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Simplexa® Flu A/B & RSV Direct Gen II

Comprehensive flu strain coverage and monitoring ensure test confidence

The latest generation assay entrusts higher confidence to detect influenza and RSV viruses and is compatible with the Simplexa® COVID-19 Direct assay to differentiate Flu, RSV, and SARS-CoV-2.

Disease state

Influenza viruses cause mild to severe respiratory illness with hospitalization or death, especially in elders, children, and people with health conditions. Influenza A viruses may cause flu pandemics when a new influenza A virus strain emerges with the ability to infect and spread efficiently. While more combinations exist, 131 subtypes have been detected, and circulating subtypes in people are A(H1N1) and A(H3N2).

Influenza B viruses are not divided into subtypes but rather classified into two lineages: B/Yamagata and B/Victoria. These change more slowly in terms of their genetic and antigenic properties than influenza A viruses, have a slower circulation, and vary by geography.

RSV also infects the respiratory tract, and more severe infections like pneumonia or bronchiolitis may occur in babies, those with other medical conditions, e.g., asthma, and those over 65 years with chronic heart or lung disease or compromised immune systems.

Influenza and RSV are major seasonal health burdens

The value of Simplexa® Flu A/B RSV Direct Gen II

This new-generation assay meets the needs of today's respiratory testing

Flexibility for your lab

Simplexa® Flu A/B & RSV Direct Gen II assay and Simplexa® COVID-19 Direct assay can be run on the same disc and run on the LIAISON® MDX for virus differential diagnosis from one patient sample.

Sample-to-answer workflow

Easy-use sample-to-answer system with no RNA extraction and all-in-one reagents for use on nasopharyngeal swabs.

Reliable Flu A/B & RSV detection

Over 100 Flu strains & multiple RSV A/B types were evaluated with ongoing monitoring of circulating Flu and vaccine strains delivering diagnostic confidence.

Clinical performance you need

Excellent sensitivity and specificity with 100% positive percent agreement (PPA) and 97.8% negative percent agreement (NPA) Flu A/B. 100% PPA and 96.8% NPA for RSV.

How Simplexa® Flu A/B RSV Direct Gen II works

Simplexa® Flu A/B RSV Direct Gen II is an in-vitro qualitative real-time RT-PCR assay with a simple workflow, enabling unextracted primary sample and ready-to-use PCR reagent loading on a re-usable Direct Amplification Disc on the compact LIAISON MDX system designed for operational simplicity, flexibility, and quality assurance for utility across any clinical lab.

01

Sample-to-answer

Scan 1-8 primary unextracted samples per run, ready-to-use single-use reaction mix vials, and the 8-well Direct Amplification Disc. Simply load samples and reagents directly onto the disc, place the disc on the LIAISON® MDX Instrument, and press run for results in 90 minutes.

02

Intiutive LIAISON® MDX Studio Software

Integrated QC checks and reporting for individual assays or use the multi-assay suite feature for compatible assays- Simplexa® Flu A/B & RSV Gen II Direct Simplexa® COVID-19 Direct is compatible with the Simplexa® COVID-19 Direct in the same run. View PCR curves and QC Charts, Interface with LIS, and even during run access software.

Indications for Simplexa® Flu A/B & RSV Gen II Direct use

Assay and system

A real-time RT-PCR assay run on  LIAISON® MDX  to detect of  Flu A, Flu B & RSV in one sample

Patient types

Human patients with signs and symptoms of respiratory tract infection

Diagnostic lab

Hospital,  Commercial, Reference and Public Health laboratories

Simplexa® Flu A/B RSV Direct Gen II workflow

Scan, load and go

Ready to use

  • No prep &  No waste
  • Single use reagents (24 reactions)
  • No mixing, pouring or rehydrating

Simple & easy workflow

  • No extraction needed, direct sample input
  • Liquid sensor to ensure adequate sample volume metered: No precise pipetting required
  • CLIA Moderate Complexity
01

Scanning

  • Scan the assay definition QR code (upon first use only)
  • Scan the lot-specific QR code on a vial or card
  • Scan the disc barcode
  • Scan the sample barcode
02

Loading

In each Disc Wedge:

  • Load 50 µl of sample
  • Load 50 µl of reaction mix (= 1 vial content) 
  • Close the foil and remove the tab Disc may be re-used up to 8 times (until all Wedges are utilized)
  • Close the foil and remove the tab
03

Load and run

Load the disc onto the LIAISON® MDX and start the  run. The results and a final report are automatically generated by the software.

To be used on the LIAISON® MDX Instrument

The LIAISON® MDX is an innovative and powerful real-time PCR instrument with two consumable disc options: the 8-well Direct Amplification Disc and the 96-well Universal Disc for higher volume testing.

Supported by an expanding menu of molecular assays, the system provides easy-to-understand results with the ability to check amplification curves after a run. All of this in a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.

LIAISON MDX

LIAISON® MDX

One instrument.
Multiple discs.
Ultimate Flexibility.

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Simplexa® Flu A/B RSV Direct Gen II ordering info

Part Name
Kit Size
Registration Status
Part Number

Simplexa® Flu A/B & RSV Gen II Direct

24

IVD

MOL2655

Simplexa® Flu A/B & RSV Direct Positive Control Pack

10

IVD

MOL2660

Resources

Diasorin document repository

Dialog

Luminex document repository

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Research publications

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More details about Simplexa® Flu A/B RSV Direct Gen II

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