The Johns Hopkins University Applied Physics Laboratory (JHU/APL) is part of the Johns Hopkins Center for Point-of-Care Tests Research for Sexually Transmitted Disease (STDs), hereafter known as the Center, and serves as the technical lead for the Technology Development Core.  The mission of the Center is to help companies accelerate their development and overcome/avoid potential hurdles that may arise.  As part of our mission with the Center, JHU/APL has developed several tools to assist companies developing point-of-care tests for STDs. One resource is the Technology Watch Database (TWD), a free online database containing diagnostic devices for sexually transmitted infections as well as COVID-19 diagnostics. In 2020, we created a new tool to assist developers by providing online access to Systems Engineering support for their technology.  The Self-Assessment Systems Engineering (SASE) tool queries applicants in 24 different areas influencing technology development. Only a subset of the 450 total questions is displayed to each applicant as determined by the current technology readiness levels (TRLs) assigned to the current technology. Responses to the SASE tool along with supplemental materials are submitted to JHU APL for review by subject matter experts from various technical areas as well as experts with experience in overall development of point–of-care assays.  A combined report is sent to the SASE applicant within approximately 30 business days and a follow-up meeting with JHU/APL is scheduled to discuss the report.  Currently, the SASE tool is free through the NIBIB POCTRN.

RADx Tech is an NIH sponsored program which started in April 2020 to rapidly increase the production of COVID-19 diagnostic tests, including POCT and lab based testing.  The presentation will highlight the innovative approach to support the selection, development, and manufacturing of novel COVID-19 diagnostic tests as well as support in deployment of testing in non-traditional environments, such as businesses and school.

Project Impulse is an effort to provide information management support to ad hoc, non-traditional point of care (POC) COVID-19 testing sites using mobile devices and a secure, HIPAA compliant mobile application.  Commercial off the shelf (COTS) COVID diagnosis (Dx) test kits currently lack the ability to log, track and report results back to the military healthcare system (MHS) electronic systems of record from nontraditional POCs (e.g. parking lots, gymnasiums and/or more austere locations), without regard to proprietary or other limiting factors for their solutions. 

The Division of Detection, Diagnostic and Devices Infrastructure (DDDI) is a service organization that funds all of hte Biomedical Advanced Research and Development Authority's (BARDA’s) medium and late stage development for Diagnostics and medical devices.  The focus of DDDI is on detection of CBRN threats, Influenza, and Emerging Diseases such as Zika, we fund development of home tests and wearable devices, Point Of Care (POC) and Laboratory diagnostics assays and instruments.  DDDI also supports development of ventilators that are portable and easy to use, as well as Respiratory protective Devices (N95’s). Through our Innovations Program, BARDA is supporting research and development of home tests and wearable devices that will empower the individual and take detection from the traditional health care settings into the home. Early identification allows time-sensitive action by individuals to provide care to the infected individual and protect others from infection. Due to the public health emergency needs that BARDA addresses, Point of Care diagnostics are a very important part of the portfolio. We are developing tests that are useful in doctor’s offices, emergency rooms, temporary facilities like gymnasiums, and even tents. For certain threats, high throughput laboratory tests  are also needed due to the quantity of tests that must be run, so Laboratory tests are also funded.

This presentation will provide insights and highlights from training biosurveillance technologies, techniques, and associated activities for hundreds of soldiers, sailors, airmen, marines, civilians, and international partners domestically and abroad.

The spread of SARS-CoV-2 has amplified the need for methods to create accurate diagnostics. We developed a fast evaluation of viral emerging risks (FEVER) pipeline that generates primer and probe sets for pathogen detection. When applied to SARS-CoV-2, the FEVER assays achieved a high level of agreement against the U.S. CDC reference PCR test using clinical samples. For positive samples, we also developed a PCR assay for typing common mutations.

The Eikon platform, is designed to complete all necessary steps in a “sample to result” process. The user, whether at home, school, or work will be able to “walk away” while the system provides rapid results through the app in less than 30 minutes. In this presentation, Co-Diagnostics’ CEO Dwight Egan will introduce the Eikon platform along with Masen Christensen, Senior Design Engineer, who will describe the underlying CoPrimer technology.

The coronavirus SARS-CoV-2 has been identified as the cause of the severe respiratory disease COVID-19 pandemic. Three peptide epitopes were chosen based on the proposed binding of the virus to the wild-type human ACE2. They were synthesized with an additional propargylglycine as a bioorthogonal site for a copper-catalyzed azide-alkyne cycloaddition (CuAAC) and immobilized on a gold surface. Using surface plasmon resonance (SPR), the binding affinity of the SARS-CoV-2 receptor-binding domain (RBD) towards each ACE2 epitope was measured. Based on the epitope binding affinities, an rSAM-based biosensor will be designed and constructed for a rapid and sensitive test for SARS-CoV-2.

To obtain high purity nucleic acids for diagnostic procedure the appropriate benchtop equipment and labor intensive procedure is needed. These can be replaced by appropriately prepared magnetic nanoparticles (MNPs) which exhibit high affinity towards nucleic acids. The extraction procedure could be shortened to adsorption of the DNA/RNA at the MN surface, its magnetic separation, washing and finally nucleic acids desorption back to appropriate buffer. It reduces time and chemical requirements.

In our work, we present a sensor array for multivariate analysis based on small-molecule ratiometric fluorescent dyes. We demonstrate the sensor’s ability to differentiate bacterial species and recognize their Gram status. We also expand the sensor’s functionality to include analysis of mixed bacterial samples.

As is painfully clear with covid 19, developing the most sensitive and specific countermeasures and diagnostics for a given pandemic does not prepare us for the next emerging threat. There is a clear and imminent need for diagnostics and broad spectrum therapeutics to minimize the impact of emerging threats. Our team has been working on developing such tools, using the innate immune system as an inspiration for the development of the approach. The diagnostic strategies, and the applications to bacterial and viral pathogens will be discussed. 

Pandemics and other disasters stress the ability of our healthcare system infrastructure, resources and staff.  This presentation will describe how the Army’s Telemedicine & Advanced Technology Research Center (TATRC) worked with industry and HHS/ASPR to rapidly develop and deploy the National Emergency Tele-Critical Care Network (NETCCN) to link remote critical care expertise to frontline clinicians in the fight against COVID-19.

Use of radiation biodosimetry diagnostics for mass casualty screening of large populations has been identified as critical for emergency response during disasters involving radiation exposure.  Our current study examines application of radiation dose prediction algorithms to a more heterogeneous population using a diverse panel of biomarkers.  Our findings illustrate challenges and potential solutions for deployment of biodosimetry diagnostics for mass screening in the field.

There are currently more than 2 million SARS-CoV-2 genomes available, with thousands of different COVID-19 Pango lineages, although only a few major clusters. Mutational hot spots along the genome show correlations with RNA structures. We find three major conclusions: this virus has a limited mutation repertoire with few mutations that become fixed; the viral genome undergoes parallel evolution frequently; and finally, we see little genomic recombination.