BARDA and Luminex Corporation enter into a public-private partnership to develop an advanced serology test for use during the COVID-19 pandemic

23 Sept 2020
Tom Casburn
Associate Editor

BARDA and Luminex Corporation entered into a partnership to develop a cost-effective, high throughput test that assesses the level of neutralizing antibodies in plasma.

This advanced serology effort builds on the Emergency Use Authorized (EUA) xMAP® SARS-CoV-2 Multi-Antigen IgG assay, which is a multiplex, microsphere-based, highly sensitive and specific assay that detects the presence of antibodies against three different SARS-CoV-2 antigens. This current test determines if a patient has previously had a COVID-19 infection.

While the immune response to a past COVID-19 infection may protect against reinfection, an important aspect of understanding this potential protection is neutralization activity, or the ability of antibodies to bind with and prevent SARS-CoV-2 from interacting with human cells. Current methods of determining neutralization activity are time-consuming, expensive, and not available for the clinical setting.

To make estimates of neutralization more broadly available to healthcare professionals, Luminex is modifying the xMAP® SARS-CoV-2 Multi-Antigen IgG test. The team will compare the type and quantity of antibodies against three viral antigens – the spike protein, nucleocapsid, and receptor-binding domain – to the current “gold standard” measures of neutralization activity.

The new test will run on the MAGPIX®, Luminex 200™, and FLEXMAP 3D® platforms. Having multiple diagnostic platforms available for COVID-19 testing provides patients, healthcare providers, and public health officials with reliable information to limit transmission of the virus, treat infections and save lives.

Upon successful development, the company will seek Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.

This award is one component of BARDA’s Rapidly-Expanding COVID-19 medical countermeasure portfolio.

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xMAP® SARS-CoV-2 Multi-Antigen IgG Assay (RUO)

Luminex

The xMAP® SARS-CoV-2 Multi-Antigen IgG Assay is a serological, multiplexed microsphere-based assay to measure the presence of IgG antibodies directed against the nucleocapsid protein (N), Receptor-Binding Domain (RBD) of the spike protein, and the S1 subunit of the spike protein (S1) of SARS-CoV-2 in human serum or plasma. The xMAP SARS-CoV-2 Multi-Antigen IgG Assay features: Broad Coverage: Detects IgG antibodies against 3 SARS-CoV-2 antigens, providing comprehensive results: S1 subunit of the spike protein Receptor Binding Domain (RBD) of the spike protein Nucleocapsid protein Flexible Throughput: Test up to 96 samples per run in less than 3 hours to meet your throughput needs. Versatile System Options: Can be used on MAGPIX®, Luminex® 200™, and FLEXMAP 3D® Systems, so you can use the platform that best fits your lab. Common Sample Types: Designed for use with plasma and serum samples, eliminating the need to implement additional collection protocols. For Research Use Only.  Not for use in diagnostic procedures.  

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FLEXMAP 3D® Multiplexing Instrument

Luminex

The FLEXMAP 3D® detects up to 500 protein or nucleic acid analytes from a single aliquot of sample in a single reaction well, enabling you to generate more data while saving sample, time, and reagents.  Fast read time, compatibility with both 96- and 384-well plates, and ease of integration with front-end automation systems make the FLEXMAP 3D the platform of choice for high-throughput bioassay applications. The xMAP® multiplexing platform is composed of an instrument and associated reagents: The FLEXMAP 3D® instrument is based on the principles of flow cytometry, which integrates key xMAP detection components such as lasers, optics, fluidics and high-speed digital signal processors. xMAP microspheres are a family of 500 fluorescently dyed carboxylated polystyrene microspheres that act as both the surface for the solution phase assay and the spectral identifier that the instrument detects. The open architecture of xMAP Technology enables users to build custom multiplex assays or select from a broad menu commercially available kits. Instrument Details: Multiplex Capacity: 500 Microtiter Plate: 96 well and 384 well Throughput: ~ 20 min/96-well plate (up to 144,000 tests/hour); ~ 75 mins/384-well plate (up to 153,600 tests/hour) Dynamic Range: 4.5 logs Sensitivity:  Detects a minimum of 500 fluorochromes of phycoerythrin (PE) per xMAP microsphere Optics: Lasers/APDs/PMTs Hardware: Flow Cytometry based with dual sample fluidics paths and rapid sampling rate Software: xPONENT® Software offers interfacing options for front-end automation platforms and Laboratory Information Systems (LIS) Dimensions: 23” W x 25.7” D x 18” H (58.4 cm W x 65.3 cm D x 45.7 cm H) Weight: Up to 91 kg (200 lbs), including the instrument, monitor arm, monitor, and accessories, such as the keyboard, mouse and barcode scanner xMAP Reagent Compatibility: Magnetic and nonmagnetic microspheres

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Luminex® 200™Multiplexing Instrument

Luminex

The Luminex® 200™ detects up to 100 protein or nucleic acid analytes from a single aliquot of sample in a single reaction well, enabling you to generate more data while saving sample, time, and reagents. With more than 11,000 units sold globally to date, the Luminex 100/200 is the established standard in multiplexing instrumentation. The xMAP® multiplexing platform is composed of an instrument and associated reagents: The Luminex 200 instrument is based on the principles of flow cytometry, which integrates key xMAP detection components such as lasers, optics, fluidics, and high-speed digital signal processors. xMAP microspheres are a family of fluorescently dyed carboxylated polystyrene microspheres that act as both the surface for the solution phase assay and the spectral identifier that the instrument detects. The open architecture of xMAP Technology enables users to build custom multiplex assays or select from a broad menu commercially available kits. Instrument Details: Multiplex Capacity: Up to 100 non-magnetic; 80 magnetic Microtiter Plate: 96 well Throughput: ~40 min/96-well plate (up to 12,800 tests per hour) Dynamic Range: 3.5 logs Sensitivity: Detects a minimum of 1,000 fluorochromes of phycoerythrin (PE) per xMAP microsphere Optics: Lasers/APDs/PMTs Hardware: Flow Cytometry based Software: xPONENT® Software supports protocol-based data acquisition with robust data regression analysis Dimensions: All components combined (Analyzer, XY Platform and Sheath Delivery System) 26.5" W x 23.5" D x 12.5" H (67.3 cm W x 59.7 cm D x 31.8 cm H) Weight: All components combined (Analyzer, XY Platform and Sheath Delivery System) 113 lbs (49 kg) xMAP Reagent Compatibility: Magnetic and nonmagnetic microspheres

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