Madison, WI USA. (August 11, 2020)
Promega Corporation today 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.
To learn more about the Lumit™ Dx SARS-CoV-2 Immunoassay visit: https://www.promega.com/products/clinical-laboratory-products/covid-19-antibody-test-kits/lumit-dx-sars-cov-2-immunoassay/