COVID-19 testing

From Drug Use to Viral Outbreaks, How Monitoring Sewage Can Save Lives

Posted on by Johanna Lee

Most of us, after we flush the toilet, don’t think twice about our body waste. To us, it’s garbage. To epidemiologists, however, wastewater can provide valuable information about public health and help save lives.

History of Wastewater-Based Epidemiology

Wastewater-based epidemiology (WBE) is the analysis of wastewater to monitor public health. The term first emerged in 2001, when a study proposed the idea of analyzing wastewater in sewage-treatment facilities to determine the collective usage of illegal drugs within a community. At the time, this idea to bridge environmental and social sciences seemed radical, but there were clear advantages. Monitoring wastewater is a nonintrusive and relatively inexpensive way to obtain real-time data that accurately reflects community-wide drug usage while ensuring the anonymity of individuals.

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Buckling Down to Scale Up: Providing Support Through the Pandemic

Posted on by Riley Bell

The past year has been a challenge. Amidst the pandemic, we’re thankful for the tireless work of our dedicated employees. With their support, we have continuously stayed engaged and prepared during all stages of the COVID-19 pandemic so that we can serve our customers at the highest levels.

How We Got Here

The persistent work by our teams has made a great impact on the support we can provide for scientists and our community during the pandemic. From scaling up manufacturing to investing in new automation, every effort has helped.

Promega has a long history of manufacturing reagents, assays, and benchtop instruments for both researching and testing viruses. When the pandemic began in 2020, we responded quickly and efficiently to unprecedented demands. In the past year, we experienced an approximately 10-fold increase in demand for finished catalog and custom products for COVID-19 testing. In response to these demands, we increased production lines. One year ago, we ran one shift five days per week. Currently, we run three shifts seven days per week. This change has allowed 50 different Promega products to support SARS-CoV-2 testing globally in hospitals, clinical diagnostic laboratories, and molecular diagnostic manufacturers. Additionally, our clinical diagnostics materials make up about 2/3 of COVID-19 PCR tests on the global market today. Since January 2020, Promega has supplied enough reagents to enable testing an estimated 700 million samples for SARS-CoV-2 worldwide.

Developments and Advances

Promega products are used in viral and vaccine research. This year, our technologies have been leveraged for virtually every step of pandemic response from understanding SARS-CoV-2 to testing to research studies looking at vaccine response.

Promega product: The Lumit™ Dx SARS-CoV-2 Immunoassay

Who Got Us Here

We are extremely grateful for our employees. In the past year, we hired over 100 people and still have positions open today. While welcoming newcomers, this challenging year also reinforced the importance of our collaborative culture. Relationships at Promega have been built over multiple years. The long history of our teams allows us to stay coordinated while prioritizing product distribution to customers across the globe. It also leads to effective communication with colleagues and vendors. Those leading our manufacturing operations team, for example, have an average tenure of 15 years. Their history in collaborating through challenging situations helps them quickly focus where needed most.

Our 600 on-site employees support product manufacturing, quality, and R&D. They do it all while remaining COVID-conscious by social distancing, wearing masks, working split shifts, and restricting movement between buildings. While we continue to practice physical safety precautions, we also prioritize our employees’ mental health and wellness. Promega provides a variety of wellness resources including phone and video mental health sessions, virtual fitness and nutrition classes, and stress and anxiety tools.

What’s to Come

While we acknowledge that the COVID-19 is not over, we are proud of the support we have been able to provide to customers working both on pandemic research and critical research not related to COVID-19. Our policies of long-term planning and investing in the future has allowed us to respond quickly and creatively and learn from the experience.

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From Viral Outbreak to Vaccine Development: Our Top 10 Most Viewed Blog Posts of 2020

Posted on by Riley Bell
This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. Photo Credit: Alissa Eckert, MS; Dan Higgins, MAM CDC It is one is used in several of our top 10 most viewed blogs of 2020
Illustration from CDC; Photo Credit: Alissa Eckert, MS; Dan Higgins, MAM

When you look at our top 10 most viewed blog posts of 2020, there’s no surprise that all relate to COVID-19. We have come a long way since the beginning of the year, thanks to tireless scientists and researchers around the globe. They have led the way in COVID-19 research, treatment, and testing. Let’s take a closer look at this top 10 list:

10. Tips to Maintain Physical Distance in the Lab 

The spread of COVID-19 forced us to adapt and adjust to new ways in life, in work, and for this blog post, in the lab. In response to the pandemic, some labs shut down completely. Others have stayed open, especially those involving coronavirus research. This post provides 10 helpful distancing tips for researchers to stay safe and productive while working in the lab.  

9. Investigation of Remdesivir as a Possible Treatment for SARS-2-CoV (2019 nCoV) 

Scientists have worked hard to determine possible treatment for COVID-19. This blog post focuses on Remdesivir (RDV or GS-5734), an encouraging treatment used for the first case in the United States. It provides an in-depth look at numerous studies and clinical trials on Remdesivir as treatment for COVID-19. One key finding is that RDV needed to be administered either before or shortly after infection to limit lung damage. 

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Automation Helps A Graduate Student Monitor COVID-19 With Wastewater

Posted on by Johanna Lee
Kasia Slipko (middle) and her lab at Vienna University of Technology. She and colleagues are exploring using wastewater to monitor viral disease outbreaks.
Kasia Slipko (middle) and her lab at Vienna University of Technology. She and colleagues are exploring using wastewater to monitor viral disease outbreaks.

When Kasia Slipko started graduate school at Vienna University of Technology, Institute for Water Quality and Resource Management, she was interested in studying antibiotic resistant microbes in wastewater. For three years, she evaluated different wastewater treatment methods to find out how to remove antibiotic resistant bacteria. But in the spring of 2020, her research took an unexpected turn. That was when the COVID-19 global pandemic hit, caused by the rapid spread of the SARS-CoV-2 virus. Kasia soon found herself at the forefront of another exciting field: using wastewater to monitor viral disease outbreaks.

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How A New SARS-CoV-2 Wastewater Testing Kit is Helping Campuses Reopen

Posted on by Johanna Lee

The fall of 2020 was like no other, especially for universities. The COVID-19 pandemic hit most of the world in the spring, forcing schools and businesses to close. For months, people worked from home and schools switched to online classes. When fall came, universities had a difficult decision to make. Do they have students and staff come back to campus for in-person classes? With students living together in close proximity in dormitories, an outbreak could quickly get out of hand. How can the university monitor and control the spread of the virus to ensure everyone’s safety?

This was when Robert Brooks started getting calls. He’s the Technical Director and Operations Manager at Microbac Laboratories in Oak Ridge, Tennessee. Microbac is a network of privately owned laboratories that provide testing services for food products, environmental samples and the life science industry. Robert has been in the lab industry for 25 years and has established a reputation for taking on difficult problems. “We really try to go that extra mile to help clients solve their issues. That has made a name for us out there. When people have odd-ball issues, they give us a call cause we’re going to take a look at it from a couple different viewpoints and take a step-by-step approach,” he says.

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Rapid COVID-19 Testing, International Collaboration, and a Family Favor

Posted on by Jordan Villanueva

When the COVID-19 pandemic descended on New York in March 2020, Christopher Mason, PhD, knew he was in a unique position to contribute. The Mason Lab specializes in sequencing and computational methods in functional genomics – valuable expertise for addressing an emerging infectious disease. Within days, Chris and his team were helping to analyze patient data, as well as developing new tests and detection methods for the SARS-CoV-2 virus.

3d model of coronavirus covid-19

The Mason Lab developed protocols for a simple COVID-19 detection test that requires less time and equipment than common PCR methods. Their subsequent preprint detailing these methods quickly gained widespread attention, and Chris found himself fielding an endless stream of questions and requests.

During the frenzy, Chris received a call from his older brother. Cory Mason is the mayor of Racine, Wisconsin, the brothers’ hometown.

“He said he saw me tweeting about our new test,” Chris says. “Then he asked me, ‘What if we set it up here in Wisconsin?’’

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XpressAmp™ Direct Amplification: Simplified and Accelerated Time to qPCR Results

Posted on by Natalie Larsen

As the SARS‐CoV‐2 pandemic continues to rage across the United States and around the globe, the demand for COVID‐19 testing is increasing. The vast majority of the COVID-19 assays use RT‐qPCR to detect the viral RNA in patient samples such as nasopharyngeal swabs, which are collected and stored in viral or universal transport media (VTM/UTM). The general workflow for these COVID‐19 assays can be broken down as follows:

  1. Collect and store patient samples
  2. Ship samples to testing laboratory
  3. Extract RNA from samples
  4. Amplify and analyze samples

While many companies who manufacture the products that are used in these steps have been able to adapt and significantly increase their production capacities, there are still gaps between the supply of these products and the global test demand. Both the sample collection and storage step and the RNA extraction/purification step have a tendency to bottleneck and experience supply constraints. One way to address these bottlenecks and expand production capacity for these in‐demand products is to evaluate the viability of skipping a step in the workflow, without hindering the ability to detect viral RNA from samples.

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Emergency Use Authorization: The What, the Why and the How

Posted on by Promega

This blog is written by guest blogger, Heather Tomlinson, former Director of Clinical Diagnostics at Promega.

Finding safe and effective treatments for human diseases takes time.  Medication and diagnostic tests can take decades to discover, develop and prove safe and effective.  In the United States, the FDA stands as the gold-standard gatekeeper to ensure that treatments and tests are reliable and safe. The time we wait in review and clearance means less risk of ineffective or unsafe treatments.

And yet, in a pandemic, we are behind before we even start the race to develop diagnostic tests, so critical for understanding how an infectious disease is spreading. That is when processes like the FDA’s fast track of Emergency Use Authorization (EUA) are critical. Such authorization allows scientists and clinicians to be nimble and provide the best possible test protocol as quickly as possible, with the understanding that these protocols will continue to be evaluated and improved as new information becomes available. The EUA focuses resources and accelerates reviews that keep science at the fore and gets us our best chance at staying safe and healing.

The Maxwell 48 RSC Instrument and the Maxwell RSC Total Viral Nucleic Acid Isolation Kit are now listed as options within the CDC EUA protocol.

For scientists working around the clock, the FDA’s EUA process is ready to review and respond. Getting an EUA  gives clinical labs a very specific and tested resource to guide them to the tools and tests to use in a crisis.

Typically the Centers for Disease Control (CDC) will develop the first test or protocol that receives FDA EUA in response to a crisis like a pandemic.  For COVID-19 the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel received FDA EUA clearance in early February. This is the test protocol used by the public health labs that work with the CDC and test manufacturers around the world.

Throughout a crisis such as the current pandemic, scientists continually work to improve the testing protocols and add options to the EUA protocols. This enables more flexibility in the test protocols. Promega is fortunate to play a part of the CDC EUA equation for diagnostic testing. Our GoTaq® Probe 1-Step PRT-qPCR System is one of a few approved options for master mixes in the  CDC qPCR diagnostic test,  and now our medium-throughput Maxwell 48 Instrument and Maxwell Viral Total Nucleic Acid Purification Kit  have been added to the CDC protocol as an option for the RNA isolation step as well. These additions to the CDC EUA means that laboratories have more resources at their disposal for the diagnostic testing which is so critical to effective pandemic response.

The Emergency Use Authorization provides the FDA guidance to strengthen our nation’s public health during emergencies, such as the current COVID-19 pandemic. The EUA allows continual improvement of an authorized protocol through the collaborative efforts scientists in all academia, government and industry to identify and qualify the most reliable technologies and systems, giving labs more flexibility as new products are added as options.

Dr. Tomlinson was the Director for the Global Clinical Diagnostics Strategic Business Unit at Promega Corporation bringing over 15 years of experience in clinical diagnostic test development. She was responsible for leading the team that drives strategy in the clinical market for Promega. Her background was in infectious disease diagnostic testing, with a focus on HIV drug resistance and evolution. Her last work focused on oncology companion diagnostic test development.  Heather was an accomplished international presenter, delivering conference presentations in the United States, Europe, Asia, and Africa. Heather passed away in 2023.

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A Specific and Sensitive Matter: The Trouble With COVID-19 Antibody Tests

Posted on by Natalie Larsen

From the beginning of this pandemic, scientists around the world have been working around the clock in pursuit of answers that can effectively combat the SARS-CoV-2 virus. One of hardest things for people to grapple with, is all the unknowns: When will this end? When can I safely visit my friends and family again? What if I have it or had it and I don’t even know it?  

The increased availability of serological testing has helped ease people’s minds about their personal COVID-19 status. From a distance, serological testing may seem like a huge milestone in the marathon that is this pandemic. Unfortunately, many of these tests provide murky and inconsistent results.

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Public-Private Initiative to Increase COVID-19 Testing Capacity by Using Promega Maxwell Instrument in India

Posted on by Promega

This blog is written by guest blogger, Dr Rajnish Bharti, General Manager of Promega Biotech India Pvt Ltd.

As COVID-19 cases accelerate, the country of India has decided to scale up testing capacity to 100,000 tests per day in the coming days.

In a major step to counter the coronavirus crisis, Promega India is supporting government agencies through our automated instruments. The Maxwell® RSC instrument is a compact, automated RNA extraction platform that processes up to 48 samples simultaneously in less than 35 minutes. The automated Promega solution allows laboratories to process up to 400 samples in a typical 8-hour shift.

Scientists in India train on the Maxwell RSC 48
Forensic Science Laboratory-Jaipur and SMS Hospital Jaipur join hands together to use Promega Maxwell® RSC 48 to Increase COVID-19 Testing capacity.
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