Simplexa® Influenza A H5N1 Direct
The detection of all H5N1 strains in nasal and nasopharyngeal swab specimens with a recent positive flu A test.
The Diasorin Molecular Simplexa® Influenza A H5N1 Direct kit is a Research Use Only (RUO) assay intended for the discrimination of all H5N1 strains in nasal and nasopharyngeal swab specimens from human patients with a recent positive flu A test. The assay supports the understanding of strain epidemiology for Research Use Only. Not for use in diagnostic procedures.
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Disease state
Highly pathogenic avian influenza (HPAI) is a severe and highly contagious disease of poultry caused by avian influenza A viruses, most commonly subtypes H5 and H7, and is commonly referred to as avian or bird flu. HPAI viruses can be transmitted from wild birds to domestic poultry and may also infect other avian and animal species. Although avian influenza viruses do not typically infect humans, sporadic human infections have been reported. Importantly, the term "highly pathogenic" describes the severity of disease in birds and does not necessarily indicate increased pathogenicity in humans.
The value of Simplexa® Influenza A H5N1 Direct
Fast time-to-result
Easy-to-use sample-to-answer system with no RNA extraction required, and all-in-one reagents for use on nasal and nasopharyngeal swabs with results in 90 minutes.
Meets the needs of the evolving respiratory landscape
This RT-PCR assay enables the detection of all H5N1 strains in nasal and nasopharyngeal swab specimens from human patients with a recent positive flu A test. The assay supports the understanding of strain epidemiology for Research Use Only. Not for use in diagnostic procedures.
How Simplexa® Influenza A H5N1 Direct works
The Simplexa® Influenza A H5N1 Direct is a qualitative real-time RT-PCR assay designed for research use. It features a streamlined workflow that enables direct use of unextracted primary samples with ready-to-use PCR reagents, and runs on a reusable Direct Amplification Disc using the compact LIAISON® MDX system, offering operational simplicity, flexibility, and high-quality performance.
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 approximately 90 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 run.
Simplexa® Influenza A H5N1 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
Run
- 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 comes in a compact footprint measuring only 12″ by 8″ by 12″, so that it can fit into laboratories of any size.
Simplexa® Influenza A H5N1 Direct ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa® Influenza A H5N1 Direct |
24 |
RUO |
MOL4370 |
|
Simplexa® Influenza A H5N1 Direct Positive Control Pack |
10 |
RUO |
MOL4380 |