This post is written by guest blogger, Melanie Dart, PhD, Sr. Research Scientist at Promega.
Along with lockdowns and sheltering in place efforts, the COVID-19 pandemic brought a unique challenge to our doorstep this spring: developing a clinical serological test for COVID-19 to detect the presence of antibodies against the SARS-CoV-2 virus. The project was one of the fastest, most dynamic development efforts ever undertaken at Promega. In general, in vitro diagnostic (IVD) tests take at least one to two years to develop. Nothing about 2020, however, has been typical.
It was important to move quickly. We set an aggressive timeline, and to meet it we needed not only dedication of our internal team, but also contributions from the local community.
Moving Quickly with Creative Problem Solving
Antibody testing, also known as serology testing, is used to detect antibodies to COVID-19 in the bloodstream. Antibodies can indicate that a person had COVID-19 in the past, and this type of testing is critical to monitoring infection rates and spread in communities, as well as providing information that can lead to vaccines and therapies.
The Lumit™ platform was quickly identified as the best basis for our test because of the innovative way it detects proteins and antibodies. Antibody detection with the Lumit™ Technology uses an ELISA-like format with a substantially simplified workflow. We had already been brainstorming ways to use this detection platform for diagnostic or drug monitoring purposes. The global need for COVID-19 testing inspired us to fast forward this effort.
Before we could collect samples and begin development, the highly infectious nature of COVID-19 required the appropriate laboratory setup. We needed a biosafety level 2 (BLS2) lab, and we needed it quickly. I came to Promega eight years ago, trained in immunology and with previous experience in establishing clinical research programs and handling BLS2-level samples. I was asked to work with our team, and in two weeks we had converted a space the size of a broom closet into our new BLS2 lab.
With safety precautions in place, what we still did not have was access to blood samples from donors who had contracted and recovered from COVID-19—a component critical for researchers developing a blood test. Labs that would usually provide these types of samples were inundated with requests and with our ambitious development schedule, we needed to find an “outside the box” approach.
Our answer was to look to our community. We appealed to those in Madison, WI, and the surrounding area for volunteers who had tested positive for COVID-19 and recovered.
A Community Comes Forward
Within the first two weeks, around 40 people had come forward, and eventually, more than 100 people participated in our SARS-CoV-2 (COVID-19) Antibody Study. With my clinical background, I was able to work with the medical director and nurse practitioner at our wellness center to help collect samples and train additional staff to help with processing. I was also part of the team that worked directly with volunteers.
The actual donation process only took 5 to 10 minutes, but many volunteers stayed longer to share their experiences with COVID-19. Many of these stories were heartbreaking, including hospitalizations and lost family members. You could say we were collecting samples and stories.
It was amazing how our local community came forward to donate their blood to help us better understand the virus. Being with the people who experienced COVID-19 first-hand, hearing their stories, that’s what fuels my fire as a scientist. They gave us the drive to develop our antibody assay.
Without our community donors, we would not have made the progress that we did. The benefit of working locally was that we had real-world samples that were a representation of a typical community. This sample set gave us more realistic data as we were developing the test.
Introducing the Lumit™ Dx SARS-CoV-2 Immunoassay
With access to samples, our team was able to move steadily toward our goal of creating a serology assay. We diversified our sample cohorts with samples from commercial vendors so that we could improve our immunoassay.
The development team worked around the clock, napping a couple of hours a night, seven days a week. At the same time, we were also working amid COVID-19 restrictions, meaning that while half of the team members were in the lab performing the necessary experiments, the other half were running data at home. Work involved sample collection, processing, and testing the assay concurrently with assay development, under an everchanging FDA landscape.
It took a bit longer than our ambitious ten-week timeline, but we launched our Lumit Dx SARS CoV-2 Immunoassay. The test utilizes the Promega NanoBiT® bioluminescence complementation technology to generate a luminescent signal detected on a luminescent-capable microplate reader when SARS-CoV-2 antibodies are present in a serum or plasma sample. The quick and simple workflow is easily adaptable to most liquid handlers and features an add-incubate-read format with no wash steps, reliable results in less than an hour at room temperature, scalable for high throughput needs, and antibody detection against the RBD antigen within the SARS-CoV-2 spike (S) protein.
We have submitted an application to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA).
We could not have accomplished this without the help of the community donors who stepped forward in the early days of the pandemic. Since our study was for research and assay development, we could not provide them any results, and they did this purely out of a drive to help science. Some participants are even continuing to come back to be tested to provide us data on what happens to the antibody response over time with people who have had COVID-19.
These are extraordinary people who stepped up for science. I’m incredibly fortunate to have been in the right place at the right time to witness this firsthand. My heartfelt “thank you” goes out to every one of them.