Abstract
BackgroundA small proportion of false rifampicin resistant results have previously been reported using GeneXpert MTB/RIF version G4 on sputum samples; however, this has not been investigated for urine samples in HIV-associated tuberculosis (TB).ObjectivesWe sought to determine the proportion of false rifampicin resistant results using Xpert MTB/RIF version G4 on urine samples among HIV-infected inpatients investigated for TB.MethodsHospitalised HIV-infected patients undergoing systematic TB testing from two cohorts in Cape Town, South Africa, were enrolled. All patients with ≥1 urine Xpert result available were included. Rifampicin resistant urine Xpert results were classified into three mutually exclusive groups: (1) true rifampicin resistance, (2) false rifampicin resistance or (3) unknown after review of available microbiologic and clinical data.ResultsOverall, 1171 patients were included, from whom a total of 1704 urine Xpert results were available on unconcentrated and/or concentrated urine samples. There were 416 samples positive for TB (24.4% [95% CI 22.4–26.5]), of which 43/413 (10.4% [95% CI 7.6–13.8]) were rifampicin resistant (after excluding three results that were falsely positive due to contamination). Of 43 rifampicin resistant Xpert results (among 40 patients), 30 were classified as true resistance, 11 as false resistance and 2 could not be classified. Excluding unclassifiable results, 30/41 results were confirmed as true-positive urine Xpert rifampicin resistance (positive predictive value: 73.2% [95% CI 57.1–85.8]).ConclusionUrine Xpert testing showed a high proportion of false rifampicin resistance results. Urine Xpert rifampicin resistant results should be interpreted cautiously and confirmed when possible.
Highlights
Tuberculosis (TB) remains the leading cause of death in people living with HIV, contributing to one-in-three AIDS-related deaths.[1]
Overall 1704 urine Xpert results were available from 1171 patients, of which 554 were performed on unprocessed urine samples and 1150 on concentrated urine samples (Figure 1)
Among 1704 urine Xpert results, there were 416 (24.4% [95% CI 22.4–26.5]) samples that tested positive for Mycobacterium tuberculosis (MTB) and 46 results indicating rifampicin resistance among 42 patients (Figure 1)
Summary
Tuberculosis (TB) remains the leading cause of death in people living with HIV, contributing to one-in-three AIDS-related deaths.[1]. Xpert rapidly detects rifampicin resistance, without need for an additional sample or cartridges. It has been endorsed by the World Health Organization (WHO) since 2010. Sputum Xpert (or Xpert Ultra where available) is currently recommended by the WHO as the initial diagnostic test in patients with suspected HIV-associated TB or multi-drug resistant (MDR) TB.[5] In those with microbiologically confirmed TB, Xpert MTB/RIF is recommended by the WHO as a first-line assay for the rapid detection of rifampicin-resistance. A small proportion of false rifampicin resistant results have previously been reported using GeneXpert MTB/RIF version G4 on sputum samples; this has not been investigated for urine samples in HIV-associated tuberculosis (TB)
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