Impact of rapid nucleic acid amplification tests for tuberculosis on patient outcomes
Abstract
Rationale: The World Health Organization (WHO) recommends rapid nucleic acid amplification tests (NAATs), such as Xpert MTB/RIF Ultra, as the initial diagnostic test for tuberculosis (TB). However, the effect of these tests on key health outcomes is not well-established.
Objectives: To assess the effects of three classes of rapid NAATs-low-complexity automated (LC-aNAATs), low-complexity manual (LC-mNAATs) and moderate-complexity automated (MC-aNAATs)-compared with smear microscopy or bacterial culture on patient outcomes in people investigated for TB, irrespective of age or disease severity. Our secondary objective was to assess the effects of the three classes of rapid NAATs in vulnerable populations such as children and people living with HIV, to inform health equity considerations.
Search methods: We searched Cochrane CENTRAL, MEDLINE, Embase, five other electronic bibliographic databases, and two trial registries, from 1900 up to 21 January 2025. We also checked reference lists of included articles and relevant systematic reviews to identify additional studies. We contacted manufacturers, researchers, and experts working on new diagnostic tests for TB through a WHO public call for data, which lasted from 30 November 2023 to 15 February 2024.
Eligibility criteria: We included randomised controlled trials (RCTs) that involved children and adults of any age who were suspected to have TB (i.e. 'presumptive TB'). We included both individually randomised and…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 11,228 participants or records.
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