Skip to main content

Please select
your location below

Attenzione, le pagine di questa sezione sono disponibili solo in lingua inglese.

By selecting the International view, you verify that you reside outside of the USA and you wish to view DiaSorin Molecular’s International Product Information. This material is intended for International (non-USA) site visitors only.

Pursuant to the Guidelines of the Ministry of Health dated 28/03/2013 related to health advertising concerning medical devices, in vitro diagnostic medical devices and medical-surgical devices, we hereby inform you that the information contained in this website and to which you are going to access is exclusively intended for professionaloperators.

Simplexa™ COVID-19 & Flu A/B Direct

Differential Identification of the Most Prevalent Respiratory Viruses in One Test

A real-time RT-PCR assay enabling differential detection of SARS-CoV-2, influenza A, and influenza B from the same sample in the same reaction.

Disease state

Differential diagnosis of Flu and COVID-19, especially during Flu season, is vital to infection control and patient management. Co-infections with multiple respiratory viruses in the same patient have been reported, which present diagnostic challenges. Variants of SARS-CoV-2 and emerging strains of influenza may also lead to false negative detection by some molecular tests. With these challenges and since COVID-19 and influenza have overlapping symptoms, it is critical that laboratories are able to diagnose with an accurate test rapidly. The Simplexa® COVID-19 & Flu A/B Direct kit allows for the in vitro qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, and influenza B virus from nasopharyngeal swabs (NPS) with broad strain coverage for both the SARS-CoV-2 and influenza viruses to provide confidence in the results.

Need for Respiratory Virus Differential Diagnosis

The value of Simplexa™ COVID-19 & Flu A/B Direct

The first FDA-cleared assay for targeted differential diagnosis of Flu & COVID-19

Meets the needs of the evolving pandemic

RT-PCR assay enabling differential diagnosis of COVID-19, influenza A, and influenza B from the same sample in the same well.

Fast time-to-result

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

Confidence in your results

Evaluated over 80 flu strains & 2.3M SARS-CoV-2 sequences with ongoing monitoring of circulating Flu and SARS-CoV-2 strains delivering diagnostic confidence.

Performance you need with a multiplex

Sensitive and specific clinical detection across all targets without competitive interference observed within a multiplex assay.

How SimplexaTM COVID-19 & Flu A/B Direct works

Simplexa COVID-19 & Flu A/B Direct 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 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 SimplexaTM COVID-19 & Flu A/B Direct use

Assay and system

A real-time RT-PCR assay run on LIAISON® MDX to detect of Flu A, Flu B & SARS-CoV-2 in one sample

Patient types

Human patients with signs and symptoms of respiratory tract infection

Diagnostic lab

Hospital,  Commercial, Reference and Public Health laboratories

SimplexaTM COVID-19 & Flu A/B Direct 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

Scan

  • 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

Load

In each Disc Wedge:

  • Load 50 µl of sample
  • Load 50 µl of reaction mix
  • Close the foil and remove the tab 
03

Run Samples

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

  • Disc may be re-used up to 8 times (until all Wedges are utilized)

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. 

Molecular Diagnostic Tool LIAISON® Mdx - Diasorin

LIAISON® MDX

One instrument.
Multiple discs.
Ultimate Flexibility.

Discover more

Simplexa™ COVID-19 & Flu A/B Direct Ordering info

Part Name
Kit Size
Registration Status
Part Number

Simplexa™ COVID-19 & Flu A/B  Direct

24

IVD

MOL4250

Simplexa™ COVID-19 & Flu A/B Direct Positive Control Pack

10

IVD

MOL4260

Resources

Diasorin document repository

Dialog

Luminex document repository

Discover more

Research publications

Discover more

More details about SimplexaTM COVID-19 & Flu A/B Direct

Get in touch

If you need any information about our products, contact our specialists. 

Contact us

Need any help?

Get help with Diasorin products and services.

Ask for support