Healthcare-Associated Infection & AMR
MoiM CPE Detection Kit
Export-only Approval
Category
| Intended Use | An in vitro diagnostic medical device intended to aid in the diagnosis of carbapenemase-producing Enterobacterales (CPE) infection by detecting carbapenemase resistance genes (KPC, NDM, and OXA-48-like) in genomic DNA extracted from rectal swab specimens collected from patients suspected of CPE infection, using multiplex real-time polymerase chain reaction (PCR) technology. |
| Target Genes | KPC, NDM, OXA-48 |
| Sample Types | Rectal Swab |
| Sample Volume | 250 uL |
| LoD | KPC 9.26 x 10^1 CFU/mL NDM 6.63 x 10^0 CFU/mL OXA-48 3.32 x 10^1 CFU/mL |
| Target Specificity | (To be added after clinical trials) |
| Turnaround Time | 70min |