Simplexa™ COVID-19 Direct
A proven tool in the pandemic and now established for long-term SARS-CoV-2 detection
Amongst the first FDA-cleared real-time RT-PCR assays delivering the standard for rapid and accurate detection of SARS-CoV-2 from suspected COVID-19 symptomatic individuals.
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Disease state
The SARS-CoV-2 virus outbreak was declared a global COVID-19 pandemic on March 11, 2020, by the World Health Organization (WHO). Since then, more than 760 million people have been infected, and nearly 7 million deaths.
Over 13 Billion COVID-19 vaccines have been administered globally, but the pandemic is not officially over. Vaccinated individuals contract less severe disease but can transmit infections and are potentially susceptible to infection from new SARS-CoV-2 variants. COVID-19 causes mild to moderate respiratory pathology in all ages, more severe in the elderly, immunocompromised, and people with underlying medical conditions. Symptoms of COVID-19 are similar to the common cold and flu, but its more contagious nature affects epidemiological and clinical outcomes.
The goal is to transition to a manageable endemic disease state requiring effective diagnostics to detect, trace, and isolate or treat.
SARS-CoV-2 is a persistent global health problem
The value of Simplexa™ COVID-19 Direct
FDA-cleared for reliable testing of SAR-CoV-2 beyond the pandemic
Impactful since the pandemic beginnings
The proven EUA assay formulation and instrumentation are now FDA-cleared with a higher threshold for robust and accurate SARS-CoV-2 detection for any clinical lab.
COVID-19 testing simplified and proven
Easy to use sample-to-answer system with no extraction and all-in-one reagents for use with common nasal & nasopharyngeal swab samples.
Reliable SARS-CoV-2 detection
Targets two regions of the SARS-CoV-2 genome to provide high sensitivity and help prevent false negatives.
Flexible differential diagnosis
Test the patient sample in the same run with Simplexa™ Flu A/B & RSV Direct Gen II for COVID-19, Flu & RSV differentiation.
Powerful clinical utility
Excellent sensitivity and specificity with over 98% positive percent agreement and 99.6% negative percent agreement, respectively (all samples).
How Simplexa™ COVID-19 Direct works
Simplexa™ COVID-19 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™ COVID-19 Direct is compatible with the Simplexa™ Flu A/B & RSV Gen II Direct Gen in the same run. View PCR curves and QC Charts, Interface with LIS, and even during run access software.
Simplexa™ COVID-19 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™ COVID-19 Direct ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa™ COVID-19 Direct |
24 |
IVD | MOL4150 |
|
Simplexa™ COVID-19 Positive Control Pack |
10 |
IVD | MOL4160 |