October 16, 2020 I Antibodies may provide immunity for several months, five cytokines identified that predict cytokine storm, Dublin-Boston score predicts severity of infection, pandemic related delays in CRC screening may cause significant increase in death rates from cancer, and Fluidigm to provide millions of saliva-based tests to US colleges and universities. Plus: Mount Sanai receives research funding to study impact of virus on lung cancer patients, SwabSeq has capability to test thousands of samples together but give individual results and more.
Research News
University of Southampton researchers have demonstrated a blood test for five cytokines that could predict those COVID-19 patients at risk for cytokine storm. The researchers analyzed blood samples from 100 COVID-19 patients admitted to the University Hospital Southampton during the first phase of the pandemic and found that high levels of cytokines in the patients’ blood upon admission were linked to an increased chance of needing intensive care, mechanical ventilation and death. The team hopes that by accurately identifying which cytokines drive hyperinflammation in each individual patient, treatment can be tailored to target these specific cytokines and yield better patient outcomes. These findings are published in Respiratory Research. DOI: 10.1186/s12931-020-01511-z
A new measurement, called the Dublin-Boston score, has been developed that can accurately predict which COVID-19 patients will develop severe infection. This method is published in the journal EBioMedicine and determines how severe infection will be on day seven after measuring levels of two molecules, interleukin (IL)-6 and interleukin (IL)-10, in the patient’s blood for the first four days. Based on changes in the ratio of these two molecules, the researchers developed a point system to assign a score. This study was led by researchers at RCSI University of Medicine and Health Sciences. DOI: 10.1016/j.ebiom.2020.103026
A research team, including researchers from the U.S. Army Futures Command, has collaborated to test alternative ways to measure COVID-19 antibody levels that would enable testing on a large scale. Specifically, this team looked to enzyme-linked immunosorbent assays (ELISAs) as they can be performed in almost any laboratory, which is important in emergency care centers treating critically ill patients. The researchers found that the ELISA test had an 80% or greater probability of predicting virus neutralization (VN) titers at or above the FDA recommended levels for COVID-19 convalescent plasma, thus could be used as a surrogate for screening. Another interesting finding was that the convalescent donors in their testing maintained high levels of immunity over several weeks, and that frequent plasma donations did not cause a significant decrease in antibody or VN levels. This study is published in the Journal of Clinical Investigation. DOI: 10.1172/JCI141206
University of Arizona Health Sciences researchers have found that antibodies provide immunity for several months after COVID-19 infection. The team studied the production of antibodies from nearly 6,000 infected people and saw antibodies still being produced five to seven months after SARS-CoV-2 infection. The key to this finding was looking for the creation of long-lived plasma cells, noting that previous studies have focused on only short-lived plasma cells, which provide high-quality and long-lasting immunity. These findings are published in the journal Immunity. DOI: 10.1016/j.immuni.2020.10.004
A method using holographic imaging to detect viruses and antibodies has been developed by a team of New York University scientists that has potential to assist in diagnostic testing, specifically related to COVID-19. The scientists based this test on holographic video microscopy, performed by an instrument named ‘xSight’, which uses laser beams to record holograms of test beads. These test beads are activated with biochemical binding sites that attract either antibodies or virus particles, which can change composition based on which one they are testing. The scientists note that this capability could allow development of a library of test beads that could then be combined into test kits for mixing patient samples and assist doctors in distinguishing possible diagnoses and speeding patients’ treatment. DOI: 10.1039/D0SM01351J
The first UK case of sudden and permanent hearing loss linked to COVID-19 infection has been reported in the journal BMJ Case Reports. The patient, a 45-year-old male who was admitted to intensive care and required mechanical ventilation for 30 days, developed tinnitus following his discharge from the hospital and then reported sudden hearing loss in that ear. After ruling out several possible causes, his doctor concluded that his hearing loss was associated with COVID-19 infection. SARS-CoV-2 has recently been discovered on cells lining the middle ear that are similar to cells lining the lungs where the virus typically invades. Only a handful of other cases associated with COVID-19 have been reported, including this first one in the UK. DOI: 10.1136/bcr-2020-238419
New research provides insight into COVID-19 immune response, specifically as the degree of severity and age of the patient increases, through a serology study published in Clinical and Translational Immunology. Serum samples were collected from 32 hospitalized COVID-19 patients and from 17 asymptomatic individuals who had antibodies for SARS-CoV-2, and researchers found that the level of antibodies correlated with severity of the viral infection. The patients requiring long-term ICU care had antibody levels that increased as their length of stay in the ICU increased. In addition, those patients requiring hospitalization in general had higher antibody levels compared to those who had exposure or with mild infection not requiring hospitalization. The study also noted that through serological testing, they discovered that many elderly patients (80 years and older) produced just as strong of an antibody response as the 40-year-olds in the study. DOI: 10.1002/cti2.1189
A new study, published in the Journal of the American Geriatrics Society, details how three nursing homes in Michigan kept COVID-19 activity minimal through universal DNA testing, partnership with a local medical center and advanced planning. Of the 215 residents in the three facilities, only 29 were diagnosed with COVID-19 between mid-March and late April. 10 of those residents were diagnosed during a proactive testing blitz of asymptomatic residents. Following that blitz, only one symptomatic case in each facility was reported. The facilities credit this proactive approach to Michigan Medicine, who provided COVID-19 viral DNA testing at their in-house diagnostic laboratory and provided results withing 24 hours in most cases, prioritizing the nursing home samples. DOI: 10.1111/jgs.16869
Researchers from two individual studies have detected antibodies that target SARS-CoV-2 as far out as 3 months after symptoms first began in recovering patients. Both studies found that SARS-CoV-2-specific IgG antibodies were the longest-lasting. The first study looked at antibody responses in the blood of 343 patients with COVID-19 for up to 122 days after onset of symptoms and found the spike protein-targeted IgG responses decayed slowly over a period of 90 days, with only 3 patients losing them within that timeframe. The second study similarly found that the IgG antibodies remained relatively stable, in both blood and saliva, for up to 105 days after symptom onset in 402 COVID-19 patients. Given these antibodies were detected at similar levels in both blood and saliva suggests that saliva may be an effective alternative for antibody testing. These findings are published in Science Immunology. DOI: 10.1126/sciimmunol.abe0367
Mothers are reporting increased insomnia and mild to high levels of acute anxiety related to COVID-19, a new study finds that is published in the Journal of Sleep Research. Mothers were asked to complete a questionnaire with reference to two points in time: one to two months before the COVID-19 pandemic in Israel and during confinement at home. Researchers used this self-reported data to compute a score representing the mother’s perception of change in sleep quality. Results showed that maternal insomnia during home confinement more than doubled to 23%, compared to 11% prior to the pandemic. Roughly 80% of the mothers also reported mild to high anxiety levels related to COVID-19. DOI: http://dx.doi.org/10.1111/jsr.13201
Industry News
Summit Biolabs announced a strategic collaboration with Colorado Center for Personalized Medicine to research, develop, and commercialize saliva liquid-biopsy tests for COVID-19 and detection of head and neck cancer. Summit is utilizing this saliva-based diagnostic test to help address critical challenges in COVID-19 and head and neck cancer testing. The test, named HNKlear, is a proprietary and non-invasive test that is the first of its kind that provides more effective, accurate, and earlier detection of head and neck cancer recurrence than traditional diagnostic methods. By leveraging their knowledge of saliva-based molecular diagnostics, Summit Biolabs plans to develop the first comprehensive panel of highly accurate saliva-based tests for COVID-19 infection, quantitation, and immune response. Press Release
Engineers and virologists from the University of Nevada, Reno have developed a test that rapidly detects SARS-CoV-2 using a nanotube-based electrochemical biosensor. This technology is similar to ones used in the past for detecting TB and CRC cancer, as well as detection of biomarkers for food safety. Preliminary results for the biosensor testing have proved successful and confirmed its potential for clinical application. The team plans to move on to sensor validation on actual COVID-19 patient swabs stored in the Viral Transport Medium and have applied for funding. Press Release
In a new clinical trial, UC Davis Health will test the monoclonal antibody cocktail, REGN-COV2, for its effectiveness and safety in preventing COVID-19. This antibody combination, which was recently administered to President Donald Trump as part of his treatment for SARS-CoV-2 infection, will be tested on people who have been in close contact with an infected person for no more than 96 hours before receiving it and compared to a group given a placebo in a double-blind study. The trial seeks to determine whether it can prevent infection for one month following the drug administration. Press Release
Delays in colorectal cancer (CRC) screening related to the COVID-19 pandemic has caused a significant increase in death rates for the cancer, according to new research presented at the UEG Week Virtual 2020. Researchers at the University of Bologna found that moderate (7-12 months) to large (over 12 months) delays in screening caused a 3% and 7% increase in advanced stage CRC respectively. Their model to predict the impact of CRC screening delays also showed a significant increase (11.9%) in deaths of those with stage III-IV CRC, based on survival rates at 5 years, when comparing a delay of less than 3 months to a large delay of more than 12 months. Press Release
Ottawa Public Health (OPH) is using a new method, designed by researchers at the University of Ottawa and CHEO Research Institute, to determine COVID-19 metrics in the community through testing wastewater for coronavirus RNA. A large portion of SARS-CoV-2 positive individuals shed the coronavirus in their stool, even before onset of symptoms or if they are completely asymptomatic. The team of researchers has been conducting wastewater testing five days a week and reporting their results the following morning to assist OPH in monitoring the level of COVID-19 circulating within the area and may have the potential to serve as an early warning system. Press Release
GenMark Diagnostics has received Emergency Use Authorization (EUA) from the FDA for their ePlex Respiratory Pathogen Panel 2 (RP2) that delivers results in under two hours for more than 20 viruses and bacteria that cause similar symptoms, including COVID-19, flu, bronchitis and the common cold. This fast and multiplex test will allow doctors to quickly and effectively determine if a patient is SARS-CoV-2 positive during the fall and winter months when other respiratory infections circulate. Press Release
Fluidigm Corporation announced a program to provide millions of noninvasive, saliva-based COVID-19 tests for US colleges and universities for as little as $5 per test. The company’s submission to the FDA demonstrated 100 percent agreement between their Advanta saliva test results and results from paired nasal samples tested with authorized assays. Development and implementation of the Advanta tests are supported by a $34 million contract with NIH under the agency’s Rapid Acceleration of Diagnostics (RADx) to fast-track innovative technologies that will significantly increase US testing capacity for SARS-CoV-2. Press Release
Researchers at Mount Sinai were selected to receive more than $7.3 million in funding to support serological testing advances and research on lung cancer patients, in regards to their vulnerability to COVID-19, as well as their immune response. $3.46 million from the National Cancer Institute (NCI) will be allocated to assist with NCI’s Serological Sciences Network (SeroNet) in their efforts to rapidly expand and deploy SARS-CoV-2 testing. $3.9 million from the grant will fund research to determine lung cancer patient’s antibody response to contracting COVID-19 and when they receive a vaccine for the virus, as well as study possible changes in lung tumor cells and noncancerous lung cells in these patients with COVID-19. Press Release
The Association for Molecular Pathology (AMP) has released results from their SARS-CoV-2 Testing Survey for clinical laboratories from August 2020 and found that respondents are experiencing significant staff shortages and ongoing supply chain interruptions, all while demand for diagnostic testing continues to rise. 85% of respondents had experienced staffing shortages and 55% reported a slight to significant decrease in diagnostic test availability from their laboratory. The AMP has updated their recommendations for federal, state and local governments based on this survey. Press Release
Scientists from UCLA Health have been granted EUA from the FDA for their use of SwabSeq, a new method of COVID-19 testing that uses sequencing technology. This method allows for thousands of samples to be tested at the same time and produces accurate, individual results in less than a day. SwabSeq adds a unique ‘barcode’ to each sample within the testing pool that identifies which specific sample has the virus. This technology can be applied to nasal, oropharyngeal or saliva sample collection. Press Release