Background
Programmes that introduce rapid molecular tests for tuberculosis and tuberculosis drug resistance aim to bring tests closer to the community, and thereby cut delay in diagnosis, ensure early treatment, and improve health outcomes, as well as overcome problems with poor laboratory infrastructure and inadequately trained personnel. Yet, diagnostic technologies only have an impact if they are put to use in a correct and timely manner. Views of the intended beneficiaries are important in uptake of diagnostics, and their effective use also depends on those implementing testing programmes, including providers, laboratory professionals, and staff in health ministries. Otherwise, there is a risk these technologies will not fit their intended use and setting, cannot be made to work and scale up, and are not used by, or not accessible to, those in need.
Objectives
To synthesize end‐user and professional user perspectives and experiences with low‐complexity nucleic acid amplification tests (NAATs) for detection of tuberculosis and tuberculosis drug resistance; and to identify implications for effective implementation and health equity.
Search methods
We searched MEDLINE, Embase, CINAHL, PsycInfo and Science Citation Index Expanded databases for eligible studies from 1 January 2007 up to 20 October 2021. We limited all searches to 2007 onward because the development of Xpert MTB/RIF, the first rapid molecular test in this review, was completed in 2009.
Selection criteria
We included studies that used qualitative methods for data collection and analysis, and were focused on perspectives and experiences of users and potential users of low‐complexity NAATs to diagnose tuberculosis and drug‐resistant tuberculosis. NAATs included Xpert MTB/RIF, Xpert MTB/RIF Ultra, Xpert MTB/XDR, and the Truenat assays. Users were people with presumptive or confirmed tuberculosis and drug‐resistant tuberculosis (including multidrug‐resistant (MDR‐TB)) and their caregivers, healthcare providers, laboratory technicians and managers, and programme officers and staff; and were from any type of health facility and setting globally. MDR‐TB is tuberculosis caused by resistance to at least rifampicin and isoniazid, the two most effective first‐line drugs used to treat tuberculosis.
Data collection and analysis
We used a thematic analysis approach for data extraction and synthesis, and assessed confidence in the findings using GRADE CERQual approach. We developed a conceptual framework to illustrate how the findings relate.
Main results
We found 32 studies. All studies were conducted in low‐ and middle‐income countries. Twenty‐seven studies were conducted in high‐tuberculosis burden countries and 21 studies in high‐MDR‐TB burden countries. Only one study was from an Eastern European country. While the studies covered a diverse use of low‐complexity NAATs, in only a m...