Systematic Review and Meta-Analysis of Urine-Based Molecular Testing for Urogenital Tuberculosis.

Abstract

Background: Early confirmation of urogenital tuberculosis (UGTB) remains challenging in routine practice because conventional culture is slow and has variable sensitivity. Urine-based molecular testing has emerged as a rapid alternative, but its performance estimates vary across studies. This systematic review evaluated the diagnostic value of urine-based molecular testing, including Xpert Mycobacterium tuberculosis/rifampicin, multiplex polymerase chain reaction and loop-mediated isothermal amplification, for UGTB.

Methods: Risk of bias was assessed using Quality Assessment of Diagnostic Accuracy Studies-2. Pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio (DOR) were generated with a bivariate random-effects model. The summary receiver operating characteristic (SROC) curve and Fagan nomogram were used for visualization.

Results: A total of 14 diagnostic accuracy studies, comprising 1697 patients with high clinical suspicion of UGTB, were analysed. Pooled sensitivity was 0.748 (95% confidence interval [CI]: 0.566-0.871), pooled specificity was 0.962 (95% CI: 0.932-0.979), pooled DOR was 121.77 (95% CI: 37.86-391.68), and the area under the SROC curve was 0.93. Studies using bacterial culture as the reference standard yielded a pooled specificity of 1.000, whereas those using a composite reference standard yielded a pooled specificity of 0.934. With a 20% pre-test probability, a positive test increased the post-test probability to 83%, while a negative test lowered it to 6%.

Conclusions: Urine-based molecular testing shows high diagnostic accuracy and clinical utility for UGTB. It may serve as an adjunctive test for early rapid confirmation, especially when interpreted alongside clinical, imaging and culture findings. The PROSPERO Registration: The study was registered on https://www.crd.york.ac.uk/prospero/ (registration number: CRD420261373256; registration link: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261373256).