucleic acid amplification tests (CB-NAT) assay for detection of isoniazid resistance and second line medicines
  • Hybridization-based line probe assay for detection pyrazinamide resistance (PZA LPA)

 

Objectives

  • To assess the available data on the diagnostic accuracy (sensitivity and specificity) of three classes of technologies (E2E solutions, CB-NAT assay, PZA LPA) for diagnosis of active pulmonary TB (PTB) and detection of drug resistance in adults and children with signs and symptoms of TB.
  • To assess the available data related to the impact of these three technologies (E2E solutions, CB-NAT assay, PZA LPA) on patient important outcomes, including cure, mortality, time to diagnosis and time to treatment initiation.
  • To conduct a review of the published qualitative data on feasibility, accessibility, equity and end-user values related to E2E solutions, CB-NAT assay and PZA LPA implementation.
  • To conduct a review of the published economic data on affordability, cost, and cost-effectiveness of E2E solutions, CB-NAT assay and PZA LPA implementation to assist in the diagnosis of TB and detection of resistance to anti-TB drugs.
  • To determine questions for future research and issues to be addressed by WHO in subsequent policy recommendations.


WHO will convene a Guideline Development Group (GDG) 7-18 December 2020 in accordance with the WHO processes and procedures for guideline development, to assess the available evidence on the use of afore-mentioned technologies which will be later disseminated as the WHO guidelines.