Near point-of-care nucleic acid amplification tests (NPOC-NAATs) using respiratory specimens for detection of pulmonary tuberculosis

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.