Lateral Flow Immunoassays (LFI) are simple devices used in field forward settings to detect the presence of biological agents in a sample matrix without the need for heavy and costly equipment. There is a need for multiplex LFI devices especially in scenarios where sample volume is particularly limiting and cutting time and assay costs are critical.  BlindSpot is a customizable multiplex format that utilizes the Braille alphabet to assign letters in a combination of 6 spots to a specific biological threat (i.e. P for Bacillus anthracis). Using spots instead of traditional lines, BlindSpot allows for detecting up to 6 different biological targets on a single device, without losing sensitivity or adding cost.

For users who need simplistic, high confidence, actionable information from genomic data, Battelle’s UltraSEQ software provides a flexible system architecture, high-quality data, and algorithms for biothreat organism and function identification, unlike rigid existing approaches that are slow, non-standardized, and imprecise. UltraSEQ’s base functionality takes input genomic data and efficiently outputs prediction results for taxonomy, biothreat function, and a user-defined rules engine. UltraSEQ’s demonstrated application for biothreat sample analysis, diagnostics, and biosurveillance will be presented. 

BARDA’s Early Notification to Act, Control and Treat (ENACT) program seeks tools to identify and characterize signatures (biological, biometric, behavioral, and physiological) that can inform on health security threats or exposures prior to symptom onset in order to facilitate treatment and prevent subsequent cascading effects. Our portfolio of infection detection tools comprises wearables, novel sensors, and disease prediction platforms, and covers both influenza and COVID-19.

The rapidly evolving healthcare crisis resulting from the SARS-CoV-2 pandemic limited hospital access to personal protective equipment (PPE). This created a unique challenge which led hospitals to take unprecedented PPE reuse decisions to protect frontline providers and patients. This talk will focus on the implementation and validation of an ultraviolet germicidal irradiation (UVGI, 254nm) system used to decontaminate N95 masks for a major hospital system. Details regarding the mask holding rack design (9’ x 6’), placement of UVGI tower emitters, UV field intensity mapping (colorimetric and UVC radiometers), and MRSA contaminated mask kill testing will all be discussed.

High affinity and specificity antibodies recognizing two different epitopes of the target antigen, enable sensitive, accurate, rapid, and field-deployable analysis of complex samples as well as effective therapeutic treatments. This presentation is an overview of the Los Alamos National Laboratory’s in vitro evolution-based antibody selection pipeline, and its advantages over other selection methods as it pertains to specificity and ability to select large suites of orthogonal antibodies. Notably, since we work with human antibodies libraries, the antibodies that we develop can be used for both therapeutic and diagnostic applications. We will present recent examples of these “double duty” antibodies.

This product is a purpose-built platform that provides all the necessary operational equipment in a human-centered laboratory-workbench design such that rapid, reproducible deployment of advanced genomic technologies to field-forward locations is no longer strategically unfeasible. This mobile laboratory, Mercury Lab, is a first-of-its-kind product that was built to lower the barrier-to-entry of modern molecular hardware where it is needed most.

Aerosolized biological samples are difficult to collect and identify without the aid of large air samplers. Furthermore, since the discovery of infectious aerosolized SARS-CoV-2, there has been a critical need to automatically collect, process, and analyze air samples for biosurveillance purposes. To this end, we have developed a high-performance LAMP assay to detect SARS-CoV-2 that is amenable to automation. In addition, we have tested a miniature electrostatic precipitator (ESP) that will be used to automatically collect and elute air samples. Separately, we have also applied the SARS-CoV-2 LAMP assay for rapid screening of soldier biosurveillance samples for nanopore sequencing analysis.

The ability to detect multiple targets from many pathogens in a single sample is critical to biosurveillance activities. LexaGene’s MiQLab System is an automated sample-to-answer system with broad multiplexing capabilities. Panels containing assays in screwcap tubes allows rapid scale up and configuration of the MiQLab system to screen for novel threats causing  pandemics or biothreat emergencies. Examples of MiQLab’s applications for biothreat surveillance and diagnostics will be discussed in this talk.

We will highlight three new products that will be launching later this summer applying to environmental monitoring applications for air and liquid samples.

COVID-19 shows that there are still some capabilities needed in global biosurveillance. Existing technologies such as PCR and immunoassays remain at the forefront of use, but can be augmented with a range of methods. We will explore traditional and emerging technologies to address biosurveillance gaps.

The state-of-the-art in nucleic acid-based biodetection continues to be polymerase chain reaction (PCR), and many real-time PCR assays targeting biodefense pathogens for biosurveillance are in widespread use. These assays are predominantly singleplex; i.e. one assay tests for the presence of one target, found in a single organism, one sample at a time. Due to the intrinsic limitations of such tests, there exists a critical need for high-throughput multiplex assays to reduce the time and cost incurred when screening multiple targets, in multiple pathogens, and in multiple samples. Here, we present an amplicon sequencing based on ONT as a solution.

Infectious microbes are generally present in our environment below a threshold, but outbreaks may occasionally happen on a local, national, or global level. Endemic infections are present on an ongoing basis in a region or population, the epidemic is an outbreak that may affect several different geographic communities, and a pandemic is a term that describes an epidemic global proportion. Novel multiplex technologies play a vital role in identifying infectious pathogens and the host response. This presentation will describe the application of multiplex technologies to enhance the management of infectious disease by regional and global public health institutions.

The analysis of genomic data continues to become at the centerpiece of several detection and characterization efforts. Here we introduce different examples of microbial detection in terrestrial and aquatic environments using a set of complex biological matrices. The implications of this biodetection approach in the development of the biosurveillance and biodefense enterprise will be discussed.

In many developing countries, there is a lack of reliable diagnostic tests that have been adequately characterized for sensitivity and specificity in austere environments. In collaboration with clinical researchers in Sierra Leone, West Africa, we have characterized how sample type affects sensitivity and specificity in malaria PCRs and have determined performance characteristics of multiple assay types under conditions of high heat, high humidity, and minimal user training. We will also describe challenges inherent in implementation of stringent, technically challenging gold standard tests (microbiological, molecular) under these conditions.