Direct Detection of Streptococcus pyogenes Nucleic Acid in Throat Swab Specimens
ARIES® Group A Strep Assay Overview
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
The ARIES® Group A Strep Assay Offers:
- Specificity—Identify patients with Streptococcus pyogenes infection to aid in the diagnosis of pharyngitis
- Flexibility—Run as many as 12 tests per batch, supporting STAT testing and low- to medium-volume batch testing
- Fast Time to Results—Answers in less than two hours with minimal hands-on time to support rapid treatment decisions
- Full Integration—All aspects of testing are automated, from sample preparation through analysis, to enable easy implementation on weekends and night shifts
- Error-reducing Safeguards—Internal barcode scanning matches samples to cassettes and may reduce data input errors
In this webinar, Dr. Paul Lephart of the University of Michigan explores “The Group A Strep Diagnostic Algorithm” He also reviews testing requirements, the prevalence in specific demographics and geographies, the benefits and drawbacks of various testing methodologies, and the testing needs in today’s variety of healthcare settings. Click here to download webinar summary.
ARIES® Group A Strep Assay Performance Compared to Bacterial Culture Followed by Identification with MALDI-TOF MS
|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
Ordering Information for ARIES® Group A Strep
|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
Includes instrument, system operation manual, two magazines, quick guide (IVD), two sample prep trays, power cord, and handheld barcode scanner and stand
|1 unit||CE Marked||ARIES-M12V1-IVD|
|ARIES® M1 System
Includes instrument, system operation manual, one magazine, quick guide (IVD), two sample prep trays, power cord, and handheld barcode scanner and stand
|1 unit||CE Marked||ARIES-M6V1-IVD|
|SYNCT™ Software||CE Marked||CN-SW47|
ARIES® Group A Strep Resources:
ARIES® Group A Strep Assay – Product Sheet
ARIES®—Welcome to the New Way to Work – Product Sheet
ARIES® M1—Welcome to the New Way to Work – Product Sheet
Lean Labs: Delivering More with Less – White Paper
- Choby BA. “Diagnosis and treatment of streptococcal pharyngitis“. Am Fam Physician. 2009 March;79(5):383–90. PMID 19275067.
- Pearl of Knowledge, Evidence Based Summaries: Testing for Group A Streptococcal Pharyngitis. Health Partners, Institute for Education and Research (Internet). Cited 2017 October. Available from: https://www.healthpartners.com/ucm/groups/public/@hp/@public/@ime/@content/documents/documents/cntrb_033286.pdf.
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.