This talk will cover the rapidly evolving area of SARS-CoV-2 diagnostics from 2020-2022, highlighting recent trends, as well as our experience with central lab and distributed testing.

This presentation will discuss the evolution of molecular diagnostics for SARS-CoV-2 testing at a cancer hospital from the beginning of the pandemic to current state including development and implementation of laboratory-developed tests to SARS-CoV-2 variant testing.

The ongoing coronavirus (COVID-19) outbreak has taken thousands of lives, and the number of infections is growing daily. In this webinar we will discuss the utility of single cell technologies to advance infectious disease research, highlighting how the scientific community can respond to such events.

Imec has developed a SARS-CoV-2 test that combines an ‘easy’ breath sample and a sensitive PCR analysis on chip (<15min). The silicon chip at the core combines efficient aerosol collection and low impedance to air flow so a sample can be collected with a 1-minute breath. This platform demonstrated in SARS-CoV-2 will unlock the potential of breath specimens for diagnostics, novel biomarkers, and research in pandemic management and in other indications.

As the COVID-19 pandemic has progressed and common respiratory infections have re-emerged, the need to simultaneously test for multiple pathogens is more apparent than ever. This has been compounded by the fact that there is no way to definitively diagnose COVID-19 versus other common respiratory illnesses based on clinical symptomology. The aim of this presentation will be to review SARS-CoV-2 and COVID-19 clinical symptomology in relation to other common respiratory viruses, to better understand the testing needs for SARS-CoV-2 and traditional respiratory pathogens, and to review work done on multiplex respiratory pathogen identification.

In this session we’ll review several use case scenarios that cover inpatient, outpatient, and employee testing locations. We will outline each of the testing options that were available, what factors affected the decision process, and how to narrow down the best test for each. Selecting molecular point-of-care tests in the last 20 months was sometimes strongly dependent on the global supply chain and manufacturing limitations and learning how to overcome those challenges. Lastly, we’ll conclude with a brief overview of the best practices that were identified through the course of this pandemic and how they may influence future decisions for selecting molecular POCT.

From the first SARS-CoV-2 assays to genotyping, the demand for testing has put considerable burden on clinical laboratories. Laboratories are faced with juggling pre-op screening, symptomatic and asymptomatic testing, viral load estimation, and more recently, genotyping to meet the demands of the “New Normal” in COVID-19 testing. This juggling act hinges on diagnostic stewardship, regulatory compliance, logistics, and various technical constraints. This presentation will focus on how one academic institution is navigating through this “New Normal” in COVID-19 testing.

The large number of infectious agents in blood and the continually emerging agents are a constant challenge for diagnostic and blood donor screening devices. To increase sensitivity, multiplicity and speed sample to answer, new technologies must be designed and tested. We have tested the OpenArray spatially multiplex platform, the resequencing microarray, and are now applying the Oxford Nanopore MinION next-generation sequencer to high specificity identification of pathogens in blood.

The avalanche of easy-to-create genomics data has impacted almost all areas of medicine and science, from cancer patients and microbial diagnostics to molecular monitoring for astronauts in space. In this seminar, new discoveries from RNA- and DNA-sequencing across dozens of cities on Earth will be detailed, including the analysis of wastewater as a means to track SARS-CoV-2 levels, and also explore the investigation of new species found on the International Space Station. Recent technologies and algorithms from our laboratory and others demonstrate that an integrative, cross-kingdom view of patients (precision metagenomics) holds unprecedented biomedical potential to discern risk, improve diagnostic accuracy, and to map both genetic and epigenetic states around the world and in real-time. Finally, these methods and molecular tools work together to guide comprehensive, longitudinal, multi-omic views of human astronaut physiology in the NASA Twins Study, which lay the foundation for future long-duration spaceflight, including sequencing, quantifying, and engineering genomes to survive on other planets over the next 500 years.

Laboratory diagnosis has never been more visible to patients, the public, and healthcare than it currently is. This talk focuses on contemporary lessons, and challenges in the continued diagnostic scene, including the application of diagnostics on new COVID-19 therapies, the impact of rapid PCR as a supplement to public health sequencing efforts, and the need for multiplex assays to address upcoming challenges posed by "twindemic" viruses (COVID-19 & RSV). 

From molecular diagnostics based on PCR and next generation sequencing (NGS), to those incorporating CRISPR, strategies used in the design of in vitro diagnostic (IVD) assays increasingly take advantage of disruptive technologies at the forefront of innovation. This presentation will review unique technologies used in diagnostics testing, provide insight into case studies on the development of assays with diagnostic customers, and end with an overview of custom manufacturing capabilities at MilliporeSigma.

SARS-Cov-2 first appeared in December 2019 in Wuhan China and many Variants of Concern (VOC), like the highly transmissible Delta variant, pose a serious threat to global public health. A large number of efforts have been spent on the monitoring of VOC and to assess the clinical performance of diagnostic assays. In May 2020, NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed development of COVID-19 testing and to increase testing capability. In this session, I will review RADx activities related to development of variant agnostic assays and new approaches for the rapid surveillance of COVID-19 variants.

Viral variants have emerged with resistance to the current vaccines targeting coronavirus disease 2019 (Covid-19). The increased transmissibility or virulence is hindering public health measures. Therefore, it is imperative that rapid, low-cost diagnostics are available with the ability to diagnose and identify variants. In this presentation, we describe our low-cost DNA microarray that has the ability to diagnose, identify variants present in the population, and rapidly adapt to novel mutations.

SARS-CoV-2 viral genome sequencing has been a valuable tool for the clinical diagnostics, infection prevention, public health, and epidemiologic communities since the start of the pandemic. The value of SARS-CoV-2 sequencing data continues through waves of increasing and decreasing case prevalence. Viral sequencing in northern New England was helped through collaborative efforts between departments and institutions. Similar collaborative models could be a useful approach for to bring together clinical specimens, patient data and a variety of skills to provide important biomedical information.

Biomeme, an emerging leader in portable molecular diagnostics and infectious disease testing solutions, has developed a first-of-its-kind quantitative real-time PCR platform to measure host response tests for pre-symptomatic detection of viral infections and accurate discrimination of viral from bacterial infections at the point-of-need. This test solution will inform appropriate use of antibiotics and more generally, empower clinicians to deliver precision medicine solutions for other infectious and inflammatory diseases.

The pandemic has provided a watershed moment for new diagnostics for respiratory viral infections. The vast majority of new approaches focus on pathogen detection whether at the hospital, the clinic, or in the home but have limitations. Respiratory or whole blood host response signatures using diverse analytes (mRNA, cytokines, DNA methylation) show promise for augmenting diagnostic and prognostic accuracy.

We describe a label-free electrochemical immunosensor for interleukin- in human cerebrospinal fluid (CSF) and serum, capable of quantitation in the range 1 pg mL-1 - 1 µg mL-1. The sensor can deliver rapid results (~ 3 min) for traumatic brain injury and potentially also address an unmet need for diagnostics for other cytokine-related illnesses, such as sepsis and COVID-19 induced cytokine storms.