Nanosphere's Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) (IUO), based on the company's proprietary array-based nanoparticle technology, demonstrated overall sensitivity and specificity of 99%, respectively, for the detection of a broad panel of gram-positive bacteria from positive blood cultures, according to a recent study. The BC-GP Test also correctly detected the presence or absence of genes encoding vancomycin resistance in Enterococcus spp. and methicillin resistance in Staphylococcus aureus or S. epidermidis. Researchers concluded that the test, which required less than 5 minutes of user hands-on time, provided accurate organism identification and detection of resistance genes compared to routine laboratory methods.
The investigator-initiated study, showcased in an oral presentation Saturday, October 20 at the inaugural IDWeek(TM) in San Diego, California, was conducted by Dr. Sandra Richter and colleagues at the Cleveland Clinic in Cleveland, Ohio. Nanosphere funded the research.
Rapid identification of pathogenic bacteria from blood cultures can greatly reduce length of hospital stay and improve patient outcomes. Benefits of rapid diagnosis are widely recognized and include increased survival rates, decreased costs of patient care, and reduced dosage of unnecessary antibiotics. Current microbiological culture techniques take 24-48 hours to identify bacterial pathogens and determine their resistance or susceptibility to common antibiotics.
Recently FDA-cleared, the BC-GP Test (IVD) notably expands Nanosphere's automated sample-to-result Verigene® platform to include an infectious disease test capable of rapid detection of bacteria that can cause deadly bloodstream infections. The automated BC-GP Test detects 12 bacterial targets and 3 antibiotic resistance targets in less than two and a half hours with less than 5 minutes hands-on time. The Respiratory Virus Plus Nucleic Acid Test (RV+) is an FDA-cleared in vitro diagnostic test for the detection of multiple respiratory viruses and virus subtypes. A sample-to-result test for C. difficile is currently pending FDA review, while tests for gram-negative blood cultures and enteric bacteria and viruses are currently in development and in clinical trials, respectively.