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Promega launches COVID-19 serology test: Lumit™ Dx SARS-CoV-2 Immunoassay

Promega Corp.

Workflow is quick, simple and scalable for high-throughput antibody detection with high PPA sensitivity and NPA specificity

26 Aug 2020
Tom Casburn
Associate Editor

Product news

Promega Corporation have announced the launch of its new serological antibody test for COVID-19 to detect the presence of antibodies against the SARS-CoV-2 virus. A positive result may indicate whether an individual has been exposed to, and mounted an immune response to, the virus. Promega has submitted an application to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for the antibody test.

The Promega Lumit™ Dx SARS-CoV-2 Immunoassay is an in vitro diagnostic test, which among PCR confirmed COVID-19 patients 20+ days post-symptom onset, has a sensitivity (PPA) of 93.5% when assessed with samples from patients with varying levels of disease and 100% sensitivity across hospitalized patients. The test has a specificity (NPA) of 99.4% and 97.7% when assessed with samples presumed negative for SARS-CoV-2 and samples exhibiting other illnesses, respectively.

The test utilizes the Promega NanoBiT® bioluminescence complementation technology to generate a luminescent signal that is detected on a luminescent-capable microplate reader when SARS-CoV-2 antibodies are present in a patient’s serum or plasma sample. The Lumit™ Dx SARS-CoV-2 Immunoassay uses a quick and simple workflow that is easily adaptable to most liquid handlers to accelerate testing of large patient populations. Features include:

  • Add-incubate-read format with no wash steps
  • Reliable results in less than an hour at room temperature
  • Scalable for high-throughput needs
  • Antibody detection against the RBD antigen within the SARS-CoV-2 spike (S) protein

“Specific and sensitive immunoassays are critical tools in fighting the SARS-CoV-2 pandemic, not only for informing about individual exposure but also to aid in vaccine development,” says Promega Senior Research & Development Director Poncho Meisenheimer. “Our teams took up the challenge to develop an innovative way to detect SARS-CoV-2 antibodies by applying our well-established technology and expertise in bioluminescence. We are elated to be able to offer clinical and public health labs this quick, simple and reliable approach.”

In 2015, the Promega proprietary bioluminescent NanoBiT® technology won the European Laboratory Research and Innovation Group’s Advances in Cell Based Screening in Drug Discovery Technology prize. It also made The Scientist’s list of top 10 innovations for the year. Promega has been on the leading edge of bioluminescent tool and assay development since 1990 when it launched its first biosensor technology, Luciferase, based on firefly luciferase.

Promega supplies reagents, assays and benchtop instruments essential for COVID-19 research, drug development and diagnostic testing. The company supports approximately 29 COVID-19 test kits around the world and provides sample preparation tools to 670 clinical labs globally. Since January, Promega has provided enough amplification reagents and enzymes to enable testing an estimated 350.5 million samples for SARS-CoV-2 worldwide. The Promega GoTaq® Probe 1-Step RT-qPCR System, the Maxwell® RSC 48 Instrument and the Maxwell® RSC Viral Total Nucleic Acid Purification Kit are all authorized products in the Centers for Disease Control and Prevention’s 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel for emergency use.

Promega tools used for COVID-19 applications are a small subset of the 4,000 products that Promega manufactures and distributes globally, serving research, pharma, clinical, forensic and applied markets. These tools are used for a myriad of applications in human health, disease, genetic identity, drug development, clinical diagnostics and much more.

Do you use Promega products in your lab? Write a review today for your chance to win a $400 Amazon Gift Card>>

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NanoBiT® PPI Starter Systems

Promega Corp.

NanoLuc® Binary Technology (NanoBiT) is a two-subunit system based on NanoLuc® luciferase that can be applied to the intracellular detection of protein:protein interactions (PPIs) in live cells. The NanoBiT® system is composed of two small subunits, Large BiT (LgBiT; 18kDa) and Small BiT (SmBiT; 11 amino acid peptide), that are expressed as fusions to target proteins of interest. The LgBiT and SmBiT subunits have been independently optimized for stability and minimal self-association. Interaction of the target proteins facilitates subunit complementation to give a bright, luminescent enzyme. The NanoBiT® PPI Starter Systems provide the vectors required to create the LgBiT and SmBiT protein fusions, a PRKACA:PRKAR2A constitutively interacting positive control pair and a negative control vector. Starter systems also include the Nano-Glo® Live Cell Assay System, a single-addition, non-lytic detection reagent used for monitoring NanoBiT® luminescence in living cells. The reagent is prepared by diluting the Nano-Glo® Live Cell Substrate with the Nano-Glo® LCS Dilution Buffer to make the Nano-Glo® Live Cell Reagent. Both substrate and buffer solutions are optimized to provide enhanced stability and reduce autoluminescence in the presence or absence of serum, increasing the sensitivity for detection of low levels of NanoBiT® luminescence. The FKBP:FRB pair is provided separately as an inducible positive control. Expression is driven by HSV-TK promoter, providing constitutive, low-level expression in mammalian cells. Using the NanoBiT® MCS Starter System, you can generate N- and C-terminal LgBiT and SmBiT fusions to proteins of interest using traditional cloning with a multiple cloning site (MCS). Using the NanoBiT® Flexi® Starter System, you can generate N- and C-terminal LgBiT and SmBiT fusions using the Flexi® Vector Cloning System, a directional cloning method based on two rare-cutting restriction enzymes, SgfI and PmeI, that provides a rapid, efficient and high-fidelity way to transfer protein-coding regions between Flexi® Vectors without the need to resequence. Utilize Find My Gene™ to obtain your ORF clones already in Flexi® format for simple creation of fusions.   Features: Obtain Greater Sensitivity: Bright signal and reduced background improve sensitivity, signal:background ratio and dynamic range. More Accurately Model PPI Biology: Minimize artifacts with small tags and low, natural expression levels; perform real-time kinetic analysis in live cells. Precisely Measure Interaction Dynamics: Low affinity of tags minimizes spontaneous LgBiT:SmBiT association; complementation is easily reversible allowing accurate analysis of protein association and disassociation. Perform Simple Measurement: Bright luminescent output is ideal for any luminometer with no specific filter or injector requirements. Scale Your Assays: Assays can be scaled from bench to HTS, allowing use with any plate size up to 1,536-well format; detection reagent has been optimized for benchtop stability. Applications: Real-time measurements of PPI dynamics. Single-copy or single-cell measurements of PPI. PPI modulator screens in 384- or 1536-well formats.

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.PCR and Thermal CyclingPolymerase chain reaction (PCR) kits and thermal cyclers are used for the in vitro amplification of DNA permitting subsequent analysis and experimental procedures. Explore a range of high-quality polymerase, primers and nucleotides or simplify your workflow with a PCR mastermix. Find reverse transcription PCR (RT-PCR) and cDNA synthesis kits for RNA products and libraries. Quantitatively measure the amplification of DNA with real-time PCR (qPCR) and droplet digital PCR (ddPCR) kits and systems, and discover automated PCR setup solutions to increase throughput. Alternative DNA amplification methods also include recombinase polymerase amplification (RPA) kits. Find the best PCR kits and thermal cyclers and purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.DNA / RNA Extraction and PurificationPurified DNA and RNA are required for numerous downstream molecular biology applications. Consequently, the importance of high-quality DNA/RNA extraction and purification equipment cannot be underestimated. 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Browse our peer-reviewed product directory to compare immunoassay systems, read user reviews, and get pricing directly from manufacturers.Nucleic Acid ConcentrationqPCRQuantitative PCR (qPCR) is a molecular biology technique used to amplify and measure the amount of a specific DNA or RNA target. It plays a crucial role in gene expression analysis, pathogen detection, and quantifying DNA or RNA in various applications. Real-time PCR provides precise, quantitative results and is widely used in research, diagnostics, and clinical studies. Browse our peer-reviewed product directory to find the best qPCR solutions; compare products, check reviews, and get pricing directly from manufacturers.BioluminescenceVirusesViruses are microscopic pathogens that require a host cell to replicate. Understanding their structure, replication cycle, and impact on the immune system is crucial in developing effective treatments, vaccines, and diagnostic methods. Research continues to focus on emerging viral diseases and antiviral drug discovery. Explore solutions for virus research, detection, and treatment in our peer-reviewed product directory; compare products, check customer reviews, and get pricing directly from manufacturers.CoronavirusCoronaviruses are a large family of viruses that can cause illnesses ranging from the common cold to more severe diseases like COVID-19. Research into the biology, transmission, and treatment of coronaviruses has become a global priority, particularly since the emergence of SARS-CoV-2. Understanding the virus�s structure and behavior is essential for developing vaccines, diagnostics, and antiviral treatments. Explore our peer-reviewed product directory to discover the latest research tools, diagnostic tests, vaccines, and treatments for coronavirus, compare products, read reviews, and receive pricing directly from manufacturers.Covid-19COVID-19, caused by the SARS-CoV-2 virus, has led to a global health crisis with profound impacts on societies and economies. Research into diagnostics, vaccines, treatments, and understanding viral mechanisms continues to evolve. The pandemic has accelerated innovations in healthcare and biopharmaceuticals, including novel vaccine platforms and rapid testing technologies. Browse our peer-reviewed product directory to find top COVID-19 testing kits, research tools, vaccines, and treatments, compare products, read reviews, and receive direct pricing from manufacturers.

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