The Lumit Dx SARS-CoV-2 immunoassay can be easily adapted by most liquid handlers to boost the testing of large patient populations
Promega has introduced new serological antibody test for the detection of the presence of antibodies against the SARS-CoV-2 virus.
The company has also submitted an application with the US Food and Drug Administration (FDA) to secure an emergency use authorisation (EUA) for the Promega Lumit Dx SARS-CoV-2 immunoassay
Promega’s in vitro diagnostic test is said to show a sensitivity of 93.5% when evaluated samples from patients with varying levels of disease and 100% sensitivity across hospitalised patients.
According to the company, the test showed a specificity (NPA) of 99.4% and 97.7% when evaluated samples presumed negative for SARS-CoV-2 and samples exhibiting other illnesses.
The in vitro diagnostic test uses the Promega NanoBiT bioluminescence complementation technology
The test applies the Promega NanoBiT bioluminescence complementation technology to generate a luminescent signal, which is identified 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 also uses a simple workflow, which is compliant with most liquid handlers to boost the testing of large patient populations.
Other benefits offered by the test include add-incubate-read format with no wash steps, positive results in less than an hour at room temperature, scalable for high-throughput requirements and antibody detection against the RBD antigen within the SARS-CoV-2 spike (S) protein
Promega senior research and development director Poncho Meisenheimer said: “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.
“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.”
Promega offers reagents, assays and benchtop instruments required for Covid-19 research, drug development and diagnostic testing.
The company assists around 29 Covid-19 test kits across the world, as well as provides sample preparation tools to 670 clinical labs worldwide.
Promega GoTaq Probe 1-Step RT-qPCR system, Maxwell RSC 48 instrument and Maxwell RSC viral total nucleic acid purification kit are authorised by the Centers for Disease Control and Prevention’s 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel for emergency use.
In April this year, Promega secured approval for the usage of its GoTaq Probe 1-Step RT-qPCR System in Centers for Disease Control and Prevention’s (CDC) Covid-19 EUA diagnostic panel.