DeepChek® Assay 13-Plex KB Drug Susceptibility Testing (CE-IVD)

Intended use
The DeepChek® Assay 13-Plex KB Drug Susceptibility Testing is a single multiplex polymerase chain reaction (PCR) in vitro diagnostic test intended for the amplification of relevant portions of the Mycobacterium tuberculosis (MTB) complex DNA from unprocessed sputum specimens, concentrated sediments prepared from sputums or from MTB-positive culture.
In specimens where MTB is detected, the DeepChek® Assay 13-Plex KB Drug Susceptibility Testing might aid in the determination of tuberculosis (TB) bacteria resistance with the detection of resistance associated mutations in MTB targeted genes (e.g., ethionamide (ETH) resistance associated with inhA promoter mutations only; fluoroquinolone (FLQ) resistance associated mutations in the gyrA and gyrB quinolone resistance determining regions (QRDR); and second line injectable drugs (amikacin, capreomycin, and kanamycin) associated mutations in the rrs gene and the eis promoter region, ….).
The DeepChek® Assay 13-Plex KB Drug Susceptibility Testing is intended for use by trained laboratory personnel specifically instructed and trained in the techniques of PCR and next generation sequencing (NGS) workflows.
The DeepChek® Assay 13-Plex KB Drug Susceptibility Testing is intended for use as a reflex test for a specimen (unprocessed sputum, concentrated sputum sediments or culture) that is determined to be MTB positive.
This nucleic amplification test is indicated for use on previously diagnosed MTB patients ONLY. This test is NOT intended to be used as a screening or confirmation test for the detection, confirmation and quantification in human specimens of markers of TB infection.

For “In-Vitro Diagnostic use (IVD)” where indicated : CE marking only valid for EEA and territories recognizing it. Otherwise “For Research Use Only” (RUO): not for use in diagnostic procedures, no claim or representation is intended to provide information for the diagnosis, prevention, or treatment of disease.