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.
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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; since 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
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 anterior nasal swabs 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 observed within a multiplex assay.
How Simplexa® COVID-19/ Flu A/B & RSV Direct works
Simplexa® COVID-19 / Flu A/B & RSV 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.
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.
Simplexa® COVID-19/ Flu A/B & RSV 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
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
- Load the disc onto the LIAISON® MDX.
Run
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.
Simplexa® COVID-19/ Flu A/B & RSV Direct ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa® COVID-19/ Flu A/B & RSV Direct |
24 |
IVD |
MOL4450 |
|
Simplexa® COVID-19/ Flu A/B & RSV Direct Positive Control Pack |
10 |
IVD |
MOL4460 |