A Specific & Sensitive Matter: The Trouble with COVID-19 Antibody Tests

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

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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Adapting Our Projects, Our Experiments, and Ourselves to Support COVID-19 Response

The COVID-19 pandemic has affected virtually everyone’s lives and business, and Promega is no exception. If you’re a frequent reader of Promega Connections, you have probably noticed that many of our recent blog posts have mentioned the novel coronavirus.

Madison Scientific Applications Team working on projects before physical distancing.

As Applications Scientists at Promega, we have adapted our work to enable support of our Promega colleagues and their customers as they respond to the pandemic. Like other groups in the company, we have ramped up our efforts. Our team typically has a broad focus on a variety of projects from across market segments of the company. During the second week of March, we switched to completely focus on virus-related experiments. Everyone on our team was in the lab collaborating on a large project to determine which kits could be used to purify viral nucleic acid from universal transport medium for virus (UTM®) and sputum, knowing that customers would be using any kit that they had on hand to do testing quickly. We completed testing in two days and data analysis and write-up within another couple of days.

In the last six weeks, we have worked on over 30 projects and completed almost 20 of them. In some cases, we identified, resourced, and began projects in the same day. In other cases, we completed projects within a day or two of receiving the request. You can find some of our data, presented as “Viral RNA Extraction Application Notes”, here.

Many projects originated from direct questions from global branches, Technical Services, and other internal colleagues on behalf of their customers. Some projects resulted from a need we identified, such as testing alternative storage methods for swab transport due to shortage of UTM®. Projects ranged from testing purification kits with relevant sample types, to comparing amplification reagents, and participating in work on forthcoming virus-related products.

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Fighting the COVID-19 Pandemic With Antibody Testing: The Importance of Serological Assays

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.

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Meeting Customer Needs in Response to Market Dynamics: Responding to the Coronavirus Pandemic

Today’s blog is written by Chuck York, VP of Manufacturing Operations at Promega.

Coronavirus SARS-2-CoV continues to fuel unprecedented demand for COVID-19 related products. Once a term relegated to virology research labs, “coronavirus” is now a household term and a global crisis that has upended lives, disrupted entire economies and shaken our sense of normalcy.

Clinicians, researchers, government officials and the general public are understandably concerned about the availability of reagents for coronavirus testing. At Promega, we are hearing the needs and concerns of our scientific colleagues and partners, and we are doing all that we can to help alleviate them.

At Promega, we are hearing the needs and concerns of our scientific colleagues and partners, and we are doing all that we can to help alleviate them.

As a global company with thousands of products, we have been meeting customer demand in response to market dynamics for decades. Our long-term approach has served customers well. Our efforts to provide support for the COVID-19 response began in early January, with our work with our colleagues and customers in China. We are applying what we’ve learned to propel us forward in the most efficient way now.  

We continue to increase production of all COVID-19 related reagents and instruments due to an unprecedented increase in global demand. Production lines that were running one shift 5 days a week are now operating 3 shifts seven days a week, and we continue to take measures to increase our manufacturing capacity.

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RNA Extraction for Clinical Testing—Do Not Try this with Home-brew

This blog was written with much guidance from Jennifer Romanin, Senior Director IVD Operations and Global Service and Support, and Ron Wheeler, Senior Director, Quality Assurance and Regulatory Affairs at Promega.

A Trip Down Memory Lane

Back in the day when we all walked two miles uphill in the snow to get to our laboratories, RNA and DNA extraction was a home-brew experience. You made your own buffers, prepped your own columns and spent hours lysing cells, centrifuging samples, and collecting that fluorescing, ethidium bromide-stained band of RNA in the dark room from a tube suspended over a UV box. Just like master beer brewers tweak their protocols to produce better brews, you could tweak your methodology and become a “master isolater” of RNA. You might get mostly consistent results, but there was no guarantee that your protocol would work as well in the hands of a novice.

Enter the biotechnology companies with RNA and DNA isolation kits—kits and columns manufactured under highly controlled conditions delivering higher quality and reproducibility than your home-brew method. These systems have enabled us to design ever more sensitive downstream assays–assays that rely on high-quality input DNA and RNA, like RT-qPCR assays that can detect the presence of a specific RNA molecule on a swab containing only a few hundred cells. With these assays, contaminants from a home-brew isolation could result in false positives or false negatives or simply confused results. Reagents manufactured with pre-approved standard protocols in a highly controlled environment are critical for ultra sensitive tests and assays like the ones used to detect SARS-CoV-2 (the virus that causes COVID-19).

The Science of Manufacturing Tools for Scientists

There are several criteria that must be met if you are producing systems that will be sent to different laboratories, used by different people with variable skill sets, yet yield results that can be compared from lab to lab.

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Testing for COVID-19: How it Works

Depending on your viewpoint, source of information and tolerance for risk, this can be a frightening time for persons all over the planet. The level of disruption to daily life that we’re all experiencing due to COVID-19 is unprecedented.

We are all either not working, working from home and away from our normal offices, or in some cases working many more hours to cover for sick coworkers and caring for SARS-CoV-2-infected persons.

But there is good news if you find that information is power. We hope that some information about the testing being used in the US for this novel coronavirus might be fuel for you, empowering in terms of information.

What is the Name of the Virus, and the Disease?
Since this is a global pandemic, the World Health Organization was instrumental in naming the virus and disease. From this web page: the disease is called COVID-19.

The coronavirus responsible for this disease is SARS-CoV-2.

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