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Implementation and evaluation of the ABL-DeepChek 13-Plex Assay for diagnosis of antibiotic resistant tuberculosis

V Mohr(1,2) C Utpatel(1,2) C Sayada(3) S Niemann(1,2)

1:Molecular and Experimental Mycobacteriology, Research Center Borstel, Germany; 2:National Tuberculosis Reference Laboratory, Research Center Borstel, Germany; 3:ABL Diagnostics S.A, France


Emerging resistances against anti Tuberculosis (TB) drugs are a major risk to global health security. Therefore, rapid resistance detection is crucial for effective and successful treatment and thereby essential to prevent transmission. A promising alternative, solving the major problems of phenotypic drug susceptibility testing (pDST) and Whole Genome Sequencing (WGS), is targeted next generation sequencing (tNGS) allowing for fast, sensitive and high-throughput decoding of MTBC strains genetic information. Here we present the evaluation of the ABL-DeepChek 13-Plex Assay for diagnosis of antibiotic resistant Tuberculosis (ABL Diagnostics S.A.), on the basis of detected mutation profiles. 



The concordance of detected mutations as well as resistance predictions is determined by comparing tNGS data to WGS data. For the data analysis both the ABL BacterioChek web tool and a modified MTBseq pipeline are used to independently verify and compare the results.



Of all in BacterioChek detected mutations, 567 (94.4%) were concordant to the WGS data. Furthermore, resistance inference of the ABL-DeepChek 13-Plex Assay 1.2, starting from culture gDNA, matched the predictions from WGS in 1146 (89.1%) observations. For DNAs from sputum specimens, 450 (90.7%) predictions agreed. Discrepancies were mainly based on different resistance prediction catalogues and rules.



tNGS with the DeepChek Assay 13-Plex KB Drug Susceptibility Testing v.1.2 has the potential to replace pDST for a large fraction of patients. It is an end-to-end solution for rapid resistance and drug susceptibility testing in TB diagnostics.

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