• Eur. J. Clin. Microbiol. Infect. Dis. · Mar 2019

    Evaluation of Xpert MTB/RIF Ultra performance for pulmonary tuberculosis diagnosis on smear-negative respiratory samples in a French centre.

    • Elisabeth Hodille, Audey Maisson, Laurine Charlet, Clyde Bauduin, Charlotte Genestet, Isabelle Fredenucci, Jean-Philippe Rasigade, Gérard Lina, and Oana Dumitrescu.
    • Hospices Civils de Lyon, Hôpital de la Croix Rousse-Centre de Biologie Nord, Institut des Agents Infectieux, Laboratoire de Bactériologie, Grande Rue de la Croix Rousse, 69004, Lyon, France. elisabeth.hodille@chu-lyon.fr.
    • Eur. J. Clin. Microbiol. Infect. Dis. 2019 Mar 1; 38 (3): 601-605.

    AbstractTuberculosis (TB) is a worldwide public health concern, including in high-resource countries with a low prevalence of TB. Xpert MTB/RIF assay was developed to improve TB and rifampicin (RIF) resistance detection, but sensitivity remains poor on smear-negative sputum. Xpert MTB/RIF Ultra assay was designed to enhance the sensitivity of TB detection in clinical samples. Herein, we evaluated retrospectively the performance of this test on smear-negative respiratory samples. Respiratory specimens with smear-negative and a Mycobacterium tuberculosis (MTB) complex-positive culture were retrospectively selected from those taken from patients during routine care, and analysed in the Mycobacteria Laboratory of the Lyon University hospital, France. Specimens were stored at - 20 °C before testing by Xpert MTB/RIF Ultra. For each sample, growth delay and date of anti-TB treatment initiation were recorded. Forty-six samples-29 sputum, 8 bronchial aspirates, 6 broncho-alveolar lavages, and 3 gastric aspirates-were selected. Among samples collected before treatment initiation (n = 33), sensitivity was 81.8% (95% CI [64.5; 93.0]) and there was a significant correlation between the quantitative measurements (Ct) of Xpert MTB/RIF Ultra assay and the time to growth detection in culture. Among samples collected after treatment initiation (n = 12), sensitivity was 100%, without correlation with time to growth detection due to presence of afterglow DNA in samples. In high-resource settings, the Xpert MTB/RIF Ultra test represents a useful tool for pulmonary TB diagnosis, notably for the paucibacillary forms. Moreover, quantitative measurement of Xpert MTB/RIF Ultra could help to predict time to MTB culture positivity and be used as a quality indicator of MTB culture process.

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