There are several subgroups to be considered for this recommendation:

• The recommendation is based on evidence of diagnostic accuracy in respiratory samples ofadults with signs and symptoms of pulmonary TB.
• The recommendation applies to people living with HIV (studies included a varying proportionof such individuals); performance on smear-negative samples was reviewed but was onlyavailable for TB detection, not for rifampicin and isoniazid resistance, and data stratified byHIV status were not available.
• The recommendation applies to adolescents and children based on the generalization ofdata from adults; an increased rate of indeterminate results may be found with paucibacillaryTB disease in children.
• The review did not consider extrapolation of the finding for use in people with extrapulmonaryTB and testing on non-sputum samples because data on diagnostic accuracy of technologiesin the class for non-sputum samples were limited.

Implementation considerations Factors to consider when implementing moderate complexity automated NAATs for detection of TB and resistance to rifampicin and isoniazid are as follows:

• local epidemiological data on resistance prevalence should guide local testing algorithms, whereas pretest probability is important for the clinical interpretation of test results;
• the cost of a test varies depending on parameters such as the number of samples in a batch and the staff time required; therefore, a local costing exercise should be performed;
• low, moderate and high complexity tests have successive increase in technical competency needs (qualifications and skills) and staff time, which affects planning and budgeting;
• availability and timeliness of local support services and maintenance should be considered when selecting a provider;
• laboratory accreditation and compliance with a robust quality management system (including appropriate quality control) are essential for sustained service excellence and trust;
• training of both laboratory and clinical staff is needed to ensure effective delivery of services and clinical impact;
• use of connectivity solutions for communication of results is encouraged, to improve efficiency of service delivery and reduce time to treatment initiation;
• moderate complexity automated NAATs may already be used programmatically for other diseases – for example, severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), HIV and antimicrobial resistance (AMR) – which could potentially facilitate implementation of TB testing on shared platforms;
• implementation of moderate complexity automated NAATs requires laboratories with the required infrastructure, space and efficient sample referral systems;
• although these are automated tests, well-trained skilled staff are needed to set up assays and complete maintenance requirements; and
• implementation of these tests should be context specific; thus, it should take into account access issues, especially in remote areas, where less centralized WHO-recommended technologies may be more appropriate