PLoS ONE (Jan 2022)

Diagnostic performance of the AID line probe assay in the detection of Mycobacterium tuberculosis and drug resistance in Romanian patients with presumed TB.

  • Andrea Rachow,
  • Elmar Saathoff,
  • Roxana Mindru,
  • Oana Popescu,
  • Doinita Lugoji,
  • Beatrice Mahler,
  • Matthias Merker,
  • Stefan Niemann,
  • Ioana D Olaru,
  • Sabine Kastner,
  • Michael Hoelscher,
  • Christoph Lange,
  • Elmira Ibraim

DOI
https://doi.org/10.1371/journal.pone.0271297
Journal volume & issue
Vol. 17, no. 8
p. e0271297

Abstract

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BackgroundThe AID line probe assay has shown promising evaluation data on the detection of Mycobacterium tuberculosis as well as 1st- and 2nd-line drug resistance, using isolates and selected clinical samples in previous studies.MethodsThe diagnostic performance of three AID-modules (AID INH/RIF, AID FQ/EMB and AID AG) was analyzed in sputum samples from patients with presumed tuberculosis against culture methods and phenotypic drug resistance as reference standards.Results59 patients had culture-confirmed tuberculosis. All AID modules showed moderate sensitivity (46/59, 78.0%, 65.3-87.7) and very good specificity (100%, 95.5%, 93.7%). There was a high proportion of invalid tests, resulting in 32.6%, 78.3% and 19.6% of 46 AID-positive tuberculosis cases, who could not be assessed for drug resistance by the AID INH/RIF-, AID FQ/EM- and AID AG-module, respectively. A small number of patients showed drug resistance by reference standards: Three MDR-TB cases plus three, one and one patients with resistance to streptomycin, fluoroquinolones and aminoglycosides, respectively. The AID-assay detected all MDR-TB cases, two of three streptomycin-resistant TB cases, one of one of fluoroquinolone-resistant and missed one aminoglycoside-resistant TB case.DiscussionThe high proportion of invalid results precludes the use of the AID-assay from direct sputum-based tuberculosis and drug-resistance testing.