Tuberculini - CE-IVD test for genotyping M. tuberculosis infections
The intended use of CLX101 is to determine the DNA sequence of pre-identified regions of interest on the genome of Mycobacterium tuberculosis from DNA extracted from primary clinical samples (i.e. sputum or bronchioalveolar lavage), or DNA extracted from cultures or isolates derived from clinical specimens. The presence of M. tuberculosis shall be confirmed in patients prior to the usage of CLX101. The regions of interest have been chosen to contain resistance and lineage associated mutations. The report generated by CLX101SW is intended to support the decision making of the treating physician, in guiding the choice of the antibiotic therapy.
CLX101S5 is intended for single use as in one library preparation including 24 DNA samples. This assay is not indicated for use as a stand-alone diagnostic for determining the presence of M. tuberculosis.
What can it do
- Work directly from sputum samples
- Detect resistance mutations against 12 antibiotics based on the WHO list
- Classify strains into lineages based on Coll et al.
- Turnaround time in 48 hours
- 6 hours hands-on time
- 24 samples per batch
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