Nanosphere's Verigene Gram-positive blood culture test has demonstrated 100% sensitivity and specificity for detection of drug-resistant bacteria MRSA and VRE, and an overall sensitivity of 98.4% for a broad panel of bacterial targets.
The Verigene system is an easy-to-use cartridge-based platform that enables rapid, cost-effective, multiplexed testing in a near-patient setting.
The automated test produced results for 13 bacterial identification targets and three antibiotic resistance targets within two and a half hours.
Current microbiological culture methods take between 24 and 48 hours to identify bacterial pathogens and determine their resistance or susceptibility to common antibiotics.
The test is currently for investigational use only, but is pending CE-IVD and US Food and Drug Administration review and clearance, the company said.