Abstract / Summary
Near point-of-care nucleic acid amplification tests (NPOC-NAATs) are a new class of diagnostics that can be used for tuberculosis diagnosis. NPOC-NAATs are suitable for use in peripheral levels of healthcare systems as they are battery-operated instrument-based tests without special infrastructure requirements and can be performed by health care workers with basic technical skills. We evaluated the accuracy of NPOC-NAATs in diagnosing pulmonary tuberculosis using respiratory samples.
To assess the diagnostic accuracy of NPOC-NAATs for detecting pulmonary tuberculosis using respiratory samples from adults, adolescents, and children with presumptive tuberculosis based on signs or symptoms or a positive diagnostic screening result. Secondary objectives included: 1) to compare the diagnostic accuracy of NPOC-NAATs versus smear microscopy or low complexity, automated nucleic acid amplification tests (LC-aNAATs) for detecting pulmonary tuberculosis using respiratory samples from adults, adolescents, and children; 2) to investigate potential sources of heterogeneity such as smear status, Xpert MTB/RIF Ultra semi-quantitative category, HIV status, age groups, and history of tuberculosis; 3) to summarise the frequency of inconclusive (invalid, error, no result, and indeterminate) index test results.
We searched seven databases including CENTRAL, MEDLINE, and Embase, plus two trial registers (ClinicalTrials.gov and the WHO ICTRP) between 21 and 25 July 2025, without language restrictions. A World Health Organization (WHO) Public Call for ongoing and unpublished studies was made between 29 May and 15 July 2025. In consultation with the WHO, we searched for studies published since 2024 to reflect the development dates of relevant tests.
We included studies that provided data on the diagnostic accuracy of NPOC-NAATs that met our criteria using respiratory specimens in children (less than 10 years old), adolescents (aged 10 to 14 years), and adults (aged 15 years and older) with presumptive pulmonary tuberculosis. The reference standards were culture and a composite reference standard that included culture or the clinical decision to treat.
We assessed the risk of bias using the Quality Assessment of Studies of Diagnostic Accuracy - Revised (QUADAS-2) and QUADAS-C tools.
Working in pairs, we independently extracted data using a standardised form. We used a bivariate model for the meta-analyses to estimate summary sensitivities and specificities for pulmonary tuberculosis detection. We performed subgroup analyses by smear status and HIV status. We conducted head-to-head comparisons of the accuracy of NPOC-NAATs with those of LC-aNAATs and sputum smear microscopy.