FDA Clearance for Direct Detection of Strep from Throat Swabs
Luminex Corporation has received FDA clearance for the ARIES® Group A Strep Assay, a moderate complexity, sample to answer test for the direct detection of Streptococcus pyogenes from throat swab specimens using the ARIES® System. This is the sixth assay the FDA has cleared for use on Luminex's ARIES® Systems in the last 24 months.
Fast and accurate diagnosis of Group A Streptococcus infections is critical to ensuring that appropriate antibiotic therapy is started promptly. For example, accurate diagnosis of Group A β-hemolytic Streptococcus pyogenes is crucial for determining the optimal treatment since physical examination alone is not sufficient to distinguish between pharyngitis caused by Group A β-hemolytic Streptococcus pyogenes and viral pharyngitis, or non-GAS bacterial organisms such as Fusobacterium necrophorum. Invasive cases of this infection lead to as many as 1,600 deaths in the United States each year, according to CDC estimates.
Dr. Ted E. Schutzbank, Technical Director, Specialized Testing and Microbiology at Ascension/St. John Providence said: "While the use of rapid antigen detection kits has been the standard of care in physicians' offices for years, the sensitivity of these tests has always been questionable, requiring follow-up testing of negative results, typically by bacterial culture. Delaying treatment while awaiting lab results can lead to serious short-term sequelae such as scarlet fever, or long-term complications such as rheumatic fever. Replacement of rapid antigen testing by the ARIES® Group A Strep Assay will allow for a much faster definitive diagnosis of these infections and greatly enhanced patient care by ensuring timely administration of antibiotic therapy."
Overuse of antibiotics has caused the resistance of numerous species of bacteria, so accurate diagnosis is pivotal to mitigating unnecessary antibiotic use and guiding appropriate patient treatment. Molecular testing for respiratory pathogens has been shown to improve infection control efforts and reduce the use of unnecessary antibiotics, duration of treatment, length-of-stay, and hospital admissions.
The ARIES® Group A Strep Assay, a real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test, is part of Luminex's comprehensive respiratory testing menu that also includes the ARIES® Bordetella Assay, ARIES® Flu A/B & RSV Assay, NxTAG® Respiratory Pathogen Panel, and VERIGENE® Respiratory Pathogens Flex Test.
Date Published: 7th November 2017
Source article link: Luminex Corporation