When it comes to coronavirus, we have flexible solutions for your testing and research needs.
In response to the global outbreak of the novel coronavirus disease (COVID-19), Luminex has developed multiple solutions to enhance our offerings in order to automate and facilitate the detection of SARS-CoV-2 and COVID-19 research.
Molecular SARS-CoV-2 Testing Solutions
NxTAG® CoV Extended Panel
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® NxTAG-enabled System, and offers:
- SARS-CoV-2 detection using three viral genes (ORF1ab, E gene, and N gene), enabling accurate, reliable results.
- A highly scalable, cost-effective solution that can process up to 96 samples in approximately 4 hours.
- 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.
ARIES® SARS-CoV-2 Assay
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 deliver 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.
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:
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 [email protected] 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.
- Luminex does not endorse any specific LDT. Performance characteristics of Laboratory Developed Tests are determined by the laboratory.
Serology tests are part of the second phase of the testing paradigm, which is the identification of the presence of antibodies against SARS-CoV-2 in serum.
xMAP® SARS-CoV-2 Antibody Assay
In these uncertain times, laboratories need to have confidence in COVID-19 antibody test results—which is why Luminex has developed a comprehensive SARS-CoV-2 antibody assay. Using a combination of robust internal controls and highly-specific antigens, the xMAP® SARS-CoV-2 assay enables the rapid and reliable detection of SARS-CoV-2 antibodies in plasma or serum samples.
Learn more about our xMAP SARS-CoV-2 antibody assay.
Custom Multiplex COVID-19 Serology Assays
Serology tests, when used on human samples, are used to define the population that has been infected with the virus and developed an immunological response—as seen via the antibodies in their bloodstream against the virus. This information can be helpful for disease characterization, vaccine and drug development, as well as public health policy development. xMAP® multiplexing technology is ideally suited for the development of serological assays because it supports this key antibody detection chemistry and provides a flexible, high-throughput solution.
xMAP is a microsphere-based suspension array technology that enables the analysis of multiple targets in a single reaction, expanding the capacity to look at multiple biomarkers with reduced sample usage. Leveraging the ability to multiplex the detection of antibodies against multiple antigens of an infectious agent provides rapid and detailed information about the immune status of an individual.
Further, xMAP multiplexing technology supports both protein- (capture sandwich, indirect, competitive) and nucleic acid- (direct hybridization, OLA, ASPE, microRNA) based assay chemistries, the latter of which is used in our NxTAG® CoV Extended Panel, which is currently available as an EUA diagnostic tool* using nasopharyngeal swab (NPS) samples.
As COVID-19 assay development progresses, applications of xMAP-based assays will include:
- Immune response monitoring: tracking disease progression, mapping individual antibody expression, understanding individual and population immunity, determining previous exposure, understanding duration of protective antibodies, and selecting time points for treatments.
- Pathogen identification and immune surveillance: tracking transmission rates, transmission methods, and co-infections.
- Vaccine development: selecting antigen candidates, efficacy, immunogenicity, participant selection, and vaccine QC/QA testing for product release.
- Drug development: screening candidate compounds for further investigation, PK/PD, screening patients for clinical trials, and screening convalescent plasma.
- Public health and epidemiology: tracking global transmission, identifying zoonotic reservoirs, and transmission modeling in surrogate species.
- Cytokine storm: cytokine profiling to inform treatment, clinical progression, and inflammation management.
- Immunogenetics: HLA type correlation with clinical outcomes, HLA type informed treatment decisions, and donor-recipient matching.
- Screening: Screening for high-risk personnel, military, healthcare, the travel industry, food suppliers, mail/delivery drivers, and biological donations.
* The NxTAG® CoV Extended Panel is for clinical use under the FDA’s Emergency Use Authorization. Please contact Luminex [email protected] to obtain the appropriate product information for your country of residence.
* The NxTAG® CoV Extended Panel has not been FDA cleared or approved. It has 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. This test is 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.
Applications of Flow Cytometry in COVID-19 Research
The rapid spread of SARS-CoV-2 and the COVID-19 pandemic have underscored an urgent need to understand the mechanisms of infection, including the host immune response. COVID-19 research is being performed on the molecular, protein, and cellular levels in many different environments to devise strategies and therapeutics for mitigating the spread and impact of this strain of coronavirus.
Flow cytometry is a powerful analytical method that can be a valuable tool for many areas of COVID-19 research. Our Guava® and Amnis® systems give you instant access to all facets of cellular phenotypes and morphology, providing a comprehensive picture of the cellular immune response to COVID-19.
Luminex Flow Cytometry Systems:
The Guava® Muse® Cell Analyzer is a powerful, compact system that uses innovative Guava microcapillary technology to provide quick and accurate absolute cell counts, viability, and basic cell health analyses.
The Amnis® CellStream® Flow Cytometer is an easy-to-use, compact benchtop system that offers high-sensitivity, precise detection of viral particles. The flexible, modular design of the CellStream System allows the platform to easily grow with your evolving research needs.
The Amnis® ImageStream®X Mk II Imaging Flow Cytometer offers high-end detection of viral particles, which includes acquisition of image data. Along with high-powered lasers, the new High Gain mode for the ImageStream System delivers increased sensitivity for detecting small particles.
Explore the resources below to learn how our automated, flexible, and easy-to-use flow cytometers can help accelerate discovery in your COVID-19 research.
- Applications of Flow Cytometry in COVID-19 Research – Flyer
- Analysis of Viral Particles on Amnis Flow Cytometers – Poster
- Enabling COVID-19 Research with Simplified T/B Cell and PBMC Characterization – Poster
- Solutions for COVID-19 Research Using Multiparametric Microcapillary Flow Cytometry – Poster
Coronavirus (COVID-19) Press Releases:
ARIES® SARS-CoV-2 Assay (EUA-IVD) – Sales Sheet
NxTAG® CoV Extended Panel (EUA-IVD) – Sales Sheet
xMAP® SARS-CoV-2 Multi-Antigen IgG Assay (RUO) – Sales Sheet
Speak with a Sales Representative