Retrospective Cohort Analysis for Identification of Discordant Rifampicin-resistant Xpert MTB/RIF Assay Results in South Kivu, Eastern Democratic Republic of the Congo, a High Burden Tuberculosis Setting.

Background The Xpert assay has revolutionized the rapid detection of resistance to rifampicin. However, Xpert has its pitfalls. We explored potential determinants of false-positive rifampicin resistance when using Xpert, aiming to refine the precision of tuberculosis diagnostics and subsequently con...

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Publicado en:Clinical Infectious Diseases Vol. 82; no. 2; pp. 274 - 282
Autores principales: Bisimwa, Bertin C, Kiselinova, Maja, Cuella-Martin, Isabel, Rigouts, Leen, Bulabula, André N H, Byela, Valéry, Chirambiza, Jean-Paul, Mulume, Eric, Birembano, Freddy, Katoto, Patrick D M C
Formato: research tables/charts Journal Article
Publicado: Oxford University Press / USA 2/15/2026
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Oxford University Press / USA
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        atl: Retrospective Cohort Analysis for Identification of Discordant Rifampicin-resistant Xpert MTB/RIF Assay Results in South Kivu, Eastern Democratic Republic of the Congo, a High Burden Tuberculosis Setting.
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        au:
          Bisimwa, Bertin C
          Kiselinova, Maja
          Cuella-Martin, Isabel
          Rigouts, Leen
          Bulabula, André N H
          Byela, Valéry
          Chirambiza, Jean-Paul
          Mulume, Eric
          Birembano, Freddy
          Katoto, Patrick D M C
        affil: Center for Tropical Diseases and Global Health, Faculty of Medicine, Catholic University of Bukavu, Bukavu, Democratic Republic of the CongoInstitut Supérieur des Techniques Médicales de Bukavu, Bukavu, Democratic Republic of the CongoMycobacteriology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, BelgiumFaculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
      sug:
        subj:
          Tuberculosis, Multidrug-Resistant Diagnosis
          Mycobacterium Tuberculosis
          Rifampin
          Drug Resistance, Microbial
          Molecular Diagnostic Techniques Methods
          Sensitivity and Specificity
          Human
          Male
          Female
          Adolescence
          Adult
          Middle Age
          Democratic Republic of the Congo
          Retrospective Design
          Record Review
          Prospective Studies
          Cross Sectional Studies
          Comparative Studies
          Descriptive Statistics
          Data Analysis Software
          Pearson's Correlation Coefficient
          Chi Square Test
          T-Tests
          Microscopy
          Logistic Regression
          Nucleic Acids
          Implementation Science
          Polymerase Chain Reaction
          DNA
          Genetics
          In Situ Hybridization, Fluorescence
          Funding Source
          Adolescent: 13-18 years
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Male
          Female
      ab: Background The Xpert assay has revolutionized the rapid detection of resistance to rifampicin. However, Xpert has its pitfalls. We explored potential determinants of false-positive rifampicin resistance when using Xpert, aiming to refine the precision of tuberculosis diagnostics and subsequently contribute to better patient outcomes. Methods This is a retrospective cross-sectional analysis of archived Xpert files from the South Kivu province, used to diagnose Mycobacterium tuberculosis (MTB) between 2013 and 2018. Xpert cycle threshold was extracted for each molecular beacon probe, and Δ Ct was calculated. We used the MTBDR plus line-probe assay, which covers the same 81-bp RRDR, as a reference test. Results Of 1900 samples positive for MTB, 220 (11.2%) were rifampicin resistant. Of the 141 patients' sputum samples that had results for both Xpert and MTBDR plus , 45 (31.9%) showed discordant results with Xpert, indicating rifampicin resistance while MTBDR plus indicated rifampicin susceptibility, suggesting false-positive rifampicin resistance detection by Xpert, predominantly in samples with very low (Ct > 28, odds ratio [OR] = 2.23, 95% CI: 1.30–3.82) or low (Ct 22–28, OR = 1.81, 95% CI: 1.21–2.71) bacterial loads. Probe E was the most frequently missed probe, followed by multiple probe dropouts or absence of probe binding (OR = 1.5, 95% CI:.731–3.076). Conclusions Our findings indicate that low and very low MTB bacterial loads in sputum are strongly associated with discordant rifampicin resistance results when using Xpert. Further research into underlying mechanisms is needed to establish causality definitively.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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