Diagnostic Accuracy of Nucleic Acid Amplification Tests in Urine for Pulmonary Tuberculosis: A Meta-Analysis

Abstract

<bold>Objective:</bold> To determine the diagnostic accuracy of tuberculosis nucleic acid amplification tests (NAATs) in urine samples for active pulmonary tuberculosis (PTB). <bold>Design:</bold> Systematic review and meta-analysis. Electronic databases and reference lists were searched without language, setting or time restriction. Eligible articles examined Mycobacterium tuberculosis NAATs in urine samples for PTB diagnosis in patients with sputum culture as the reference standard and reported sufficient data for separately calculating sensitivity and/or specificity. <bold>Results:</bold> Eight studies including 1,045 participants from 7 countries with a mean age ranging from 28 to 48 years were included. Polymerase chain reaction (PCR) was the only NAAT employed in all 8 studies with IS6110, cfp32 or rPOB as gene targets. The pooled sensitivity and specificity was 0.63 (95% CI 0.45, 0.78) and 0.98 (95% CI 0.97, 1) respectively with higher sensitivity in HIV positive patients 0.74 (95% CI 0.26, 0.96). A spot urine sample, retaining the supernatant during urine processing, and Cfp32 were significant factors on meta-regression for 100% specificity (p<0.001). <bold>Conclusions:</bold> Sensitivity of TB PCR in urine for active PTB diagnosis is relatively poor and specificity is high. Optimizing specimen handling, gene targets or PCR techniques may improve diagnostic accuracy.