title: Diagnostic performance of the Xpert MTB/RIF assay for tuberculous lymphadenitis on fine needle aspirates from Ethiopia.
abstract: The Xpert MTB/RIF (Xpert) test is a novel automated molecular diagnostic recently endorsed by the World Health Organization for rapid diagnosis of tuberculosis (TB). Nevertheless, performance related data from high TB prevalence regions to investigate clinically suspected TB lymphadenitis are limited. To evaluate the performance of Xpert test for direct detection of the Mycobacterium tuberculosis complex (MTBC) and rifampicin (RIF) resistance in lymph node aspirates, a cross-sectional study was conducted at four main hospitals in northern Ethiopia. Culture served as a reference standard for growth of MTBC and phenotypic and MTBDRplus drug susceptibility testing for detecting RIF resistance. Two-hundred-thirty-one fine needle aspirate (FNAs) specimens were processed simultaneously for smear, culture, and Xpert test. When compared to culture, the Xpert test correctly identified 29 out of 32 culture positive cases, 5 out of 11 contaminated cases, and 56 out of 188 culture negative cases. The overall sensitivity of the test was 93.5% [95% CI, 78.3-98.9%] and specificity 69.2% [95% CI, 66.4-70.0%]. The Xpert test identified the rpoB mutations associated with RIF resistance concordant with GenoType MTBDRplus and phenotypic drug susceptibility testing. In conclusion, the Xpert assay was found to perform well in detecting MTBC and RIF resistance in TB lymphadenitis patients. Furthermore, the test is simple and suitable to use in remote and rural areas for the diagnosis of TB lymphadenitis directly from FNAs in Ethiopia where TB/MDR-TB is rampant.
authors.affiliation: College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia; Institute of Medical Microbiology and Epidemiology of Infectious Diseases, University Hospital, University of Leipzig, Leipzig, Germany; Institute of Clinical Immunology, University Hospital, University of Leipzig, Leipzig, Germany; Translational Centre for Regenerative Medicine (TRM)-Leipzig, University of Leipzig, Leipzig, Germany. Electronic address: fantahun.degeneh@gmail.com.
authors.forename: Fantahun
authors.initials: F
authors.lastname: Biadglegne
authors.affiliation: College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia; Institute of Medical Virology, University Hospital, University of Leipzig, Leipzig, Germany.
authors.forename: Andargachew
authors.initials: A
authors.lastname: Mulu
authors.affiliation: Institute of Medical Microbiology and Epidemiology of Infectious Diseases, University Hospital, University of Leipzig, Leipzig, Germany.
authors.forename: Arne C
authors.initials: AC
authors.lastname: Rodloff
authors.affiliation: Institute of Clinical Immunology, University Hospital, University of Leipzig, Leipzig, Germany; Translational Centre for Regenerative Medicine (TRM)-Leipzig, University of Leipzig, Leipzig, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Sack
mesh_terms: D000293:Adolescent; D000995:Antitubercular Agents / Q000627:therapeutic use; D001426:Bacterial Proteins / Q000235:genetics*; D044963:Biopsy, Fine-Needle; D002478:Cells, Cultured; D003430:Cross-Sectional Studies; D004252:DNA Mutational Analysis / Q000379:methods; D012321:DNA-Directed RNA Polymerases; D024881:Drug Resistance, Bacterial / Q000235:genetics*; D005002:Ethiopia / Q000453:epidemiology; D005260:Female; D005838:Genotype; D006801:Humans; D008198:Lymph Nodes / Q000382:microbiology*; D008297:Male; D008826:Microbial Sensitivity Tests; D009154:Mutation; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000235:genetics* / Q000302:isolation & purification; D010641:Phenotype; D011237:Predictive Value of Tests; D015995:Prevalence; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D012293:Rifampin / Q000627:therapeutic use; D014388:Tuberculosis, Lymph Node / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology / Q000382:microbiology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology / Q000382:microbiology
chemical_list: D000995:Antitubercular Agents; D001426:Bacterial Proteins; D011933:Reagent Kits, Diagnostic; C505805:rpoB protein, Mycobacterium tuberculosis; D012321:DNA-Directed RNA Polymerases; D012293:Rifampin
keywords: Fine needle aspirates; TB lymphadenitis; Xpert test