Rapid Test Identifies Bacteria from Blood Culture

The assay uses peptide nucleic acid (PNA) probes to target species-specific ribosomal ribonucleic acid (rRNA) in live bacteria and yeast coupled with highly sensitive and specific fluorescence in situ hybridization (FISH).

The GNR Traffic Light PNA FISH test is capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa directly from positive blood cultures containing Gram-negative rods. The unique properties of the noncharged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that do not require the extensive sample preparation necessary for other nucleic acid technologies.

The assay is manufactured by AdvanDX, (Woburn, MA, USA) and has received 510(k) clearance from the US Food and Drug Administration (FDA; Silver Spring, MD, USA). The test is the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH diagnostics platform designed to provide rapid, therapy-guiding results that enable clinicians to provide early, effective therapy for patients with Gram-negative bloodstream infections (BSI).

The GNR Traffic Light PNA FISH assay will enable microbiology laboratories to identify and report E. coli, K. pneumoniae, and P. aeruginosa from positive blood cultures 24-48 hours earlier than traditional methods. The rapid results will provide clinicians a "head start" on selecting appropriate and effective therapy for patients with Gram-negative bloodstream infections, which studies show may improve clinical outcomes, reduce incidence of adverse events and shorten hospital length of stay.

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