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P19

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

Introduction:

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. 

 

Methods: 

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.

 

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.

 

Discussion:

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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