Gram-Positive

cassette-fda-approved

Gram-Positive Cassette

The iCubate iC-GPC Assay™ is a multiplexed, in vitro diagnostic test for the rapid detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI).  Traditional culture techniques may require 2-4 days to identify both the causative organism and resistance profile, resulting in delayed treatment and increased costs.  The iC-GPC Assay™ provides bacterial identification and resistance determination from positive blood cultures up to 48 hours faster than conventional methods, improving time to treatment and patient outcomes. The iC-GPC Assay™ detects five of the most common gram positive organisms associated with BSI as well as three clinically significant resistance markers:

Bacterial Species Resistance Markers
Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus pneumoniae

Enterococcus faecalis

Enterococcus faecium

mecA– associated with methicillin resistance

vanA- associated with vancomycin resistance

vanB– associated with vancomycin resistance

FDA Cleared

iCubate® Technology Creates a Unique, One-Step Multiplex PCR MDx Platform which has the ability to perform simple extraction, amplification, and detection, all in a multiplexed, automated, and closed system.

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