September 11, 2020 | Harvard researchers have optimized new SARS-CoV-2 diagnostic, antibody test-on-a-chip uses gold nanospikes for virus detection, 4C Mortality Score predicts disease outcome, and LSU radiologists argue for chest x-rays in COVID-19 diagnostics. Plus, scaled up testing, AI-powered reopening, more testing receives EUAs.
Research Updates
Researchers from Harvard Medical School have optimized a sample preparation and detection pipeline for a SARS-CoV-2 diagnostic test that is rapid and does not require specialized equipment. This pipeline consists of viral inactivation, rendering samples safer to work with, followed by a sensitive 30-min isothermal detection reaction with a color-based red to yellow readout. Sensitivity can be further improved using a simple and inexpensive purification protocol. This pipeline, which they published in PNAS, can help address the shortage of testing capacity and can be run in a variety of settings, they say. DOI: 10.1073/pnas.2011221117
Scientists at the Okinawa Institute of Science and Technology Graduate University (OIST) have developed a rapid, reliable and low-cost antibody test-on-a-chip described in a proof-of-concept study published in Biosensors and Bioelectronics. The chip uses an opto-microfluidic sensing platform based on Au nanospikes fabricated by electrodeposition for the detection of anti-SARS-CoV-2 spike protein antibodies. This is performed in diluted human plasma without any labeling agents. The team plans to expand the current platform for multiplexing, which is crucial to make diagnosis more accurate by detecting multiple biomarkers, such as antibodies against other COVID-19 structural proteins (membrane, the envelope, and the nucleocapsid proteins). DOI: 10.1016/j.bios.2020.112578
The 4C (Coronavirus Clinical Characterisation Consortium) Mortality Score, published in The BMJ, uses readily available data to accurately categorize COVID-19 patients as being at low, intermediate, high, or very high risk of death, and should be further tested to determine its applicability in other populations, say a team of researchers from the UK. The 4C score outperforms existing scores and can be used to support treatment decisions. To develop the model, the researchers collected routine data from 35,463 adults (median age 74 years) with covid-19 who were admitted to 260 hospitals across England, Scotland and Wales between 6 February and 20 May 2020. These data were then entered into the model to give each patient a score ranging from 0-21 points. Patients with a score of 15 or more had a 62% mortality compared with 1% mortality for those with a score of 3 or less. To validate the model, the researchers tested it on a further 22,361 patients admitted to the same hospitals between 21 May and 29 June 2020. They found similar score performance, even after taking account of other potentially important factors. DOI: 10.1136/bmj.m3339
A team of LSU Health New Orleans radiologists viewed 376 in-hospital CXR exams for 366 individual patients along with concurrent RT-PCR tests to determine the usefulness of chest x-rays in COVID-19. They found the x-rays could aid in a rapid diagnosis of the disease, especially in areas with limited testing capacity or delayed test results. The presence of patchy and/or confluent, bandlike ground glass opacity or consolidation in a peripheral and mid-to-lower lung zone distribution on a chest radiograph obtained in the setting of pandemic COVID-19 is highly suggestive of SARS-CoV-2 infection and should be used in conjunction with clinical judgement to make a diagnosis, they write in Radiology: Cardiothoracic Imaging. DOI: 10.1148/ryct.2020200280
Industry Updates
SafeSite, the medical diagnostic, mobile laboratory company, has scaled its West Coast-based testing model nationally to help schools, universities, and businesses safely and responsibly reopen. Working with new logistics partner Live Media Group, SafeSite will expand their deployment of mobile laboratories that perform rapid response COVID-19 testing, along with a data-driven personal tracking and contact tracing platform. The company’s propriety technology platform, SafeSite-PASS, is used by each organization and individual, providing QR Code-based touchless functionality with historical data of all test results stored within user profiles. SafeSite-PASS is a valuable resource for organizations seeking a HIPAA-compliant mobile technology for health monitoring that securely delivers a COVID-19-free business, school or venue location. Press release.
Tanjo AI will be powering North Carolina’s COVID-19 reopening through its artificial intelligence technology platform. As part of the 2020 COVID-19 Recovery Act, the North Carolina Policy Collaboratory in late July awarded the Digital Health Institute for Transformation (DHIT) a grant to research, validate, and build a simulation platform and Data-driven, expert backed decision engine for North Carolina business and community leaders as they navigate reopening. DHIT and Tanjo entered into a formal strategic partnership in November 2019. The platform will leverage Tanjo’s machine learning and advanced analytics to ingest huge amounts of national and regional data, including health and epidemiological data, labor and economic data, occupational data, consumer behavior and attitudinal data, and environmental data. A dashboard is being designed to give business owners and community stakeholders real-time intelligence and predictive modelling on population health risk, consumer sentiment and community resiliency. Users will be able to view the risk to their business/county, as well as simulate the impact of implementing evidence-based recommendations, enabling them to make informed decisions. Press release.
ADMA Biologics has launched COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma developed in collaboration with Leinco Technologies. ImmunoRank is intended to help identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes. ImmunoRank is designed to test up to 90 samples per test kit with 99.8% specificity. The assay procedure takes approximately 80 minutes. An Emergency Use Authorization (EUA) submission is currently being prepared for review and potential approval by the FDA. Press release.
Avacta Group, the developer of Affimer biotherapeutics and reagents, has entered into an agreement with Abingdon Health for the manufacture of Avacta’s saliva-based rapid SARS-CoV-2 antigen test as part of its ongoing expansion of manufacturing capacity. Avacta, in partnership with Cytiva, is developing a rapid test strip for use with patient saliva that aims to provide a result in a few minutes, indicating whether the patient is currently infected with the SARS-CoV-2 coronavirus. Press release.
Avacta has also launched an ELISA laboratory test for the SARS-CoV-2 spike protein. The Affimer-based ELISA test is capable of detecting the coronavirus spike protein in laboratory samples down to very low concentrations. An evaluation of the ELISA carried out with The Liverpool School of Tropical Medicine using SARS-CoV-2 virus samples shows that it can detect as little as a few thousand virus infectious units per millilitre of sample. Press release.
DetectaChem’s MobileDetect Bio (MD-Bio) BCC19 COVID-19 test kit has received FDA EUA. The BCC19 test kit uses portable laboratory-grade diagnostic technology that can run up to 96 tests per device in 30 minutes. The test detects nucleic acids from the 2019-nCoV virus to determine positive or negative results and then utilizes the free MobileDetect App for Apple and Android platforms to generate result reports with time, date, images, patient info, GPS mapping and more. Generated test reports can then be immediately sent via email or text to healthcare providers, laboratories or any other desired recipient. The BCC19 test kit achieved 100% positive and negative detection accuracy during FDA testing with comparable results and limits of detection to RT-PCR laboratory equipment. Leveraging DetectaChem’s experience in fully-integrated mobile solutions, the BCC19 test kit is also offered in a variety of Mobile Field Lab (MFL) configurations which contain up to 960 tests and all components needed for nasal or oral sampling and analysis in a single ruggedized and lightweight case. Press release.