O.K.N.V.I. RESIST-5 Rapid Test - India CDSCO Medical Device Registration

Product Information

Carbapenemase-producing Organisms (TRURAPID® RESIST CTX-M Rapid Test), and more specifically, Carbapenem resistant Enterobacteriaceae (TRURAPID® RESIST CTX-M Rapid Test) represent a major public health concern worldwide due to their broad spectrum of resistance to antibiotics including, besides carbapenems, most classes of antimicrobial agents, and thus leaving very few options for the management of infected patients. Besides CREs, CPOs also include nonfermenting Gram-negative bacilli (TRURAPID® RESIST CTX-M Rapid Test), such as Pseudomonas aeruginosa and Acinetobacter baumannii that exhibit resistance not only to beta lactam and other groups of antibiotics, but also to carbapenems. Inhibitor-based phenotypic confirmatory tests exist for the confirmation of class A (TRURAPID® RESIST CTX-M Rapid Test) and class B (TRURAPID® RESIST CTX-M Rapid Test) carbapenemases, Nowadays, definitive confirmation of CPO resistance mechanism relies on molecular assays. These tests are expensive and can only be performed in dedicated environment and by skilled personnel, hence limiting their more generalized usage. TRURAPID® OKNVI RESIST-5 Rapid Test test is part of TRURAPID range of antimicrobial resistance diagnostic tests. It is intended to be used by healthcare professionals to aid in the diagnosis of carbapenemases in bacterial culture. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of health care providers. Alternative test method(TRURAPID® RESIST CTX-M Rapid Test) should be considered to confirm the test result obtained by this device