Covid19_LndPg_bnr.Flex.v1 3

 

 

In response to the global outbreak of the novel coronavirus disease (COVID-19), Luminex has developed multiple solutions to enhance our NxTAG® and ARIES® offerings in order to automate and facilitate the detection of coronavirus.

As a high-throughput, more comprehensive option for high-complexity labs, we have developed the NxTAG® CoV Extended Panel, which can detect SARS-CoV-2, and have received Emergency Use Authorization (EUA) from the US FDA and Medical Device Authorization for Importation or Sale for Health Canada.

The NxTAG® CoV Extended Panel was developed for use on the MAGPIX® System, and offers:

  • A highly scalable, cost-effective solution that can process up to 96 samples in approximately 4 hours.
  • SARS-CoV-2 detection using three viral genes (ORF1ab, E gene, and N gene), enabling sensitive and reliable results.
  • The flexibility to run tests in any combination—use the NxTAG CoV panel as a standalone test to detect
    SARS-CoV-2, detect 20 other common respiratory pathogens with the NxTAG® Respiratory Pathogen Panel (RPP), or run both tests in parallel for a complete picture of a patient’s respiratory health.

 

For more targeted coronavirus testing in moderate-complexity labs, the ARIES® SARS-CoV-2 Assay is a sample-to-answer test that detects SARS-CoV-2 in nasopharyngeal swabs, and now has received an EUA from the FDA.

The ARIES® SARS-CoV-2 Assay offers:

  • Precise Results: A moderate-complexity, sample-to-answer test that enables targeted SARS-CoV-2 detection.
  • Fast Turnaround Time: Minimal hands-on time and an automated workflow delivers results in about 2 hours.
  • Robust Detection: Exonuclease-sensitive probes for the ORF1ab and N viral genes provide superior specificity.

Additionally, Luminex has LDT tools1 that can be used with the latest US CDC and WHO primer sequences to detect SARS-CoV-2, enabling users to develop their own LDTs on the ARIES® sample-to-answer system. Using this approach, labs have already validated their own ARIES®-based, multi-target tests.

SARS-COVID-2 White Paper

A targeted SARS-CoV-2 LDT testing strategy using the ARIES® System offers:

  • Lab-specific testing, including the ability to develop a targeted test for SARS-CoV-2 detection.
  • Customized workflows, allowing users to develop, validate, and automate assays under the recently released EUA path.

 

Watch this video to see how to run the ARIES® SARS-CoV-2 Assay:

 

Related Links

To learn more about Luminex's SARS-CoV-2 solutions outside of the US, please check our regional websites (EMEA, Japan, China).

Serology assay development utilizing Luminex's xMAP multiplexing technology for COVID-19, click here.

 


Coronavirus (COVID-19) Press Releases

Luminex Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay
to Detect Virus Responsible for COVID-19 Disease
- April 6th

Luminex Receives BARDA Contract to Support Development of Second, Rapid SARS-CoV-2 Test - March 31st

Luminex Receives FDA Emergency Use Authorization for NxTAG® CoV Extended
Panel to Detect the SARS-CoV-2 Virus that Causes COVID-19 Disease
- March 27th

Luminex Provides Update on SARS-CoV-2 Validation Testing Efforts - March 13th

Luminex Provides Updates on Critical Efforts Related to Novel Coronavirus - March 4th


Speak with a Sales Representative

 

 

The NxTAG® CoV Extended Panel and the ARIES® SARS-CoV-2 Assay are for clinical use under the FDA's Emergency Use Authorization. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.

The NxTAG® CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have not been FDA cleared or approved. They have been authorized by the FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The NxTAG CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, approximately 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay). Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.

1Luminex does not endorse any specific LDT. Performance characteristics of Laboratory Developed Tests are determined by the laboratory.

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