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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.

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.



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.

Indications for Simplexa® COVID-19 Direct use

Assay and system

A real-time RT-PCR assay run on  LIAISON® MDX  to detect of SARS-CoV-2

Patient types

Symptomatic individual suspected of COVID-19 by healthcare provider

Diagnostic lab

Hospital, Commercial, Reference and Public Health laboratories

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 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


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.

Molecular Diagnostic Tool LIAISON® Mdx - Diasorin


One instrument.
Multiple discs.
Ultimate Flexibility.

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Simplexa® COVID-19 Direct ordering info

Part Name
Kit Size
Registration Status
Part Number

Simplexa® COVID-19 Direct




Simplexa® COVID-19 Positive Control Pack





Diasorin document repository


Luminex document repository

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Research publications

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More details about Simplexa® COVID-19 Direct

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