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.

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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 Simplexa^TM 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 Simplexa^TM 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

Simplexa^TM 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.