Beta-hemolytic Streptococcus pyogenes, known as Group A Strep, causes strep throat, scarlet fever, and other serious health problems. Pharyngitis, the broader category into which Streptococcal pharyngitis falls, is diagnosed in 11 million people annually in the United States.1
Accurate diagnosis of Group A Strep is critical for appropriate treatment and mitigating unnecessary antibiotic use. The ARIES® Group A Strep Assay is a real-time PCR-based qualitative in vitro diagnostic test for the direct detection of Group A β-hemolytic Streptococcus in throat swab specimens from patients with signs and symptoms of pharyngitis. The assay is FDA cleared and CE Marked for IVD use.
The ARIES® Group A Strep Assay delivers higher sensitivity and specificity than existing rapid tests, and a faster turnaround time than culture methods.2
ARIES® Group A Strep Assay Offers:
|ARIES® Group A Strep Assay|
|Sensitivity||97.5%||93.7% – 99.0%|
|Specificity||97.8%||96.0% – 98.8%|
|PPV||94.0%||89.3% – 96.7%|
|NPV||99.1%||97.7% – 99.7%|
|1. Two (2) of the ARIES® Group A Strep Assay negative specimens that were positive by bacterial culture followed by identification with MALDI-TOF MS (i.e. False Negative) were Group A Strep negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® Group A Strep Assay.
2. Seven (7) of the ARIES® Group A Strep Assay positive specimens that were negative by bacterial culture followed by identification with MALDI-TOF MS (i.e. False Positive) were positive by bi-directional sequencing analysis using ana- lytically validated primers that targeted genomic regions distinct from the ARIES® Group A Strep Assay.
3. Five (5) specimens generated inconclusive results by comparator culture method (MALDI-TOF MS log(score) <2.00). All five specimens were excluded from the device performance calculations.
Please see the Package Insert for more detailed information.
The operator simply adds specimen to the sample chamber, puts the cassette in the magazine, loads the magazine into the ARIES® System, and the run will start automatically.
Load the sample into the cassette
Insert up to six cassettes into the magazine
Insert the magazines into the instrument
Review & release results
|Luminex Online Order Management|
|Phone:||+31 (0)73 800 1900|
|Fax:||+31 (0)73 800 1998|
|Product Name||Kit Size||Registration Status||Part Number|
|ARIES® Group A Strep Assay
Does not include assay protocol file kit (CN-0385-01)
|24 Tests||CE Marked||50-10041|
|ARIES® Group A Strep Assay Protocol File Kit
(one time order only)
|ARIES® Two Module System
|1 unit||CE Marked||ARIES-M12V1-IVD|
|ARIES® M1 System
|1 unit||CE Marked||ARIES-M6V1-IVD|
|SYNCT™ Software||CE Marked||CN-SW47|
For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.
The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis.
The ARIES® Group A Strep Assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.
The ARIES® Group A Strep Assay is indicated for use with the ARIES® Systems.
ARIES® Systems are class 1(I) laser products.
Validation of the LIS compatibility must be performed by the end user.