Pivots in pathogen detection:
Adapting to a rapidly evolving testing landscape

In late December 2019, an outbreak of a mysterious pneumonia appeared in a wholesale seafood market in Wuhan, Hubei, China. Later identified as a novel beta-coronavirus and labeled SARS-CoV-2, no one could have foreseen the ongoing global COVID-19 pandemic that followed and the scale of the response needed to help bring the situation under control.

Crucial to the initial response was a means to detect and diagnose infections rapidly and accurately, which in turn required a dramatic shift in clinical diagnostic assay development, and in patient sample collection and processing. Scientists and manufacturers alike working in pathogen detection and with PCR-based technologies had to pull together to think outside of the box with the tools available to meet the demand as the spread of the virus continued at an exponential rate.

Understandably, with the sudden increase in demand and the rapid expansion of testing menus, clinical testing laboratories became quickly overwhelmed. They had to be adaptable in order to increase their capacity and throughput, and leaned on the technologies supplied by manufacturers who were flexible and willing to adapt with them.

Fast forward to present day, and this collaborative approach between leading manufacturers, scientists, and clinical professionals has continued to prosper in many areas, expanding well beyond the scope of COVID-19 and the monitoring of variants, to supporting patient screening across a wide range of conditions.

In this interactive resource, we explore these partnerships in more detail, looking at specific accounts and triumphs at various timepoints, how technologies have evolved, and what the landscape of patient testing might look like going forward as the public health crisis evolves.

From R&D to validation, the field of molecular diagnostics is fraught with challenges. SelectScience, in partnership with LGC Biosearch Technologies, is exploring the challenges facing the development of molecular diagnostics and the solutions available to help support your journey from an exciting start-up to a thriving MDx organization.

Overcoming adversity

At the start of the COVID-19 pandemic, an early diagnosis quickly became one of the most important factors in disease prevention and transmission control.

It was critical that an effective and widely available method of diagnosis could be achieved to reduce the rate of transmission, to establish a relationship between symptoms and a positive SARS-CoV-2 diagnosis, and to monitor the emergence of variants. Collaborative research groups comprised of researchers and clinical professionals began to work tirelessly to develop PCR-based molecular tests that could provide rapid, inexpensive, and high-throughput results.

Researchers from other backgrounds such as plant biology or agriculture, but with valuable expertise in pathogen detection and assay development, also found themselves working to support the human diagnostics sector. They often offered up their otherwise empty labs with existing PCR systems and re-purposed them for population-scale COVID-19 testing.

To help bring all these solutions to fruition, scientists had to partner with manufacturers that could offer a hands-on approach to working with their customers, along with the expertise and manufacturing platforms that could deliver a customized product with repeatability and consistent performance. In the interviews below, we explore a few examples of these partnerships and how providers were able to adapt to frequent changes in testing demand.

Dr. Anne Wyllie, Research Scientist, Yale School of Public Health and Principal Investigator, SalivaDirect, talks about the advantages of a COVID-19 test that uses saliva and how it is supporting testing laboratories.

Honing the response

As testing capacity increased and successful vaccination programs began to roll out across the world, partnerships between scientists, healthcare professionals, and manufacturers strengthened as they turned their focus to assay optimization and automation.

With a greater understanding of the mechanisms of infection and nature of SARS-CoV-2, scientists quickly began to challenge the accuracy and reliability of the molecular methods that were initially established in the early response. Much of that attention was given, and continues to be given, to RT-qPCR, the primary diagnostic method for SARS-CoV-2 infection, with a particular focus on target specificity and maintaining sample integrity to prevent false positives.

To help expand pathogen PCR testing infrastructure and support mass testing, manufacturers, such as LGC Biosearch Technologies, focused on developing ultra-high-throughput PCR systems, with automated purification and amplification workflows that could accommodate up to 150,000 tests per day.

In the resources below, explore a case study looking at the discrepancies in COVID-19 testing formats, and download three free application notes detailing guidance on effecting RT-qPCR, and how similar method refinements can be applied to the detection of other pathogens of concern.

Is it really negative? The importance of using accurate metrics for COVID-19 diagnosis

As the WHO set guidelines for measuring COVID-19 viral loads during clinical diagnosis, one research group challenged the accuracy of this metric (and provided a better alternative).

In this article, we speak with Daniel Evans, University of Surrey, and UK National Measurement Laboratory, about the dangers of using incorrect measurement units to quantify viral loads in COVID-19 patients.

Shared progress in other areas

Although the COVID-19 pandemic has dominated the testing landscape in recent years, the same level of partnerships between scientists and manufacturers to combat the virus have also been seen in patient screening for a wide range of conditions.

With the success of vaccination programs and the lifting of restrictions and social precautions in many areas of the world, the focus of clinical testing laboratories now shifts back to cater for all infectious disease testing. Taking learnings from the fight against COVID-19, scientists and manufacturers have continued to work together to overcome hurdles with the detection of other respiratory pathogens such as respiratory syncytial virus (RSV), parainfluenza, and common cold-type coronaviruses, as a resurgence in cases has been observed.

Antimicrobial resistance, considered by many as a ‘hidden pandemic’, has also begun to re-enter the spotlight as a major concern to health services across the globe. Leveraging the same technologies that supported the early diagnosis of SARS-CoV-2, scientists and manufacturers are now working to improve rapid identification of resistant infections through molecular techniques to inform therapeutic approaches.

Combating a ‘hidden pandemic’ with resistance-guided therapy

Through an editorial interview and a live round table discussion, we explore how the partnership between molecular diagnostics innovator SpeeDx, and Prof. Catriona Bradshaw, Head of Research Translation and Mentorship and Genital Microbiota and Mycoplasma Group Lead at Melbourne Sexual Health Centre, has led the development of a ‘resistance-guided therapy’ approach to treating and managing sexually transmitted infections (STIs).

The sbeadex Pathogen Nucleic Acid Purification Kit for isolation of nucleic acids from a broad range of sample matrices

Key to the successful detection of human pathogens is the reliable purification of nucleic acids.

In this application note, explore how the sbeadex™ Pathogen Nucleic Acid Purification Kit from LGC Biosearch Technologies can be used to purify DNA and RNA from a variety of respiratory disease samples for downstream qPCR, RT-qPCR, and next generation sequencing (NGS) applications.

A partner for every pivot

Throughout the COVID-19 pandemic, LGC Biosearch Technologies demonstrated a unique ability to serve the diagnostic community as a reliable mission-critical component supplier.

Recognizing the need for a close partnership with its customers, LGC Biosearch Technologies prides itself in being able to offer expertise to leverage its flexible manufacturing platforms. By being able to deliver according to exact specifications and throughput, LGC Biosearch Technologies can yield a product that produces repeatable and consistent performance.

The race for five-minute point-of-care PCR testing

Learn how UK-based diagnostics company, LEX Diagnostics, has partnered with LGC Biosearch Technologies to revolutionize PCR usability and speed, bringing next-gen point-of-care diagnostics to urgent care centers, general practice, and pharmacies.

Tools and technologies to support your emerging needs

  • QuickExtract™
  • sbeadex™
  • oKtopure™
  • Probes and primers, off-the-shelf and custom oligos
  • Variant ValuPanel™ assays
  • EpiScript™ RNase H- RT
  • RapiDxFire™ Lyo-Flex 1-Step RT-qPCR 5x Master Mix
  • AccuPlex™ Reference Material
  • AccuPlex™ Verification Panel
  • LavaLAMP™ RNA and DNA Master Mixes
  • IntelliQube™
  • Nexar™
  • Hydrocycler2
  • Araya™

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