A new test for Gram-negative bacterial infections such as E. coli has been launched in Europe.
The GNR Traffic Light test, which has CE-IVD Mark approval in Europe, is the latest addition to AdvanDx's PNA FISH molecular diagnostics platform.
The new test is the first means of simultaneously diagnosing Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from blood samples in less than 90 minutes.
The GNR Traffic Light test provides rapid results, enabling clinicians to intervene early when patients have Gram-negative bloodstream infections. The test's name comes from its results: E. coli shows up green, K. pneumoniae yellow and P. aeruginosa red.
Patients with bloodstream infections due to these three serious pathogens spend an average of 15 days in hospital, with mortality rates as high as 40%.
The danger of Gram-negative bacteria is partly due to their increasing resistance to antibiotics. The spread of the NDM-1 gene, which confers antibiotic resistance on Gram-negative strains of bacteria, increases the need for a rapid and effective test.
Conventional laboratory testing methods take over 24 hours to identify the causative pathogen. The need for interim measures can lead to unnecessary treatment with broad-spectrum antibiotics, or to inadequate treatment if virulent pathogens are not suspected.
Studies have shown that gaining a 24-hour 'head start' with appropriate narrow-spectrum therapy for Gram-negative bloodstream infections may improve clinical outcomes and reduce the incidence of adverse events. GNR Traffic Light PNA FISH provides clinicians with accurate results in hours rather than days.
"This latest PNA FISH test provides another tool to help laboratories and clinicians improve antibiotic selection, care and outcomes for critically ill patients with bloodstream infections," said Thais T. Johansen, President and CEO of AdvanDx.