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VERIGENE® RESPIRATORY PATHOGENS FLEX TEST

VERIGENE® Respiratory Tract Infection Tests | VERIGENE® Respiratory Pathogens Flex Test

The VERIGENE® Respiratory Pathogens Flex Test (RP Flex) is a flexible multiplex panel that addresses the full continuum of respiratory testing needs

The VERIGENE® Respiratory Pathogens Flex Test (RP Flex) is an automated, multiplexed, flexible nucleic acid test for the identification of the viruses and bacteria that most commonly cause respiratory infections.

 

Respiratory testing needs vary by season, geography, and even from patient to patient. Yet currently, to meet diverse testing needs, labs must choose between running expensive mega-panels on all samples, offering an assortment of overlapping small and large panels, or utilizing costly sendouts. RP Flex is a single panel that addresses the full spectrum of respiratory testing needs in a cost-effective manner — one platform, one comprehensive panel, and finally, the flexibility to use and pay for only what you need.

 

How does Flex™ testing work?

 

Each RP Flex cartridge contains a broad panel of 16 viral and bacterial targets. Any combination of targets can be selected for an individual sample at the time of test ordering. Additional results not initially reported after test completion can be reflexed instantly at an extra cost without running an additional test.

 

You pay only for the targets you use.

Scenario 1
One-size-fits-all
respiratory panel
 
Reagent Cost per 1,000 Samples
Flu Only (60%) $ 78,000
Flu/RSV (15%) $ 19,500
Expanded RVP (20%) $ 26,000
Pertussis (5%) $ 6,500
TOTAL
  $ 130,000
Scenario 2
Molecular Flu/RSV test AND One-size-fits-all
respiratory panel
Reagent Cost per 1,000 Samples
Flu Only $ 42,000
Flu/RSV $ 10,500
Expanded RVP $ 26,000
Pertussis $ 6,500
TOTAL
  $ 85,000
Scenario 3
 
VERIGENE RP Flex
 
Reagent Cost per 1,000 Samples
Flu Only $ 30,000
Flu/RSV $ 10,500
Expanded RVP $ 22,000
Pertussis $ 2,500
TOTAL
  $ 65,000

Respiratory Pathogens Flex Test Specifications

 

Targets U.S./FDA-Cleared Outside U.S.
Viruses
Adenovirus
Human Metapneumovirus
Influenza A
Influenza A (subtype H1)
Influenza A (subtype H3)
Influenza B
Parainfluenza 1
Parainfluenza 2
Parainfluenza 3
Parainfluenza 4
Rhinovirus
RSV A
RSV B
Bacteria
Bordetella pertussis
Bordetella parapertussis/B. bronchiseptica
Bordetella holmesii

 

Key Features
Automation Sample to Result
Instrumentation VERIGENE Reader and Processor SP
Workflow On-Demand and Scalable
Pipetting Steps One
Hands-On Time <5 minutes
Run Time <2 hours
Pricing Fixed or Flex

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

The VERIGENE® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. The test is performed on the automated VERIGENE System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and microarray hybridization to detect gene sequences of the following organism types and subtypes: Viruses (Adenovirus, Human Metapneumovirus, Influenza A, Influenza A (subtype H1), Influenza A (subtype H3), Influenza B, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, and Rhinovirus) and Bacteria (Bordetella parapertussis/bronchiseptica, Bordetella holmesii, and Bordetella pertussis).

Detecting and identifying specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or patient management decisions.

Negative results in the presence of a respiratory illness do not preclude respiratory infection and may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by an NPS specimen. Conversely, positive results do not rule-out infection or co-infection with organisms not detected by RP Flex. The agent(s) detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation may be necessary to establish a final diagnosis of respiratory infection.

Clinical evaluation indicates a lower sensitivity specific to RP Flex for the detection of Rhinovirus. If infection with Rhinovirus is suspected, negative samples should be confirmed using an alternative method.

Performance characteristics for influenza A were established when influenza A/H1 (2009 Pandemic) and A/H3 were the predominant influenza A viruses in circulation. RP Flex may not detect novel Influenza A strains. 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 used specifically for novel virulent Influenza viruses and sent to appropriate health authorities for testing. Viral culture should not be attempted in these cases unless a biosafety level (BSL) 3+ facility is available to receive and culture specimens.