The Abbott Alinity m SARS-CoV-2 Assay: A Crucial Tool for COVID-19 Testing

February 20, 2024

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The Abbott Alinity m SARS-CoV-2 assay has become an essential part of COVID-19 testing globally. This polymerase chain reaction (PCR) based test allows for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19. With its high sensitivity and specificity, quick turnaround time, and ability to run high volumes of tests, the Alinity m SARS-CoV-2 test has supported population-scale testing during the pandemic.

An Overview of the Alinity m Platform

The Abbott Alinity m system is an automated molecular diagnostics platform capable of performing sample preparation, amplification, detection, and result calculation for a variety of infectious disease tests.

Key features of the Alinity m platform include:

  • Fully automated sample-to-result workflow
  • Random access for stat testing capabilities
  • Onboard capability for up to 3 assays simultaneously
  • High throughput with ability to run up to 1,080 tests in a 24 hour period

The Alinity m leverages Abbott’s sensitive polymerase chain reaction (PCR) technology to deliver molecular test results. This makes it well-suited for infectious disease testing where detection of a pathogen’s genetic material is required.



Development of the Alinity m SARS-CoV-2 Assay

In early 2020, Abbott fast-tracked the development of a molecular diagnostic test to detect the novel coronavirus SARS-CoV-2 on its Alinity m platform.

The Alinity m SARS-CoV-2 assay received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in March 2020 at the very start of the pandemic. This allowed early adoption and use of this test across Abbott’s installed base of Alinity m analyzers.

Abbott designed the Alinity m SARS-CoV-2 test to target conserved regions of the SARS-CoV-2 genome, making it resilient to viral mutations. The company also maximized test sensitivity to ensure detection of both symptomatic and asymptomatic COVID-19 cases.

Performance and Validation

Multiple analytical and clinical validation studies have shown excellent performance of the Alinity m SARS-CoV-2 amp kit:

  • >99% sensitivity and specificity for qualitative detection of SARS-CoV-2
  • 95% positive agreement and 100% negative agreement versus an EUA RT-PCR comparator method
  • Limit of detection (LoD) down to around 120 GFP/mL, allowing sensitive detection at low viral loads
  • Turnaround time under 2 hours

The high accuracy and reliability of the Abbott test has supported its widespread adoption globally. Over 500 million Alinity SARS-CoV-2 tests have been conducted to date.

Real-World Usage and Applications

The Alinity m SARS-CoV-2 assay has served critical public health needs during the COVID-19 pandemic:

Population Screening and Surveillance

With its quick turnaround time and ability to run over 1,000 tests per day, the Alinity assay has proven invaluable for large-scale population screening and disease surveillance programs. This has been useful for tracking infection rates and detecting new outbreaks.

Diagnosing Individuals

Its excellent clinical sensitivity and specificity also make the Alinity m SARS-CoV-2 test well-suited for diagnosing COVID-19 in symptomatic patients presenting to healthcare settings.

Monitoring Hospitalized Patients

Finally, the test can be used to monitor COVID-19 progression and response to treatment in hospitalized patients when used for periodic re-testing.


Comparisons to Other COVID Tests

The Abbott Alinity assay offers advantages over other methods for detecting SARS-CoV-2:

Compared to rapid antigen tests

  • More sensitive due to amplification of viral genetic material
  • Better for detecting early and asymptomatic infections

Compared to other PCR tests

  • Fully automated versus manual workflow
  • Higher throughput enabling mass testing
  • Quicker time-to-result

Supply and Logistics Considerations

With over 2,000 Alinity m analyzers installed globally, Abbott scaled up production capacity of the SARS-CoV-2 test kits to meet demand during the pandemic. This helped ensure continuity of testing with:

  • Ramp up to produce over 50 million tests per month
  • Shipping of test kits to over 170 countries worldwide
  • Strict quality control and monitoring procedures

Recent Issues and Developments

In September 2021, the FDA alerted laboratories and healthcare providers about an increased risk of false positive results with certain lots of the Alinity SARS-CoV-2 test kits:

The issue stemmed from contamination of a reagent used in the assay. Abbott recalled the affected kits and put additional controls in place to prevent reoccurrence.

The quick action prevented major disruption, demonstrating Abbott’s strong quality management procedures. Abbott continues working to expand features and claims for its industry-leading SARS-CoV-2 test.


Frequently Asked Questions

What is the Alinity m SARS-CoV-2 test used for?

The Alinity m SARS-CoV-2 assay allows for qualitative detection of SARS-CoV-2 viral RNA extracted from patient respiratory specimens like nasal or throat swabs. It is used as an aid in diagnosing current COVID-19 infection in individuals suspected of having the disease based on signs/symptoms or other risk factors.

The test has also been useful for COVID-19 screening and surveillance testing of broader populations to monitor infection rates and trends.

How long does it take to get Alinity m SARS-CoV-2 test results?

One major advantage of the Alinity assay is its quick turnaround time. The system automates and streamlines the entire molecular testing workflow from sample-to-result.

Most test results are available in under 2 hours. This allows patients and physicians to make timely decisions around treatment and isolation precautions based on status of infection.

Can the Alinity m SARS-CoV-2 assay detect Omicron or other variants?

Yes, the Alinity test targets highly conserved regions of the SARS-CoV-2 genome, making it resilient to viral mutations. Validation data has confirmed detection of all major variants of concern including Alpha, Beta, Gamma Delta, and Omicron strains.

Regular reassessment also allows the test to be updated if any future variants emerge that potentially impact sensitivity.

What sample types can be used?

The Alinity m SARS-CoV-2 assay is validated for use with common SARS-CoV-2 respiratory specimens:

  • Nasal swabs
  • Nasopharyngeal swabs
  • Oropharyngeal swabs
  • Nasal washes/aspirates
  • Sputum

Nasopharyngeal and nasal swabs are the most commonly used sample types with this test.

Can patients get tested at home using the Alinity assay?

No, the Abbott Alinity m platform is designed for use by trained staff in professional laboratory environments. It requires venipuncture collection of blood samples along with handling of other infectious specimens.

So testing must occur in a clinical setting under proper safety protocols rather than in a home environment. However, patients can get tested quickly and conveniently at one of thousands of sites worldwide that offer the Alinity SARS-CoV-2 assay service.


Key Takeaways

  • The Abbott Alinity m SARS-CoV-2 assay provides highly accurate, qualitative detection of SARS-CoV-2, the virus causing COVID-19
  • Fully automated sample-to-result workflow provides quick turnaround time under 2 hours
  • Widely adopted globally with over 500 million tests conducted to date
  • Proven capability for high volume population screening and surveillance efforts
  • Robust supply chain supports continued access to testing

I aimed to provide an informative overview of the key features, validation data, applications, and supply considerations for the Alinity SARS-CoV-2 test. Please let me know if you need any sections expanded or have additional questions!

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