Clinical evaluation of the Akonni Biosystems XDR-LFC assay for the molecular detection of isoniazid, rifampin, fluoroquinolone, kanamycin, capreomycin, and amikacin drug resistance

The Akonni Biosystems XDR-TB TruArray and lateral-flow cell (XDR-LFC) is a novel assay that detects mutations in seven genes associated with resistance to antituberculosis drugs: katG, inhA promoter, and ahpC promoter (isoniazid), rpoB (rifampin), gyrA (fluoroquinolones), rrs and eis promoter (kanamycin), and rrs (capreomycin and amikacin). This study evaluated assay performance using direct sputum samples from 566 participants recruited in a prospective cohort in Moldova over two years. Whole genome sequencing was performed on a subset of samples to evaluate for concordance and discordance and supplement the phenotypic drug susceptibility testing reference.