Coronavirus (COVID-19) Research Testing Solutions

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 Testing Solutions

Whether you’re looking for targeted SARS‑CoV‑2 detection or a comprehensive panel of respiratory pathogens that includes SARS‑CoV‑2—we’ve got you covered. Additionally, if your lab needs custom testing, Luminex has LDT tools* that can be used with the US CDC and WHO primer sequences to detect SARS‑CoV‑2, enabling you to develop your own LDTs on the sample-to-answer ARIES® System. Using this approach, labs across the world have already validated their own ARIES®-based multi-target tests.^†

Click here to view a summary of the in silico analysis we performed to determine the ability of our currently available molecular assays to detect variant SARS-CoV-2 strains.

Targeted

Directly test for SARS‑CoV‑2 in a variety of respiratory samples. This test, based on nucleic acid amplification, accommodates variable sample throughput—test a single sample per run, or up to 12 samples at a time.

Sample-to-Answer Testing

Panels

Our panels quickly identify multiple respiratory pathogens, including the most relevant circulating pathogen today, SARS‑CoV‑2. The composition of each panel is unique, enabling you to select the test that is most suitable for your needs.

High-Throughput Testing

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

^†A Behind-the-Scenes Look at COVID-19 Testing at the Carl-Thiem-Klinikum (CTK) Hospital in Cottbus, Germany (White Paper)

Serology Assay Solutions

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 or plasma samples.

xMAP® SARS-CoV-2 Multi-Antigen Antibody Assay

The xMAP® SARS-CoV-2 Multi-Antigen IgG Assay (available for EUA and RUO) is a multiplex, microsphere-based assay that detects the presence or absence of antibodies against three different SARS-CoV-2 antigens.

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Guava® SARS-CoV-2 Multi-Antigen Antibody Kit

The Guava® SARS-CoV-2 Multi-Antigen Antibody Kit (RUO) is a novel, bead-based immunoassay for flow cytometry that detects IgG, IgM, and IgA antibodies in parallel against three SARS-CoV-2 antigens from serum and plasma samples.

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Custom Multiplex COVID-19 Serology Assays

Serology tests, when processing 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 guidance. 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. This ability to detect 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. 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.

(EUA) In Vitro Diagnostic Use Under Emergency Use Authorization. This test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories.
(RUO) This product is for Research Use Only. Not for use in diagnostic procedures.
Please contact Luminex support@luminexcorp.com to obtain the appropriate product information for your country of residence.

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 for Cellular Analysis

Flow Cytometry Systems
Product Name	Description
Guava® Muse® Cell Analyzer	A powerful, compact system that uses innovative Guava microcapillary technology to provide quick and accurate absolute cell counts, as well as information on viability and basic cell health analyses.
Guava® easyCyte™ System	A versatile benchtop platform for multi-dimensional immunophenotyping and cell health assessment. Cellular analysis provides critical information on the immune status, offering key insights into understanding immune response mechanisms.
Amnis® CellStream® Flow Cytometer	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.
Amnis® ImageStream®^X Mk II Imaging Flow Cytometer	This 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.

Flow Cytometry Kits
Product Name	Data Provided	Sample Type	Platform
Muse® Count & Viability Kit	Absolute cell count and viability	Cultured mammalian cells	Guava® Muse® Cell Analyzer
Guava® ViaCount Kit	Absolute cell count and viability	Cultured mammalian cells	Guava® easyCyte™ Systems
Muse® Human CD4 T Cell Kit	Concentration and percentages of CD4+ T cells and lymphocytes	Human whole blood or peripheral blood mononuclear cells (PBMCs)	Guava® Muse® Cell Analyzer or Guava® easyCyte™ Systems
Muse® Human CD8 T Cell Kit	Concentration and percentages of CD8+ T cells and lymphocytes	Human whole blood or peripheral blood mononuclear cells (PBMCs)	Guava® Muse® Cell Analyzer or Guava® easyCyte™ Systems
Muse® Human B Cell Kit	Concentration and percentages of B cells and lymphocytes	Human whole blood or peripheral blood mononuclear cells (PBMCs)	Guava® Muse® Cell Analyzer or Guava® easyCyte™ Systems

Explore the resources below to learn how our automated, flexible, 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

Applications of Flow Cytometry and Imaging Flow Cytometry to COVID-19 Research (Webinar)

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

For Research Use Only. Not for use in diagnostic procedures. Please contact support@luminexcorp.com to obtain the appropriate product information for your country of residence.

SARS-CoV-2 Immune Response

As scientists and clinicians race to understand COVID-19 pathogenesis and progression, as well as identify treatments for patients with this disease, one biological response has proven key to determining which patients have the most severe cases: the cytokine storm.

xMAP® multiplexing technology is already being used to analyze biomarkers associated with the cytokine storm.

This response, known clinically as “cytokine release syndrome,” occurs when the body’s immune response to a pathogen gets out of control. Cytokines are the protein flares thrown out by macrophages to let the immune system know that an intruder has been detected. In a normal response, these cytokines recruit immune cells to the pathogen to fight off infection.

In the case of SARS-CoV-2—the virus responsible for COVID-19—a certain group of patients instead experience a dramatic overreaction of cytokines, triggering symptoms including lung damage, persistent fever, respiratory distress, and multi-organ failure. The immune system’s uncontrolled response can be even more even more deadly than the virus.

People experiencing a cytokine storm need intensive clinical care, so it’s important to identify them as soon as possible. Multiplex detection of key biomarkers indicative of the cytokine response provides a rapid, customizable approach to spot a cytokine storm. These biomarkers include interferons, TNF-alpha, MCP-1 (CCL2), IL-1 beta, and IL-6.^1-3

xMAP is a microsphere-based suspension array technology that enables the analysis of multiple targets in a single reaction, which expands the capacity to look at multiple biomarkers with reduced sample usage. xMAP multiplexing technology supports both immunoassay (including serological) and molecular assay chemistries.

Luminex’s research partners have already developed several kits that can be used to detect cytokine storm. These kits have been reported in a number of papers, listed below.

References:

Shi Y, Wang Y, Shao C, et al. COVID-19 infection: the perspectives on immune responses. Cell Death Differ. 2020. 27(5):1451-1454. Available from: https://pubmed.ncbi.nlm.nih.gov/32205856/.
Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020. 395(10223):497-506. Available from: https://www.ncbi.nlm.nih.gov/pubmed/31986264.
Iannaccone G, Scacciavillani R, Del Buono M, et al. Weathering the Cytokine Storm in COVID-19: Therapeutic Implications. Cardiorenal Med. 2020. Available from: https://doi.org/10.1159/000509483.