MDR Direct Flow Chip Kit

INTENDED USE​

“Multidrug Resistance (MDR) Direct Flow Chip is an in vitro diagnostic kit that allows rapid qualitative
detection of multidrug-resistant bacteria. It is based on multiplex PCR and includes the detection of 5
bacterial species (S. aureus, K. pneumoniae, P. aeruginosa, E. coli and A. baumannii) and a total of 55
resistance markers including the main “enzymatic” type mechanisms described for nine different antibiotic
classes: lactams, glycopeptides, oxazolidiones, macrolides, aminoglycosides, sulfonamides,
fluoroquinolones, polymyxins, chloramphenicol, as well as point mutations most frequently detected in
fluoroquinolone-resistant strains of E. coli and P. aeruginosa. Among these, the kit detects fifteen genes that
offer resistance to carbapenem (kpc allele): 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20,
21, 22 and 23, sme allele: 1, 2, 3, 4 and 5, nmc/imi allele: 1, 2, 3, 4, 5, 6, 7, 8 and 9, ges allele: 1, 2, 3, 4, 5, 6,
7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 and 26, vim allele: 1, 2, 3, 4, 5, 6, 7, 8, 9,
10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,
39, 40, 41, 42, 43, 44, 45 and 46, gim allele: 1 and 2, spm, ndm allele: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
14, 15 and 16, sim, imp3, 15, 19_like allele: 1, 2, 3, 5, 6, 8, 9, 10, 11, 15, 19, 20, 21, 24, 25, 28, 29, 30, 40, 41,
42 and 47, oxa23_like allele: 23, 27, 49, 73, 133, 146, 165, 166, 167, 168, 169, 170, 171 and 225, oxa24_like
allele: 24, 25, 26, 40, 72, 139 and 160, oxa48_like allele: 48, 162, 163 and 181, oxa51_like allele: 51, 60, 65,
66, 67, 68, 69, 70, 75, 76, 77, 78, 79, 80, 82, 83, 84, 88, 89, 90, 91, 92, 93, 94, 95, 98, 99, 106, 107, 108, 109,
110, 111, 112, 113, 115, 116, 117, 128, 130, 131, 132, 138, 144, 148, 149, 150, 172, 173, 174, 175, 176, 177,
178, 179, 180, 195, 196, 197, 194, 200, 201, 202, 203, 206, 208 and 223, oxa58_like allele: 58, 96, 97 and
164).

The tests is performed directly on rectal exudates, nasopharyngeal exudates/aspirates and/or blood
cultures in infected patients or patients at risk for colonization as a measure to help in the control and
prevention of this type of infections. The method is based on amplification of DNA targets through multiplex
PCR reaction, and subsequent reverse dot-blot hybridization on a membrane that contains specific probes.

Target genes used for amplification of antibiotic and bacterial resistance markers in MDR Direct Flow Chip kit

Microbiological status: Non-sterile product.

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