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‘Pooling’ Test Samples and Dipstick Technology, Persistent Symptoms During Pregnancy, At Home Finger Prick Test: COVID-19 Updates

October 09, 2020 | New ‘dipstick’ technology developed at the University of Queensland can quickly extract genetic material in as little as 30 seconds; CalTech researchers develop new sensor named SARS-CoV-2 RapidPlex; and dried blood spot samples are as accurate in detecting SARS-CoV-2 antibodies as venous blood samples study finds. Plus: NIH announces new RADx initiative contracts totaling  $98.35 million; University of Minnesota AI evaluates chest X-rays to diagnose COVID-19; Boston launches TestBoston to track previous infection; and more.


Research Updates

86% of UK residents who tested positive for COVID-19 between April 26 and June 27 did not have the specific virus symptoms (cough, fever, or loss of taste/smell) according to a new study led by UCL researchers and published in Clinical Epidemiology. Data was used from the Office for National Statistics Coronavirus Infection Survey pilot study and looked at 36,061 people. They found that of those surveyed, 115 tested positive for SARS-CoV-2 (0.32%) and of those who tested positive, only 16 (13.9%) reported specific virus symptoms. The study also included data on people reporting a wider range of symptoms such a fatigue and shortness of breath, and of those who tested positive, 27 (23.5%) were symptomatic and 88 (76.5%) were asymptomatic on the day of the test. The authors did note that several studies have highlighted a lower proportion of SARS-CoV-2 positive individuals are asymptomatic, however, the prevalence of asymptomatic cases varies greatly possibly due to the sampling and settings of the study. DOI: 10.2147/CLEP.S276825

In the largest study to date on COVID-19 among non-hospitalized pregnant women, researchers analyzed the clinical course and outcomes of 594 women who tested positive for SARS-CoV-2 virus during pregnancy. They found the most common early symptoms were cough (20%), sore throat (16%), body aches (12%), and fever (12%). Half of the participants still had symptoms after 3 weeks and 25% had symptoms persisting after 8 weeks or more. The findings from this PRIORITY study (Pregnancy Coronavirus Outcomes Registry) appear in Obstetrics & Gynecology and note that the majority of participants had mild disease and were not hospitalized, but it took a median of 37 days for symptoms to ease. This national study was led by UC San Francisco and UCLA. doi: 10.1097/AOG.0000000000004178

Most COVID-19 cases in Southern California early in the pandemic are linked to New York state via Europe, not directly from China. These finding were based of a genetic analysis of the virus found in tissue samples from 192 patients diagnosed with the SARS-CoV-2 virus at Cedars-Sinai. The study, published in JAMA Network Open, found that about 15% of the samples taken between March 22 and April 15 were genetically similar to published profiles of SARS-CoV-2 viruses from Asia, while 82% shared close similarities with variants originating in Europe. DOI: 10.1001/jamanetworkopen.2020.24191

A mathematician from Cardiff University as developed a new method for processing large volumes of COVID-19 tests using simple algebraic equations, as published in Health Systems. This technique, known as ‘pooling’, involves grouping a large number of samples from different patients into one test tube and performing a single test on that tube. If the tube is negative then every patient from that group does not have the virus, and if a tube is returned positive then each patient from that group needs to be tested individually. This method works well when the overall infection rate in a population is expected to be low, however, it can be applied to populations with high infection rates to reduce testing times drastically. DOI: 10.1080/20476965.2020.1817801

New ‘dipstick’ technology, developed at the University of Queensland, can quickly extract genetic material in as little as 30 seconds and provides a full molecular diagnosis in 40 minutes. This new technology enables the purification of DNA and RNA nucleic acids from patient samples, which is a critical step in COVID-19 diagnosis. Combined with a portable diagnostic machine that they have developed that fits in your hand and can be powered by a car’s cigarette lighter connection, this could enable faster identification and isolation of COVID positive patients. The researchers said that their dipsticks can be produced quickly, cheaply and in bulk using a household pasta maker, adding that it was quite a surprise. The researched has been published in Nature Protocols. DOI: 10.1038/s41596-020-0392-7

Dried blood spot samples (DBS) are as accurate in detecting SARS-CoV-2 antibodies as venous blood samples, a new study by immunology experts at the University of Birmingham has found. Relative to serum samples, DBS samples achieved 98% sensitivity and 100% specificity for detecting anti-SARS-CoV-2 S glycoprotein antibodies. 100% of the PCR-positive samples were also antibody-positive in DBS. DBS sampling is simple, inexpensive and can be self-collected by the patient at home using a finger prick. This offers possibilities to widen access to antibody testing particularly in more resource limited countries. These findings are published in Emerging Infectious Diseases. DOI: 10.3201/eid2612.203309

Researchers from California Institute of Technology have developed a rapid COVID-19 test that measures early infection, immunity, and severity. This multiplexed test with a low-cost sensor may enable at-home diagnosis using small amounts of saliva or blood in less than 10 minutes. This new sensor, named SARS-CoV-2 RapidPlex, has shown high accuracy in preliminary results, but a larger-scale test with real world patients must be performed. Their ultimate aim is at home use with plans to mail them to high-risk individuals for at-home testing in the coming year. The paper describing this research has been published online and will appear in the December issue of the journal Matter. DOI: 10.1016/j.matt.2020.09.027

A team of scientists at the University of Vermont developed a two-step method of testing for the COVID-19 virus that does not require reagents, or chemicals needed for the standard reverse transcription polymerase chain reaction (RT-PCR) test. The method for this test, published in PLOS Biology, omits the step where reagents are needed. A major roadblock to large scale testing for the coronavirus infection in the developing world, and even in industrialized nations like the United States, is a shortage of this chemical. The accuracy was evaluated by a team of researchers at the University of Washington and found it to correctly identify 92% of positive samples and 100% of the negatives. Given its low cost and efficiency, the goal is to increase global testing capacity. DOI: 10.1371/journal.pbio.3000896

A research team at the National Institute of Standards and Technology (NIST) has developed a way to increase sensitivity of the primary test used to detect SARS-CoV-2 virus. The results published in Analytical and Bioanalytical Chemistry describes a mathematical algorithm that can perceive comparatively faint signals that can escape detection when the number of viral particles found in a patient’s nasal swab test sample are low. Data from a positive test, when expressed in graphical form, takes on a recognizable shape that is always the same. This technique recognizes this shape, regardless of size or location, that could make the swab test up to 10 times more sensitive. The new test would be unlikely to generate false positives or negatives. Preliminary studies show the rate of false negatives may be as high as 30% in nasal swab testing without the use of this algorithm. DOI: 10.1007/s00216-020-02930-z

SENSR (SENsitive Splint-based one-pot isothermal RNA detection) technology developed by a joint research team at Pohang University of Science & Technology (POSTECH) allows anyone to easily and quickly diagnose COVID-19 based on the RNA sequence of the virus. This technology can diagnose infections in just 30 minutes. POSTECH researchers designed the test kit to produce nucleic acid binding reaction to show fluorescence only when COVID-19 RNA is present. Therefore, the virus can be detected without any preparation process and as accurately as the current PCR diagnostic method. The biggest benefit is that a diagnostic kit can be developed within a week, even if a new infectious disease appears. This study was published in Nature Biomedical Engineering. DOI: 10.1038/s41551-020-00617-5

Brain fog’ and other neurological symptoms after COVID-19 may be due to post-traumatic stress disorder (PTSD). A review of data from the SARS and MERS outbreaks showed that survivors had heightened risk for PTSD and symptoms from this may arise in response to invasive measure needed, including intubation and ventilation, to treat some COVID-19 patients. Frontline health-care workers can be similarly affected due to constant stress and fear they face at work. Researchers are still working to understand the direct neurological effects of COVID-19. This co-authored paper was published in The Clinical Neurophychologist. DOI: 10.1080/13854046.2020.1811894

A global network study including more than 34,000 patients hospitalized with COVID-19 found that these patients were more likely male, younger, and (in both the US and Spain) had fewer comorbidities and lower medication use than those hospitalized with influenza. Many of the COVID-19 patients hospitalized did have other health conditions, such as hypertension (24-70%), diabetes (13-43%), and asthma (4-15%), but despite this, when compared to patients hospitalized with influenza in recent years, those with COVID-19 were seen to generally be healthier. COPD, CV disease and dementia were all more common among hospitalized influenza patients. This study initiated by the Observational Health Data Sciences and Informatics (OHDSI) community was published in Nature Communications. DOI: 10.1038/s41467-020-18849-z


Industry Updates

A new artificial intelligence (AI) algorithm developed and validated by researchers at the University of Minnesota can evaluate chest X-rays to diagnose probable cases of COVID-19. To train the algorithm to diagnose COVID-19, the team at M Health Fairview used 100,000 X-rays of patients who did not have COVID-19 and 18,000 of patients who did. Today, all 12 M Health Fairview hospital used this new algorithm and it will be available at no cost to other health systems through Epic software. Patients get treated sooner and prevent unintentional exposure with this new advance. Press Release

NIH working in collaboration with BARDA announced a third round of contract awards for scale-up and manufacturing of new COVID-19 testing technologies. The six new RADx initiative contracts total $98.35 million for point-of-care and other novel test approaches. Innovations include integration with smart devices, mobile-lab processing that can be deployed to COVID-19 hot spots, and test results available within minutes. The RADx Tech program is focused on rapidly advancing early testing technologies and contracts are expected to increase testing capacity by 2.7 million per day by the end of 2020. Press Release

The UK government has entered into contract with Abingdon Health and placed its first order for supply of one million COVID-19 rapid antibody tests. The antibody test will be rolled out under the government’s COVID-19 surveillance studies to build a swift and clear picture of how the virus has spread throughout the UK population. It will also help establish the effectiveness of any vaccine which provides protection by creating new antibodies. Press Release

Clinicians and researchers from Brigham and Women’s Hospital, the Broad Institute of MIT and Harvard, and the MGB Center for COVID Innovation are launching TestBoston, a large-scale research study to detect active COVID-19 cases and evidence of previous infection. Over the course of six months, participants will be sent monthly at-home test kits for viral and antibody testing. The study aims to detect when clusters of COVID-19 are on the rise again throughout the fall and winter in the greater Boston area and learn more about whether prior infection provides any protection against subsequent re-infection. TestBoston will invite participation of patients who have been seen at any Brigham site within the past year and live within a 45-mile radius of Boston. Press Release

A new COVID-19 rapid-testing technology platform developed by Rover Diagnostics and Columbia Engineering has been selected by the National Institutes of Health (NIH) to advance to Phase 1 of the Rapid Acceleration of Diagnostics (RADx) initiative. The Rover team is among only 33 companies that made the cut to advance to a rigorous four-week period of initial technology validation, manufacturing, and delivery to the marketplace. This affordable, portable point-of-care (POC) platform provides results in eight minutes, faster than any test of its kind. It will be targeted to locations where rapid turnaround results are important: for example, at pharmacies, transportation hubs, public events, and at companies screening employees. Press Release

Harvard Wyss Institute’s nasal swab and toehold switch technologies have been licensed to Agile Biodetection, which will use them to develop solutions for unmet diagnostic needs in detecting the SARS-CoV-2 virus in environmental and clinical settings. The Wyss swab device is fully injection-molded from a single material, as opposed to two, that can be mass manufactured in a one-step process that is faster and less expensive. Toehold switches offer versatile capabilities in detecting the presence of pathogens with high sensitivity and specificity in environmental settings. Agile Biodetection is focusing on detecting SARS-CoV-2 in the environment, including surfaces and touchpoints within high-traffic areas. They believe that 3-pronged testing of individuals, surfaces, and the environment will provide a leading indicator of the risk of infection. Press Release

The Chicago Center for HIV Elimination has been awarded $5 million through the National Institute of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Underserved Populations program to support a COVID-19 testing project across eight rural and urban sites in the Central United States. Two disenfranchised populations targeted by this initiative face some of the highest COVID-19 infection and death rates in the U.S. The testing approach combines an evidence-based Social Network Testing Strategy (SNS) with community developed COVID-19 public health messages. Their goal is to evaluate these approaches for their effectiveness at increasing testing rates and improving contact tracing within the community, which then improves diagnosis and treatment in these underserved populations. Press Release

Clarigent Health, a mental health technology company, launched an app-based listening tool, Clarity, that analyzes speech with artificial intelligence (AI) trained to identify patients at risk of suicide. Clarity provides an additional objective metric to identify risk amid a mental health crisis linked to stress, anxiety and isolation due to the COVID-19 pandemic. The tool is compatible with telehealth platforms when mental health professionals are unable to look for signals in a face to face environment. Press Release

Children tested for COVID-19 using a polymerase chain reaction (PCR) test prior to receiving anesthesia saves extensive personal protective equipment (PPE). The research presented by the American Society of Anesthesiologists at the ANESTHESIOLOGY 2020 annual meeting showed a reduction of 70% in wearing expanded PPE when using PCR testing instead of a verbal screening. This links the importance of universal COVID-19 testing to save extensive PPE when not needed and to enhance safety benefits in other treatment centers. Press Release

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