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Antibody Detection in Seconds, AI Screening Tool Launches, Racial Inequalities in Testing: COVID-19 Updates

January 15, 2021 I Princeton University spin-off launches AI COVID screening tool, new antibody test helps select donor blood samples for therapeutic use, concerns raised over UK’s rollout of rapid asymptomatic testing, guidelines for elective surgery after infection, predicting risk of deterioration, and Wuhan study finds symptoms linger for many. Plus: FDA grants EUA for high-volume antigen test and asymptomatic testing, new simplified COVID-19 testing method, and nanomaterial-based biosensing platform detects COVID-19 antibodies in seconds.


Research News

A new SARS-CoV-2 antibody test, developed by researchers in Argentina, helps select donor blood samples for therapeutic use. The versatile test measures antibody responses to COVID-19 by detecting IgG and IgM antibodies against the whole spike protein and its receptor binding domain (RBD). According to their study, published in PLOS Pathogens, antibodies were detected in at least 34% of patients within seven days and in 95% of patients within 45 days after symptom onset. The researchers also developed standardized protocols that were used to assess IgG antibody levels to select suitable blood samples from donors who have recovered from the coronavirus for therapeutic use and clinical trials across the country. Using this protocol, approximately 80% of donor blood samples were potentially suitable for therapies. DOI:10.1371/journal.ppat.1009161

Florida Atlantic University (FAU) researchers have developed a simplified COVID-19 testing method that has a distinct advantage over the standard viral or universal transport medium. The protocol, published in PLOS ONE, can detect minimal quantities of SARS-CoV-2 using samples from both upper respiratory tract swabs (nasal and throat) as well as saliva, and the researchers say it can be used in laboratories with minimal molecular biology equipment and expertise. They believe the high sensitivity of the new protocol could be useful in testing patients with low viral titers. The method pools several patient samples which would allow for more widespread testing with less assays required. DOI:10.1371/journal.pone.0244271

The UK government’s plans to widen the roll out of the Innova lateral flow test without supporting evidence poses risk of serious harm, according to an opinion article published in The BMJ. Authors of the paper state that mass testing could be beneficial under certain circumstances if delivered to high quality, but they believe the Innova lateral flow test is not fit for this purpose. They reference the Liverpool pilot study that showed 60% of infected individuals without symptoms went undetected, including 33% of those with high viral loads, and among students in Birmingham, only 3% of those who tested positive on the ‘gold standard’ PCR test were detected. The authors call on the government to pause the rollout of rapid asymptomatic testing using the Innova test, including its use in care homes, schools, communities and self-testing by untrained people at home until clearer messaging on the risks of negative results can be developed. They also ask for full documentation relating to Innova’s approval and for publication of full reports for all studies and models of the Innova test. DOI:10.1136/bmj.n81

Oregon Health & Science University has published protocol to prepare patients for elective surgery following COVID-19 infection, which is believed to be the first of its kind. The researchers sought out to create these guidelines to ensure surgery would be safe for these patients. They looked to data published worldwide about health outcomes of patients who underwent surgery following illness and adopted a set of guidelines based on this research. Some key recommendations include a minimum recovery time for COVID-positive patients, a thorough evaluation to determine whether a patient has returned to their “pre-COVID” baseline health, and guidance for specific tests prior to surgery. The researchers note that this protocol does not account for patients who are suffering from ‘long-COVID’. This protocol is published in Perioperative Medicine. DOI:10.1186/s13741-020-00172-2

Saliva sampling could be a similarly sensitive, less costly alternative to nasal swabs for COVID-19 testing, according to McGill University researchers. The researchers summarized evidence comparing the sensitivities of detection for SARS-CoV-2 infection between nasopharyngeal swabs and saliva samples and found saliva sampling to be just as sensitive and less expensive than nasopharyngeal swabs for collection of clinical samples for COVID-19 testing. They believe using this alternative testing could address many barriers associated with nasal swabs. This article is published in the Annals of Internal Medicine. DOI:10.7326/M20-6569

In a new study of over 1,700 patients hospitalized in Wuhan, China with COVID-19, researchers found that 76% of those patients reported at least one symptom six months after initial infection. The most common symptoms to persist were fatigue or muscle weakness (63%), difficulty sleeping (26%), and anxiety or depression (23%). The researchers conducted face-to-face interviews with the COVID-19 patients, all who were discharged from Jin Yin-tan Hospital in Wuhan between January and May 2020, to evaluate their symptoms and quality of life. The patients also underwent physical examinations, lab tests, and a six-minute walking test to measure endurance. Those with more severe disease commonly had reduced lung function and performed worse in the walking test. The researchers suggest that those patients with severe COVID-19 infection receive post-discharge care and that long-term research be conducted to better understand the lasting effects of the virus. This study is published in The Lancet. DOI:10.1016/S0140-6736(20)32656-8

Racial inequalities in COVID-19 testing between White and Black communities have been quantified using Lorenz curves in a new study published in JAMA Network Open. Washington University researchers examined testing disparities across seven counties in the St. Louis region using data on all COVID-19 tests conducted in Missouri from the State Public Health Department. They combined this information with data on hospitalizations in the region and individual factors, which included location, age, and race. Researchers generated modified Lorenz curves to assess COVID-19 testing relative to disease burden and found that only 22.9% of tests were conducted in the 23 zip codes accounting for 50% of hospitalizations. In 17 of these zip codes, Black individuals accounted for over half of the demographic. In contrast, 52.9% of tests were conducted in zip codes that accounted for only 25% of hospitalizations and all those zip codes were predominantly White. The researchers suggest scaling up testing in areas with the highest disease burden to address these gaps and racial disparities. DOI:10.1001/jamanetworkopen.2020.32696

Researchers from the UK Coronavirus Clinical Characterization Consortium, or ISARIC4C, have developed an online tool that can accurately predict which adult patients hospitalized with COVID-19 are at risk for deterioration. The tool was developed using data from nearly 75,000 patients with COVID-19 admitted to 260 hospitals across the United Kingdom between February and August 2020. Researchers tested 11 measurements that are routinely collected from patients against the patient cohort to establish how and to what degree each of those measurements affected the likelihood of deterioration. Using these 11 measurements, along with standard laboratory tests, the tool calculates a percentage risk of deterioration, known as the ‘4C Deterioration Score’. The researchers report that their analysis provides evidence that the 4C Deterioration tool could be useful for clinicians across England, Scotland, and Wales to support clinicians’ decision making and help improve patient outcomes. DOI:10.1016/S2213-2600(20)30559-2

A new nanomaterial-based biosensing platform detects COVID-19 antibodies in seconds, and the platform could be used to quantify patient immunological response to new COVID-19 vaccines with precision. Researchers from Carnegie Mellon University report that this testing platform identifies the presence of spike S1 protein and RBD in a tiny drop of blood and detects antibody concentrations at extremely low levels. Detection happens through an electrochemical reaction within a handheld device that sends results to a simple interface on a smart phone almost instantly. Nanoparticle 3D printing was utilized to create the device. The test is highly accurate and because the proposed sensing platform is generic, it can be used for the rapid detection of biomarkers for other infectious diseases, according to the researchers. This work is published in Advanced Materials. DOI:10.1002/adma.202006647

Thousands of Wuhan residents were infected with asymptomatic cases of COVID-19 after the infection was declared to be under control in China. Researchers tested more than 60,000 healthy individuals for SARS-CoV-2 antibodies and studied the prevalence of IgG and IgM antibodies in the blood samples, which were collected between March and May 2020. The percentage of people with positive SARS-CoV-2 antibodies was approximately 1.68%. This number was significantly higher than in other regions of China where antibody positivity rate was 0.38% on average. According to the IgM positivity rate (0.46%) in Wuhan, the researchers estimate that thousands of people had asymptomatic cases between March and May 2020, although there were not clinically reported cases of COVID-19. The researchers warn that avirulent SARS-CoV-2 strains could still cause symptoms in those who are extremely susceptible, and it may also revert to a highly virulent strain. These findings are published in PLOS Neglected Tropical Diseases. DOI:10.1371/journal.pntd.0008975


Industry News

PerkinElmer announced that the company’s New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for asymptomatic testing of COVID-19. The PerkinElmer test kit, which was deemed the most sensitive assay by the FDA among authorized COVID-10 molecular diagnostic tests, originally obtained FDA EUA in the spring of 2020. It is also approved for sample pooling. Press Release

EUROIMMUN, a PerkinElmer company, has launched a SARS-CoV-2 Interferon Gamma Release Assay (IGRA) for Research Use Only (RUO) to determine the activity of T-cells reactive to SARS-CoV-2. This latest addition to EUROIMMUN’s COVID-19 specific product portfolio will allow researchers to study immune responses to the coronavirus with well-established ELISA technology. Press Release

Ortho’s VITROS SARS-CoV-2 Antigen Test has become the first high-volume COVID-19 antigen test to receive EUA from the FDA. With utility for mass-scale testing and same-day results for labs, Ortho’s newest COVID-19 solution can run up to 130 tests per hour. It has already received a CE Mark and has been shipping in the EU and U.S. under an Emergency Use Notification (EUN). The test is run on Ortho’s high-volume VIRTROS Systems, which are installed in over 5,600 laboratories around the world with 1,500 installed in the U.S. Press Release

Children’s National Hospital has unveiled the 10 top artificial intelligence (AI) models from the COVID-19 Lung CT Lesion Segmentation Grand Challenge, which is a competition focused on developing AI models to identify COVID specific lesions in the lungs of infected patients. The competition attracted over 1,000 participants around the world and was presented in collaboration with NVIDIA and the National Institutes of Health (NIH). The competition’s AI models utilized a multi-institutional, multi-national data set provided by public datasets from The Cancer Imaging Archive (National Cancer Institute), NIH, and the University of Arkansas. In addition to an award, the winning algorithms are now available to partner with clinical institutions across the globe to further evaluate how these quantitative imaging and machine learning methods may potentially impact global public health. Press Release

NeuTigers, an AI company spun out of Princeton University, has launched CovidDeep, a clinically validated technology that uses physiological sensors data to detect potential SARS-CoV-2 infection with over 90% accuracy. The screening tool uses advanced algorithms of machine learning to detect physiological patterns even before they are felt by the patients with real-time analysis. Users answer a questionnaire regarding symptoms and health history and input their health sensor’s data. Data is entered by connecting CovidDeep to a wearable device, an Empatica E4 Wristband, as well as inputting blood pressure and oxygen readings using any off-the-shelf device. CovidDeep analyzes this data in approximately two minutes and provides a prediction as to whether someone is likely to be negative or positive for COVID-19. This screening tool is now available globally. Press Release

New England Biolabs (NEB) has announced the launch of its Luna SARS-CoV-2 RT-qPCR Multiplex Assay Kit for real-time detection of SARS-CoV-2 nucleic acid. This RUO kit offers multiplex testing of up to 94 samples in a single 96-well plate, with the additional capacity for supporting sample pooling and high throughput applications using 384-plate test formats. This new assay addresses gaps with more sensitive N2 detection and unique internal controls. Press Release

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