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ARIES® FLU A/B & RSV ASSAY

ARIES® Flu A/B & RSV Assay (US-IVD)

The ARIES® Flu A/B & RSV Assay detects and differentiates three respiratory pathogens using a sample to answer platform

ARIES® Flu A/B & RSV Assay Overview

 

 

The ARIES® Flu A/B & RSV Assay is a rapid, accurate method for the detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) from nasopharyngeal swab (NPS) specimens using ARIES® Systems.

 

Influenza A, influenza B, and respiratory syncytial virus (RSV) are contagious human viral pathogens that are transmitted from person to person primarily by aerosolized virus-containing droplets (influenza) or contaminated secretions (RSV) which can result in respiratory disease. Infections occur in all age groups, and cause significant health / financial concerns worldwide.1

 

ARIES® Flu A/B & RSV Assay Offers:

 

  • High Sensitivity—High clinical performance reduces need for confirmatory testing, reduces time to treatment.
  • High Accuracy—Confidence in results gives patients and clinicians peace of mind, and helps ensure correct treatment.
  • Fast Time to Results—Answers in as little as two hours will allow physicians to counsel patients and treat sooner to decrease disease transmission.
  • Full Integration—Automate all aspects of testing, from sample preparation through analysis, to reduce human error.

 

Performance

 

The clinical performance of the ARIES® Flu A/B & RSV Assay was evaluated using leftover, de-identified, nasopharyngeal swab (NPS) specimens prospectively collected from pediatric or adult patients suspected of having a respiratory tract infection during the 2014/2015 and 2015/2016 flu seasons.

 

The reference/comparative method used to evaluate the clinical performance of ARIES® Flu A/B & RSV Assay was an FDA-cleared molecular comparator assay

 

ARIES® Flu A/B & RSV Assay Performance for Influenza A (N=2479)

 

ARIES® Flu A/B & RSV AssayReference 
 PositiveNegativeNo CallTOTAL
Positive2993421334
Negative131213112145
No Call0000
TOTAL312216522479
  95% Cl  
Positive Percent Agreement95.8%93.0% – 97.8%  
Negative Percent Agreement98.4%97.8% – 98.9%  

1. Seven (7) ARIES® Flu A/B & RSV Assay negative specimens that were positive by the reference method (i.e., False Negative) were confirmed as negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® Flu A/B & RSV Assay.

2. Four (4) ARIES® Flu A/B & RSV Assay positive specimens that were negative by the reference method (i.e., False Positive) were confirmed as positive by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® Flu A/B & RSV Assay.

 

 

ARIES® Flu A/B & RSV Assay Performance for Influenza B (N=2479)

 

ARIES® Flu A/B & RSV AssayReference 
 PositiveNegativeNo CallTOTAL
Positive45142059
Negative31241702420
No Call0000
TOTAL48243102479
  95% Cl  
Positive Percent Agreement93.8%82.8% – 98.7%  
Negative Percent Agreement99.4%99.0% – 99.7%  

1. Two (2) ARIES® Flu A/B & RSV Assay negative specimens that were positive by the reference method (i.e., False Negative) were confirmed as negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® Flu A/B & RSV Assay.

2. Three (3) ARIES® Flu A/B & RSV Assay positive specimens that were negative by the reference method (i.e., False Positive) were confirmed as positive by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® Flu A/B & RSV Assay.

 

 

ARIES® Flu A/B & RSV Assay Performance for RSV (N=2479)

 

ARIES® Flu A/B & RSV AssayReference 
 PositiveNegativeNo CallTOTAL
Positive2703620306
Negative81216502173
No Call0000
TOTAL278220102479
  95% Cl  
Positive Percent Agreement97.1%94.4% – 98.7%  
Negative Percent Agreement98.4%97.7% – 98.9%  

1. One (1) ARIES® Flu A/B & RSV Assay negative specimen that was positive by the reference method (i.e., False Negative) was confirmed as negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® Flu A/B & RSV Assay.

2. Thirty-two (32) ARIES® Flu A/B & RSV Assay positive specimens that were negative by the reference method (i.e., False Positive) were confirmed as positive by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® Flu A/B & RSV Assay.

 

Please see package insert for more detailed information.

Workflow

 

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.

 

ARIES® Flu A/B & RSV IVD Assay Workflow 

Ordering Information

 

Luminex Online Order Management
Email:[email protected]
Phone:1-512-336-3550
Toll Free:1-866-401-5450
Fax:1-512-219-0544
Fax (Europe, Middle East, India, Asia):+31 (0)73 800 1998
Product NameKit SizeRegistration StatusPart Number
ARIES® Flu A/B & RSV Assay24 testsUS-IVD50-10020
ARIES® Flu A/B & RSV Assay Protocol File Kit
(one time order only)
 US-IVDCN-0335-01
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 unitUS-IVD
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 unitUS-IVD
CE Marked
ARIES-M6V1-IVD
SYNCT™ Software US-IVD
CE Marked
CN-SW47-01
  1. ARIES® Flu A/B & RSV Assay, Package Insert (US-IVD)

 

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.

Intended Use (US-IVD)

The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C.

Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection.

Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems.

The ARIES® System is a class 1(I) laser product.

Validation of the LIS compatibility must be performed by the end user.