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Rachow, Andrea; Saathoff, Elmar; Mindru, Roxana; Popescu, Oana; Lugoji, Doinita; Mahler, Beatrice D.; Merker, Matthias; Niemann, Stefan; Olaru, Ioana; Kastner, Sabine; Hoelscher, Michael; Lange, Christoph und Ibraim, Elmira (2022): Diagnostic performance of the AID line probe assay in the detection of Mycobacterium tuberculosis and drug resistance in Romanian patients with presumed TB.
In: PLOS One 17(8), e0271297

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Abstract

Background The AID line probe assay has shown promising evaluation data on the detection of Mycobacterium tuberculosis as well as 1(st)- and 2(nd)-line drug resistance, using isolates and selected clinical samples in previous studies. Methods The 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. Results 59 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. Discussion The high proportion of invalid results precludes the use of the AID-assay from direct sputum-based tuberculosis and drug-resistance testing.

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