Simplexa™ Group A Strep Direct Kit
Fast, flexible and accurate Group A Strep testing
Differentiate cases rapidly from more prominent viral pharyngitis to prevent over-use of antibiotics by rapidly detecting Group A Strep accounting for 20 - 30% of pharyngitis.
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Disease state
Group A Streptococcus is responsible for common infections, such as strep throat, and may cause up to 30% of acute pharyngitis cases in children and up to 20% of cases in adults. Patients may present with symptoms that overlap extensively with other infectious diseases, which makes diagnosis difficult when based solely on clinical observation.
The benefits of quality molecular testing continue to gain momentum as an alternative to culture and rapid antigen testing as they provide definitive answers without supplemental testing.
Definitive answers with Molecuar Diagnostics
The value of Simplexa™ Group A Strep Direct
Faster diagnosis for better patient outcomes
Simple workflow
Easy to use CLIA moderate complexity workflow with primary sample and all-in-one reagents for use on throat swabs.
Fast time-to-result
Improved efficiency with a true sample-to-answer workflow with results in 60 minutes.
Confidence in your results
In over 1,300 prospective samples, the assay demonstrated high performance with excellent clinical agreement (97.4% PPA and 95.2% NPA) against culture.
How Simplexa™ Group A Strep Direct works
Simplexa™ Group A Strep Direct is an in-vitro qualitative real-time 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 60 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™ Group A Strep Direct Kit and Simplexa™ Group B Strep Direct may be used in the same run: view PCR curves and QC Charts, Interface with LIS, and even during run access software.
Simplexa™ Group A Strep 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
Scanning
- 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
Loading
In each Disc Wedge:
- Load 50 µL of sample
- Load 50 µL of reaction mix (= 1 vial content)
- Close the foil and remove the tab
- Disc may be re-used up to 8 times (until all Wedges are utilized)
- Close the foil and remove the tab
Load and run
Load the disc onto the LIAISON® MDX and start the run. The results and a final report are automatically generated by the software.
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™ Group A Strep Direct ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa™ Group A Strep Direct |
24 |
IVD | MOL2850 |
|
Simplexa™ Group A Strep Direct Positive Control Pack |
10 |
IVD | MOL2860 |