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™ COVID-19 & Flu A/B Directs 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.
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.
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.
Simplexa™ COVID-19 & Flu A/B Directs 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
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.
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 |