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. 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.
Intuitive 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
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 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 |