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COVID-19’s Impact On Diagnostics, And Other News

May 15, 2020 | Due to fears over COVID-19, fewer people are being evaluated for signs of stroke, according to a recent study from Washington University School of Medicine. A King’s College London, Massachusetts General Hospital, and ZOE team-developed AI diagnostic may predict whether someone has COVID-19 based on symptoms. An amended emergency use authorization from the FDA for the first at-home saliva collection test for SARS-CoV-2 from RUCDR Infinite Biologics. We round up the week’s research and industry news for COVID-19.

Literature Updates | 

Researchers from the University of Cincinnati and Kantonsspital Aarau (Switzerland) have found that loss of the sense of smell is most likely to occur by the third day of COVID-19 infection, and that most of these patients also experience a loss of the sense of taste. Findings were based on a telephone survey of 103 patients diagnosed with the novel coronavirus over a six-week period at the Switzerland hospital. At least 61% of those patients reported reduced or lost sense of smell, with a mean onset of 3.4 days. Severity of anosmia also correlated with severity of other symptoms, including shortness of breath and more severe fever and cough. Additionally, researchers found that younger patients and women were also more likely to experience a decreased loss of smell. Half of study patients experienced a stuffy nose and 35% a runny nose, suggesting these symptoms may be attributable to COVID-19 and not allergy. The study’s principal investigator says the antiviral drug remdesivir, developed by Gilead Sciences to initially treat Ebola, is showing some promise in treating COVID-19 patients. Findings to publish in Otolaryngology-Head and Neck SurgeryManuscript accepted for publication. 

The number of people evaluated for signs of stroke at U.S. hospitals dropped by nearly 40% during the COVID-19 pandemic, according to a study by researchers from Washington University School of Medicine in St. Louis and Stanford University who analyzed stroke evaluations at more than 800 hospitals across 49 states and the District of Columbia. The findings, which published in the New England Journal of Medicine, are a troubling indication that many people who experience strokes may not be seeking potentially life-saving medical care. Between February (before the pandemic) and a two-week period from March 26 to April 8 when much of the country was under shelter-in-place orders, use of RAPID—software used to analyze brain scans so doctors know what kind of stroke has occurred—fell by 39%. The drop was large even in places where COVID-19 cases were few and hospitals were not overwhelmed. The risk of delaying care for a stroke is much greater than the risk of contracting COVID-19, and the effect of coming in too late is the same in many respects as not coming in at all, researchers point out. DOI: 10.1056/NEJMc2014816 

Reporting in Frontiers in Medicine, scientists in Europe have found that a commercially available, 15-minute disposable antigen test for detecting COVID-19 infections could be useful as part of a broader triage strategy for slowing down the virus. The two-phase study examined the sensitivity and specificity of the new test during its development stage in the lab and later using real-world biological samples from more than 300 previously infected patients. Overall accuracy was 82 percent in the latter setting, with an overall sensitivity of 57.6 percent and an overall specificity of 99.5 percent. The COVID-19 Ag Respi-Strip test, developed by Belgian company Coris BioConcept, is a lateral flow test that uses a sample from a nasopharyngeal swab. Because it is quicker, cheaper and less complicated (though not as sensitive) as reverse transcription-polymerase chain reaction (RT-PCR) assays, the authors say the test could help screen patients during peak periods of the pandemic and higher-risk populations such as healthcare workers. They estimate it could reduce the number of laboratory tests using RT-PCR by more than 13 percent. DOI: 10.3389/fmed.2020.00225 

Although the clinical symptoms of COVID-19 pneumonia may be nonspecific, some characteristic imaging findings are emerging that can allow radiologists to differentiate it from other lung disorders in pediatric patients, according to research published in the American Journal of Roentgenology. For optimal patient care, the authors suggest careful evaluation of the distribution, lung zone preference and symmetry of abnormalities with an eye for a few unique differentiating imaging features, such as the halo sign seen in COVID-19. Limited studies of pediatric patients with COVID-19 have noted that chest radiography may show normal findings, patchy bilateral ground-glass opacity (GGO), consolidation—or both—with peripheral and lower lung zone predominance. Only a few articles have reported CT findings of COVID-19 in children; one reported that the most frequently observed abnormalities were subpleural lesions (100% of patients), unilateral (30%) or bilateral (50%) pulmonary lesions, GGO (60%), and the distinct halo sign (50%). DOI: 10.2214/AJR.20.23267 

Patients with COVID-19 can have bowel abnormalities, including ischemia, according to study published in Radiology. The retrospective study included 412 patients consecutively admitted to Massachusetts General Hospital from March 27 to April 10, 2020, who tested positive for SARS-CoV-2. Records showed 17% of patients had cross-sectional abdominal imaging, including 44 ultrasounds, 42 CT scans and one MRI. Bowel abnormalities were seen on 31% of CT scans (3.2% of all patients) and were more frequent in intensive care unit patients than other inpatients. Bowel findings included thickening and findings of ischemia such as pneumatosis (gas in the bowel wall) and portal venous gas. Surgical correlation in four patients revealed unusual yellow discoloration of bowel in three of the patients, and bowel infarction (dead bowel) in two patients. Possible explanations for the spectrum of bowel findings include direct viral infection, small vessel thrombosis or nonocclusive mesenteric ischemia, according to the researchers. DOI: 10.1148/radiol.2020201908 

new diagnostic approach developed to track malaria and assist in eliminating deadly relapses could also provide vital information about a community's immunity to COVID-19. The test analyses a blood sample to reveal immune markers that indicate whether, and when, a person was exposed to infection. Its potential to enhance infectious diseases surveillance, particularly in lower income countries, was described in Nature Medicine. The research team hailed from the Walter and Eliza Hall Institute (Australia), Pasteur Institute (France) and Ehime University (Japan). They have already started to study the blood of people who have had COVID-19 infections to document the types of antibodies they carry and, in the next six months, hope to have discovered how these antibodies change over time. DOI: 10.1038/s41591-020-0841-4 

Also appearing in Nature Medicine are findings of researchers at King's College LondonMassachusetts General Hospital and health science company ZOE using an artificial intelligence (AI) diagnostic they developed that can predict whether someone is likely to have COVID-19 based on their symptoms. The AI model uses data from the COVID Symptom Study app (3.3 million downloads globally) to predict COVID-19 infection, by comparing people's symptoms and the results of traditional COVID tests. Two clinical trials in the U.K. and U.S. are due to start shortly. In this study, researchers analyzed data from just under 2.5 million people who had been regularly logging their health status in the app, around a third of whom had logged symptoms associated with COVID-19. Of these, 18,374 reported having had a test for the coronavirus, with 7,178 people testing positive. Findings included a wide range of symptoms relative compared to cold and flu, with researchers warning against focusing only on fever and cough. Particularly striking was that two-thirds of users testing positive for coronavirus infection reported loss of taste and smell (anosmia) compared with just over a fifth of the participants who tested negative. That suggests anosmia is a stronger predictor of COVID-19 than fever. The team created a mathematical model that predicted with nearly 80% accuracy whether an individual is likely to have COVID-19 based on their age, sex and a combination of four key symptoms—loss of smell or taste, severe or persistent cough, fatigue and skipping meals. Applying this model to the entire group of over 800,000 app users experiencing symptoms predicted that just under a fifth of those who were unwell were likely to have COVID-19 at that time. DOI: 10.1038/s41591-020-0916-2 

Researchers in China have developed and validated a clinical risk score to predict the occurrence of critical illness in hospitalized patients with COVID-19. As described in JAMA Internal Medicine, the risk score (COVID-GRAM) uses 10 independent predictors: chest radiography abnormality, age, hemoptysis, dyspnea, unconsciousness, number of comorbidities, cancer history, neutrophil-to-lymphocyte ratio, lactate dehydrogenase and direct bilirubin. The development cohort included 1590 patients and the validation cohort 710 patients, from 575 hospitals across China. An online calculator was developed based on COVID-GRAM. DOI: 10.1001/jamainternmed.2020.2033 

In a paper published in Med, a team of investigators from Boston University School of Medicine and Boston Medical Center outline how they converted their lab to test patient samples for SARS-CoV2 and provide a blueprint for other labs that want to do the same thing. Among the challenges was adapting the lab to the strict policies required to run a Clinical Laboratory Improvement Amendments-certified, College of American Pathologists-accredited diagnostic lab. The team requested and received emergency permission from the FDA to repurpose the lab and began operating in less than a week. As of April 20, 2020, they had already tested more than 3,000 samples with a turnaround time of under 24 hours. Nearly 45% of those tests were positive. The “home-brew” assay was designed to use different reagents at each step of the process to eliminate potential supply chain issues. The team is now looking at expanding to other kinds of assays, including saliva-based tests. DOI: 10.1016/j.medj.2020.05.001 

Children suffering from sickness and diarrhea, coupled with a fever or history of exposure to coronavirus, should be suspected of being infected with COVID-19, recommends a study published in Frontiers in Pediatrics by researchers in China. The research also suggests that the gastrointestinal symptoms first suffered by some children hints at potential infection through the digestive tract, as the type of receptors in cells in the lungs targeted by the virus can also be found in the intestines. In this study, researchers detail the clinical features of children admitted to the hospital with non-respiratory symptoms (e.g., kidney stone, head trauma), which were subsequently diagnosed with pneumonia and COVID-19. Importantly, four of the five COVID-19 cases had digestive tract symptoms as the first manifestation of the diseaseDOI: 10.3389/fped.2020.00258 

Mount Sinai researchers report in Radiology that chest X-rays performed on young and middle-aged adults with COVID-19 when they arrive at the emergency room can help doctors predict who is at higher risk of severe illness and intubation. Their unique severity scoring system divides the lungs into six zones with scores based on what has historically happened to patients as the disease progressed or resolved. Radiologists analyzed records of 338 COVID-19-positive patients (average age 39 and 62% male) at three Mount Sinai hospitals between March 10 and March 26, including information on race and pre-existing conditions, all of whom had an X-ray taken in the emergency room. The total score depended on how many zones disease showed up in; lower severity scores ranged from zero to two, and higher severity from three to six. Of the 338 patients, 145 were admitted. Patients with highest chest X-ray scores were 6.2 times more likely to require hospitalization, and 4.7 times more likely to be intubated. Men were more likely than women to have higher chest X-ray scores and be admitted but were not more likely to be intubated. Obese patients were also more likely to have higher chest X-ray scores and require hospitalization. No significant differences in outcomes were found between patients of different race and ethnicity when adjusted for other factors such as age, gender, comorbid medical conditions and weight. DOI: 10.1148/radiol.2020201754 

Other News | 

Scientists worldwide have united as the Global Consortium of Chemosensory Researchers (GCCR) to investigate the connection between the chemical senses and the COVID-19 virus. The group is urging anyone who has recently experienced symptoms of respiratory illnesses or smell loss to complete a 10-minute survey, which has been translated into more than 20 languages. The data will be used to unravel key markers of the virus to further understand how to prevent its spread. GCCR includes more than 600 clinicians, neurobiologists, data scientists, cognitive scientists, sensory researchers and technicians from over 50 countries. Members are inviting patient and public involvement in the GCCR through its Patient Advocacy Committee. Press release

Avacta Group, the developer of Affimer biotherapeutics and reagents, is pleased to announce it is shipping Affimer reagents for COVID-19 antigen testing to its diagnostic test development partners. The Group recently reported that it had generated multiple, highly specific Affimer reagents that bind the SARS-COV-2 viral antigen and do not cross-react with SARS, MERS and other closely related coronaviruses. These Affimer reagents will be used to develop a point-of-care saliva based COVID-19 antigen test strip by Cytiva (formerly GE Healthcare Life Sciences) for CE marking in Europe and FDA approval in the United States. Press release.  

Parexel has deployed nearly 30 employee volunteers to help administer and oversee COVID-19 testing across the UK in partnership with the Association of Clinical Research Organizations (ACRO). The Parexel volunteers are among a team of 150 individuals with medical and clinical expertise from clinical research and technology organizations who are responding to ACRO’s call to administer throat and nasal swab tests at COVID-19 testing centers throughout the UK. Parexel volunteers include doctors, nurses, laboratory professionals and clinical scientists from the UK team, including the Early Phase Clinical Units (EPCUs), who will serve as trainers and validators to ensure the accuracy of procedures within testing sites. Press release.  

University of Utah electrical and computer engineer is developing a portable, reusable coronavirus sensor. The sensor is about the size of a quarter, works with a cellphone and can reportedly detect COVID-19 in 60 seconds from just a drop of saliva. The project is being supported by a $200,000 National Science Foundation Rapid Response Research grant. According to The COVID Tracking Project, no more than 319,000 COVID-19 tests per day are currently being conducted, far fewer than the five million minimum health officials say the U.S. needs to effectively understand and contain the spread of the virus. The new technology, which was recently profiled in two papers published in IEEE Sensors Journal, is based on a sensor under development to detect the Zika virus. The sensor would include an array of tiny devices, each with a DNA strand that looks for a different protein associated with COVID-19. To use, people would plug the small sensor into their phone's power jack and launch an app made for the device. The sensor could be reused because it can destroy previous samples on it by producing a small electrical current. A prototype of the new COVID-19 sensor could be ready for clinical trials in two to three months. Press release

Collective Health is introducing Collective Go, a product suite designed to help businesses and their workers reduce risk and navigate safer workforce reentry, with a measured and evidence-based approach. Collective Go includes an evidence-based, externally-reviewed occupational health protocol underpinning a testing process, tailored to address risks associated with specific job types and populations; a full ecosystem of clinically-validated or FDA EUA test options through a wide and growing network of certified lab partners; a simple, streamlined, and privacy-oriented app experience with symptom and exposure checking, test status monitoring, and certification of compliance with business workplace testing protocols; and a HIPAA-compliant platform capable of securely receiving data from a variety of testing labs, with management tools to deliver insights on how the workforce is tracking towards successful risk reduction and reentry. Tests include a diagnostic COVID-19 PCR testing solution from Everlywell and a rapid COVID-19 serology test from GenalytePress release.   

Scientists at the Moscow Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies has created the world’s largest chest CT scan database (1,000 anonymized sets) for teaching artificial intelligence (AI) algorithms to diagnose COVID-19. The studies were collected between March 1 to April 25, 2020 using the Unified Radiological Information Service, to which the diagnostic equipment of 80 Moscow healthcare institutions is connected. Unlike databases elsewhere, all CT studies in the Moscow dataset have a special marking made according to the classification published in guidelines for radiology diagnostics of COVID-19 that reflects manifestation of pathological abnormalities in the lung tissue. Studies are divided into five large groups from CT-0 (normal and absence of CT signs of viral pneumonia) to CT-4 (diffuse ground glass opacities, pulmonary parenchymal involvement more than 75%.). Experts explicitly marked 50 studies where pixels' zones of ground glass opacities and consolidations, specific for COVID-19, are indicated on each CT slice with lung tissue abnormalities—the most informative type of marking of CT scan images for AI. Press release

Rutgers University's RUCDR Infinite Biologics has received an amended emergency use authorization from the FDA for the first at-home saliva collection test for SARS-CoV-2. The assay was developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs. This comes on the heels of FDA authorization for the new collection approach, the first such approval granted by the agency, which allowed healthcare workers to collect people's saliva at testing sites. RUCDR also recently launched a genetic testing service for COVID-19, whose capacity will mushroom from thousands to tens of thousands of samples daily with the new saliva tests and expanded collection strategy. Press release

Using existing hardware and computing power of commodity smartphones, University of Pittsburgh professors are developing non-invasive at-home testing for COVID-19 infection with funding from the National Science Foundation’s RAPID award program. The device will involve new mobile sensing and artificial intelligence techniques and could ultimately be applied to other acute or chronic respiratory diseases. The development team is hopeful the work will also help identify negative cases caused by other diseases with similar symptoms, helping to eliminate unnecessary hospital visits during the current pandemic. The plan is to build upon smartphones' microphones and speakers to develop acoustic sensing that can measure changes in human airway mechanics, which are uniquely correlated to COVID-19 infection. The system will be implemented as a smartphone app that users can easily download, install and operate. Users will also need to use a smartphone adapter as a mouthpiece. Press release.