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:
Collect and store patient samples
Ship samples to testing laboratory
Extract RNA from samples
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.
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.
This blog is written by guest blogger, Heather Tomlinson, 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.
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 is the Director for the Global Clinical Diagnostics Strategic Business Unit at Promega Corporation with over 15 years of experience in clinical diagnostic test development. She is responsible for leading the team that drives strategy in the clinical market for Promega. Her background is in infectious disease diagnostic testing, with a focus on HIV drug resistance and evolution. Her recent work has been in oncology companion diagnostic test development. Heather has is an accomplished international presenter, delivering conference presentations in the United States, Europe, Asia, and Africa.
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.
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 throughour 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.
Today’s blog is written by Ashley G. Anderson, MD, Chief Medical Officer at Promega.
The need for reliable virus detection methods is central to the global response to COVID-19. These test results not only inform health decisions for individual patients, but they also help us build projections of how the virus will spread, which can in turn influence policy decisions.
Following the emergence of COVID-19, PCR-based tests were developed and deployed to detect the virus in patients in hospitals. PCR, or Polymerase Chain Reaction, is a common technique used in labs to amplify large quantities of DNA. The detection tests use swabs placed deep into the back of the nose to detect genetic material carried by SARS-CoV-2, the virus causing COVID-19.
Those tests have been crucial to monitoring infection rates and informing patient treatment, but at this point they have fallen short of providing an overall picture of the pandemic. We know that thousands more cases have likely gone untested due to mild or unnoticed symptoms or lack of access to tests. Since PCR-based methods can only tell us if the virus is active in the patient at the time of sample and offer no information about whether a patient has been infected in the past, we currently have no way to determine how many of these unconfirmed cases exist or which patients have recovered. Serological assays are the one of the most promising tools to address that question.
This blog is written by Sara Mann, General Manger, Promega North America Branch
Promega is part of a new public-private partnership among Wisconsin industry leaders to increase the state’s laboratory testing capacity for COVID-19. I am pleased to represent Promega in this effort. The valuable insight we at Promega are gaining every day through our participation in this innovative partnership not only benefits Wisconsin labs, it also provides unique understandings about how we can best meet the testing needs of our customers around the world.
The new partnership includes laboratory support from Exact Sciences, Marshfield Clinic Health System, UW Health, as well as Promega. These organizations, along with the Wisconsin Clinical Lab Network, are sharing knowledge, resources, and technology to bolster Wisconsin’s testing capacity. Our goal is to help labs find the quickest approach to the most tests with their validated methods.