Theresa Pfurtscheller, Ana Tsutsunava, Nino Maghradze, Mariam Gujabidze, Nino Bablishvili, Seda Yerlikaya, Claudia M Denkinger, Nestani Tukvadze, Ankur Gupta-Wright
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引用次数: 0
Abstract
Background: Xpert MTB/XDR (Cepheid) is recommended by the World Health Organization for drug susceptibility testing in patients with tuberculosis, with potential for rapid detection of isoniazid and fluoroquinolone resistance. However, diagnostic accuracy and clinical utility in a programmatic setting are unknown.
Methods: We evaluated the accuracy and clinical utility of Xpert MTB/XDR in patients with rifampicin-resistant pulmonary tuberculosis during programmatic implementation in Georgia between July 2022 and August 2024, using phenotypic drug susceptibility testing (DST) as a reference standard.
Results: An overall 140 patients were tested with Xpert MTB/XDR and phenotypic DST, and 94.9% and 33.8% had isoniazid and fluoroquinolone resistance by phenotypic DST, respectively. Xpert MTB/XDR showed 99.2% sensitivity (95% CI, 95.5%-100%) and 100% specificity (95% CI, 54.1%-100%) for isoniazid resistance. Sensitivity and specificity for fluoroquinolone resistance were 88.4% (95% CI, 74.9%-96.1%) and 100% (95% CI, 95.6%-100%). When indeterminate/invalid Xpert MTB/XDR results were included, 17.4% (8/46) and 6.2% (8/129) of patients with phenotypic fluoroquinolone and isoniazid resistance were missed. Median turnaround time for Xpert MTB/XDR was 1 day (IQR, 1-3) and median time to treatment was 4 days (IQR, 1-7). Phenotypic DST results took a median 43 days (IQR, 29-63) longer than Xpert MTB/XDR results. Finally, 95% (115/121; 95% CI, 89.5%-98.2%) of patients had fluoroquinolones appropriately prescribed based on Xpert MTB/XDR results.
Conclusions: Programmatic data confirm the high accuracy of Xpert MTB/XDR, despite being below the World Health Organization target product profile targets for fluoroquinolones, with significantly faster time to results than phenotypic DST.
期刊介绍：
Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.
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