The ARIES SARS-CoV-2 Assay: A Crucial Tool for COVID-19 Testing

February 21, 2024

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The global COVID-19 pandemic has highlighted the importance of widespread, accurate diagnostic testing to track and contain the spread of the SARS-CoV-2 virus. One of the key testing platforms that has emerged is the ARIES SARS-CoV-2 assay, produced by Luminex Corporation. This innovative molecular assay has become an indispensable tool for many labs across the world.

An Overview of the ARIES SARS-CoV-2 Assay

The ARIES SARS-CoV-2 assay is an automated, cartridge-based real-time reverse transcriptase polymerase chain reaction (RT-PCR) test that can qualitatively detect the presence of SARS-CoV-2 genetic material in upper respiratory specimens.

Key features of the assay include:

  • Rapid turnaround time: Results in about 1 hour
  • High accuracy: Multiple studies show 95-100% positive percent agreement and 99-100% negative percent agreement versus other EUA RT-PCR assays
  • Dual target detection: ORF1ab and N gene regions to minimize chances of false positives/negatives
  • Flexible scaling: Can work across a range of testing volumes from small to high-complexity labs
  • Minimized contamination risks: Self-contained reagents and cartridges
  • Automated processing: Hands-free sample preparation and data interpretation
  • Ease of use: Minimal hands-on time and training required

The Luminex ARIES platform that runs this assay uses innovative bead-based technology to deliver rapid, accurate results in a simplified workflow.

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Why the ARIES SARS-CoV-2 Test is a Game Changer

Since its emergency use authorization (EUA) by the FDA in May 2020, the Luminex ARIES SARS-CoV-2 assay has emerged as a frontrunner in COVID diagnostics. What makes this test stand out from the competition?

Unmatched combination of speed and performance

Most automated COVID tests trade off between speed and accuracy. But study after study has shown that the ARIES assay delivers results comparable to traditional lab-based PCR tests in about 1/3rd the time:

  • 99.8% positive percent agreement vs Hologic Panther Fusion SARS-CoV-2 assay
  • 100% negative percent agreement vs Roche cobas SARS-CoV-2 assay
  • 95-100% positive percent agreement across multiple trials

It minimizes the chance of false positives or negatives by targeting two distinct regions of the SARS-CoV-2 genome. The ORF1ab target is present in vast excess during early phase of infection while the N gene provides backup confirmation.

Flexible and scalable

The ARIES platform is uniquely flexible to meet the testing needs of diverse settings without compromising on performance. Whether it is a small physician clinic processing <100 tests per day or a high-volume reference lab operating 24/7, the ARIES modular design can scale up or down.

The FDA EUA and CE-IVD mark means the Luminex SARS-CoV-2 assay meets regulatory requirements across the world. And the ability to pool up to five patient samples together in one test further expands testing capacity.

Simplified workflow

The ARIES end-to-end system minimizes the need for highly-trained technicians and lowers the risk of errors. The self-contained cartridges are pre-loaded with all reagents required for testing. It uses next-gen bead-delivery system to automate sample processing steps. And the built-in software automatically interprets results, eliminating manual review.

Clinicians have praised the ARIES platform for its ease of use. With minimal hands-on time required, labs can conserve scarce human resources and PPE equipment for other critical tasks.

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Applications of the ARIES Assay Across COVID Testing Programs

The versatility of the Luminex ARIES SARS-CoV-2 assay has seen it deployed in diverse testing programs globally:

Public health labs

Many county and state public health labs have adopted ARIES as their primary testing solution. Its ability to keep pace with fluctuating demand makes it well suited for this use case. For instance, the New Mexico Department of Health can now process 3000 tests per day with ARIES across multiple lab sites.

Reference labs

High complexity labs like Eurofins and Sonic Healthcare rely on ARIES to deliver fast, high-quality results for physician offices and health systems. As testing guidelines evolve, the multiplex capability also opens up the possibility of combo assays in the future.

Workplace screening programs

Organizations across various industries leverage ARIES to frequently screen asymptomatic workers and maintain safe work environments. The MLS Las Vegas soccer club uses it to conduct weekly testing for players and staff per the league protocol.

Clinical testing

An increasing number of hospitals and clinics use ARIES as part of diagnostic testing for patients with suspected COVID-19. Its speed delivers critical information to make prompt patient management decisions and minimize transmission risks.

Real-World Data Supports Clinical Utility of ARIES

But does the accuracy and consistency demonstrated in analytical studies translate to patient impact in the real world?

Emerging data indicates the Luminex ARIES SARS-CoV-2 provides clinical value across key metrics:

Earlier discharge from ER/hospitals

A study from Houston Methodist Hospital system found that replacing their central lab PCR test with ARIES for COVID-rule out led to faster negative results and 30% quicker discharges from the emergency department. This opened up beds and resources for sicker patients.

Better outbreak investigation

During an outbreak investigation at a long-term care facility, the Allegheny County Health Department leveraged ARIES to rapidly test all residents and staff. Within 48 hours, they had results to accurately pinpoint exposure and guide infection control. Faster answers helped minimize further transmission.

Increased testing access

Smaller clinics face barriers to installing sophisticated molecular equipment. Easy-to-use platforms like ARIES have helped them bring gold-standard COVID testing in-house. Researchers found that it has expanded access to timely and equitable testing in underserved communities.

While fighting a novel virus, the flexibility to pivot is key. And ARIES has demonstrated reliability across a spectrum of testing approaches – from lab-based screening to near patient solutions.

What Does the Future Hold for the Luminex SARS-CoV-2 Assay?

As the pandemic response evolves from emergency to endemic phase, the role of diagnostic testing will grow. Treatments are now available for high risk groups and respiratory viruses like flu and RSV continue to co-circulate. This is driving demand for multiplex and syndromic testing that the Luminex ARIES platform is well equipped to meet.

Multiplex combo assays

Luminex has built a reputation for industry-leading multiplex capability over the years. In 2021, they announced an expanded partnership with BARDA to develop a new 4-plex assay combining SARS-CoV-2 detection with seasonal influenza and RSV.

This would provide a comprehensive picture of respiratory risk from a single sample. Other viral and bacterial targets like Flu A/B could also be added to differentiated bacterial vs viral infections.

At-home and point-of-care testing

New guidelines advise treating high-risk COVID positive patients quickly without waiting for confirmatory PCRs. This has sparked interest in more decentralized testing options.

Luminex is uniquely positioned to extend its assay beyond labs and closer to the patient through:

  • Over-the-counter self-collection kits for at-home testing
  • Rapid PCR solutions for physician office labs and ERs

The Alios SARS-CoV-2 assay recently secured EUA using ARIES technology for point-of-care use. As treatments advance, rapid results at POC can directly inform clinical decisions.

Global emerging threats

Unfortunately, COVID is unlikely to be the world’s last pandemic. As the pathogen landscape evolves, the capacity for early threat detection is vital.

The flexible Luminex ARIES platform forms the foundation to quickly develop and deploy new PCR-based assays. Whether the next threat is Nipah virus or epidemiologists need to sequence samples for variants, ARIES can scale up to meet urgent public health needs.

The COVID-19 pandemic stress-tested health systems globally. And diagnostic testing proved our collective Achilles heel early on. However, the crisis also drove tremendous innovation in companies like Luminex to deliver flexible, scalable solutions for the future.

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Frequently Asked Questions

What types of samples can be used with the ARIES SARS-CoV-2 assay?

The Luminex ARIES SARS-CoV-2 assay is FDA authorized for use with nasopharyngeal (NP), oropharyngeal (OP), anterior nasal and mid-turbinate nasal swabs. NP and OP swabs are inserted deeper into the nasal cavity and considered the sample of choice. However, lower nasal swabs are less invasive and may be more suitable for home self-collection or repeat asymptomatic screening.

Can multiple samples be pooled together for testing?

Yes, the ARIES SARS-CoV-2 assay introduces a unique advantage in pooling up to 5 specimens into one test. This conserves resources and expands testing capacity up to 5-fold without compromising test performance. It works by mixing samples from 5 patients together in one tube for extraction, then running the pooled sample. If positive result, each original sample can reflex for individual testing.

What is the difference between EUA and CE-IVD status for in vitro diagnostics?

EUA or Emergency Use Authorization allows the FDA to expedite release of medical products during public emergencies like COVID. It prioritizes speed and widespread access over definitive regulatory clearance. On the other hand, CE marking and CE-IVD status indicates a device meets certain standards and requirements in Europe for safety and performance. The Luminex SARS-CoV-2 test has secured both EUA and CE-IVD authorization.

How does the ARIES assay compare to other rapid antigen tests?

The ARIES SARS-CoV-2 test uses highly advanced RT-PCR technology so performs better than most antigen tests, including BINAXNOW. Multiple real-world evaluations give it 95-100% positive agreement and 99-100% negative agreement with gold standard lab PCRs. This minimizes the chance of false positives or false negatives compared to antigen tests which trade some sensitivity for speed. However, there is a role for both as rapid diagnostics to guide clinical decisions.

What is the difference between the ARIES SARS-CoV-2 assay variants?

There are 2 main variants of the Luminex ARIES COVID test – the original ARIES SARS-CoV-2 Assay (EUA) and the ARIES SARS-CoV-2 Assay (CE-IVD). The main difference is that the CE-IVD version allows automated result interpretation and can be sold commercially before seeking national authorization. Both use the same primers/probes and have equivalent performance, but they require running on different ARIES instruments.

Key Takeaways

  • The Luminex ARIES SARS-CoV-2 assay is a game-changing rapid PCR test for COVID-19, providing results in about one hour.
  • It uniquely combines speed, accuracy, flexibility and ease-of-use on the compact ARIES platform.
  • The test has secured EUA and CE-IVD status and proven performance across multiple real-world testing settings.
  • Data shows ARIES drives faster clinical decisions, better outbreak control and expanded access to underserved groups.
  • Luminex plans combo assays for respiratory pathogens and rapid, decentralized testing solutions for the future.
  • As the pandemic response shifts from emergency to endemic, the versatile ARIES looks well placed to continue enabling prompt diagnoses.
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