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Simplexa^® COVID-19 / Flu A/B & RSV Direct

Differential identification of the most prevalent respiratory viruses in one test

A real-time RT-PCR assay enabling the differential detection of SARS-CoV-2, influenza A, influenza B, and RSV within the same reaction using a single sample.

Disease state

Differential diagnosis of flu, COVID-19, and respiratory syncytial virus (RSV), especially during respiratory virus season, is essential for effective infection control and patient management. Co-infections involving SARS-CoV-2, influenza A and B viruses, and RSV have been reported, making accurate diagnosis more challenging; as these viruses share overlapping clinical symptoms, they can be difficult to distinguish based on presentation alone.

The 4 most relevant seasonal respiratory viruses: SARS-CoV-2, Flu A, Flu B, and RSV

The value of Simplexa^® COVID-19 / Flu A/B & RSV Direct

Detect and differentiate 4 common respiratory viruses with the newest member of the ever-expanding LIAISON^® MDX testing portfolio.

Fast time-to-result

Moderate complexity, sample-to-answer system with no RNA extraction and all-in-one reagents for use on nasal and nasopharyngeal swabs with results in under an hour.

Meets the needs of the post-pandemic respiratory landscape

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

Performance you need

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

How Simplexa^® COVID-19 / Flu A/B & RSV Direct works

The Simplexa^® COVID-19 / Flu A/B & RSV Direct is a qualitative real-time RT-PCR assay designed for in vitro use. Featuring a streamlined workflow that allows direct use of unextracted primary samples with ready-to-use PCR reagents, this assay runs on a re-usable Direct Amplification Disc using the compact LIAISON^® MDX system, offering operational simplicity, flexibility, and high-quality performance, making it suitable for a wide range of clinical laboratory settings.

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 under 60 minutes.

Intuitive LIAISON^® MDX Studio Software

Integrated QC checks and reporting for individual assays or use the multi-assay suite feature for compatible assays. View PCR curves and QC charts, Interface with LIS, and even access software during runs.

Indications for Simplexa^® COVID-19 / Flu A/B & RSV Direct use

Assay and system

A real-time RT-PCR assay run on LIAISON^® MDX to detect SARS-CoV-2, 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^® COVID-19 / Flu A/B & RSV workflow

Scan, load and go

Ready to use

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

Sample & easy workflow

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

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

Load

In each Disc Wedge:

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

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. These expansive capabilities come with a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.

LIAISON^® MDX

One instrument.
Multiple discs.
Ultimate Flexibility.

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