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Low-complexity manual nucleic acid amplification tests for pulmonary tuberculosis in children

Inbaraj LR, Sathya Narayanan MK, Daniel J, Srinivasalu VA, Bhaskar A, Daniel BD, Epsibha T, Scandrett K et al.

The Cochrane database of systematic reviews, 2025

1,000 participants · 2 citations

Abstract

Background: Accurate and prompt diagnosis of tuberculosis in children is challenging due to non-specific clinical presentation and the low bacillary load of samples. Low-complexity manual nucleic acid amplification tests (LC-mNAATs) such as loop-mediated isothermal amplification (TB-LAMP) are World Health Organization (WHO)-recommended rapid molecular diagnostic tests. Even in resource-limited settings, they have good diagnostic accuracy in adults.

Objectives: To determine the diagnostic accuracy of LC-mNAATs for the detection of pulmonary tuberculosis in children (< 10 years) with presumptive pulmonary tuberculosis. Secondary objectives 1. To compare the diagnostic accuracy of LC-mNAATs and Xpert MTB/RIF Ultra for the detection of pulmonary tuberculosis in children with presumptive pulmonary tuberculosis. 2. To compare the diagnostic accuracy of LC-mNAATs and smear microscopy for detecting pulmonary tuberculosis in children when TB-LAMP is considered as a replacement test for smear microscopy. 3. To determine the diagnostic accuracy of LC-mNAATs for the detection of pulmonary tuberculosis if used as an add-on test amongst sputum smear-negative children. 4. To investigate potential sources of heterogeneity in the diagnostic accuracy of LC-mNAATs due to factors such as smear status, age, HIV status, setting, and tuberculosis burden.

Search methods: We searched CENTRAL, MEDLINE, Embase, Science Citation Index, Biosis Previews, Global Index Medicus, SCOPUS, WHO ICTRP, 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: 1,000 participants or records.

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