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Beckman Coulter plans to launch a $4 coronavirus antigen test designed for mass screening, with the goal of shipping up to 25 million per month by March.
Researchers at UC Berkeley have developed a rapid test for SARS-CoV-2 that uses an enzyme to cleave viral RNA, initiating a fluorescent signal that can be detected using a smartphone camera, and which can provide a quantitative measurement of the level of viral particles in the sample. The test produce a result in as little as 30 minutes and does not require bulky or expensive laboratory equipment. Rapid testing is key to measuring and stopping the spread of COVID-19, but current tests, such as PCR, are time consuming and require expensive laboratory equipment, creating a bottleneck in obtaining results. Researchers have been developing alternatives, and this latest technology was rapidly repurposed when the pandemic began. Originally intended to detect HIV in blood samples, the Berkeley researchers have pivoted to allow the device to detect SARS-CoV-2 in nasal swab samples. The test relies on CRISPR-Cas, originally developed as a gene editing technology. When a pre-programmed Cas13 enzyme is added to the sample, it can cleave RNA sequences from the SARS-CoV-2 virus. This results in other nearby sequences being cleaved also, including a probe that releases fluorescent light when cleaved. The device uses a laser to excite this fluorescence and a smartphone camera can then detect the light, providing a quantitative measurement of the viral particles present in the sample. “It’s super exciting to have this quantitative aspect in the assay,” said Melanie Ott, a researcher involved in the study. “PCR is the gold standard, but you have to go through so many steps. There are huge opportunities here for pathogens and for biology in general to make RNA quantification more precise.” Strikingly, the test takes just 30 minutes. “Our study shows that we can do the detection part of this assay very quickly, making the measurement with mass-produced consumer electronics,” said Daniel Fletcher, another researcher involved in the study. “We don’t need fancy laboratory equipment.” The technology could provide a viable alternative to PCR for routine COVID-19 testing. “One reason we’re excited about CRISPR-based diagnostics is the potential for quick, accurate results at the point of need,” said Jennifer Doudna, a third researcher involved in the project. “This is especially helpful in places with limited access to testing or when frequent, rapid testing is needed. It could eliminate a lot of the bottlenecks we’ve seen with COVID-19.” See a video about the technology below. Study in Cell: Amplification-free detection of SARS-CoV-2 with CRISPR-Cas13a and mobile phone microscopy Via: UC Berkeley
Siemens Healthineers won both EU and US regulatory approval to introduce its epoc NXS Host mobile computer for the epoc Blood Analysis System. The Android smartphone provides an app-based intuitive interface that replaces the older interface that had over two dozen physical buttons and a relatively low resolution screen. The accompanying app is designed to include suggestions on how to perform various tests and is optimized to get through procedures quickly, particularly in seriously ill patients. “Effective point-of-care testing requires instruments that deliver quick results, are easy to use, and offer safeguards both for patient security and quality test results,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers in a press release. “The epoc System with the new NXS Host offers clinical workflow improvements so that frontline healthcare workers can get comprehensive critical care test results quickly and accelerate care for their patients.” In addition to an improved interface, the epoc NXS Host comes with more powerful processing capabilities and a larger built-in memory, allowing for faster workflows, automatic and secure reporting of results, and consistency during every test. “COVID-19 created an intense focus on patient and staff safety. Blood gas testing with the epoc System allowed the respiratory team to obtain samples and receive results without ever having to leave the room,” added Patricia DeJuilio, Clinical Director, Respiratory Care Services, Northwestern Medicine Central DuPage Hospital. “There was tremendous value in having results within minutes while never leaving the bedside of a critically ill patient and with COVID-19, never having to transport a sample outside of a COVID-19 safe environment, which was of critical importance to maintain everyone’s safety.” Product page: epoc Blood Analysis System (shown without the epoc NXS Host mobile computer) Via: Siemens Healthineers
Medtronic is releasing in the United States the industry’s first and only dedicated pediatric and neonatal acute dialysis machine. The Carpediem (Cardio-Renal Pediatric Dialysis Emergency Machine) has been in development for about a decade and the first in-human use was announced back in 2014. Having now received FDA marketing authorization, Medtronic is now making it available to hospitals around the country. Cincinnati Children’s Hospital Medical Center already has these installed and in use. The continuous renal replacement therapy (CRRT) device is indicated for patients between 2.5 and 10 kilograms (5.5 to 22 pounds) with acute kidney injury, or that are fluid overloaded, and requiring hemodialysis or hemofiltration therapy. Fluid overload is a common occurrence in children that undergo cardiac surgeries and acute kidney injuries can happen due to a variety of reasons. Typically, CRRT machines designed for adults are used off-label to treat neonates and young children, and the Carpediem device overcomes some of the limitations and risks associated with that approach. “CRRT procedures performed for critically ill infants using previously available technology are not optimal largely because dialysis machines available in the U.S. are not designed to treat these small, fragile patients, and can potentially expose them to many risks,” said Stuart L. Goldstein, M.D., professor of pediatrics and director, Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, in a Medtronic press release. “This new system is designed specifically for these patients which enables increased precision of neonatal CRRT treatment and, potentially, reduces these risks. We are grateful to be the first site in the U.S. with this technology to help the children in our care.” Related: CA.R.PE.DI.E.M. (Cardio-Renal Pediatric Dialysis Emergency Machine): evolution of continuous renal replacement therapies in infants. A personal journey; Continuous renal replacement therapy in neonates and small infants: development and first-in-human use of a miniaturised machine (CARPEDIEM) Via: Medtronic
Scientists at Tulane University have reported a new COVID-19 saliva test that uses a smartphone to provide results in as little as 15 minutes. Similar to technology from UC Berkeley that we reported on last week, the new test uses CRISPR technology and does not involve polymerase chain reaction (PCR) that, though accurate, is slow to deliver results. It is purportedly faster, more accurate, and easier to perform that existing gold standard PCR tests, while requiring less equipment and achieving results in minutes rather than days. The new test detects RNA from the SARS-CoV-2 virus by relying on CRISPR to amplify the signal. The test involves mixing the assay solution with a sample of patient saliva on a special chip, which then heats and amplifies a specific region of the virus’s RNA. According to a Tulane announcement, “A modified CRISPR complex that contains a ‘guide’ RNA specific for this virus RNA region rapidly binds and cuts both this amplified RNA region and a tagged DNA probe to produce a fluorescent signal that is read by the smartphone device.” “This test addresses the critical needs for a rapid, ultrasensitive COVID-19 diagnosis along with effective large-scale screening efforts,” added Tony Hu, PhD, corresponding author of the study, in a press release. “Our development can quickly identify patients who have the virus, which is required to help address the ongoing threat to public health worldwide. The sensitivity and simplicity of this test, its straightforward sample collection procedure, and the inexpensive nature of the readout device should permit the rapid translation of this approach to COVID-19 testing efforts once we obtain FDA approval.” Study in Science Advances: A smartphone-read ultrasensitive and quantitative saliva test for COVID-19 More from Tulane University…
A team of researchers, including those at the University of California, San Francisco and University of California, San Diego, has tested the potential of a smart ring, that can collect health data, including temperature and heart rate, to detect fever associated with COVID-19. In a proof-of-concept study, the researchers showed that the ring, developed by a Finnish startup called Oura, could detect fevers before patients began to experience symptoms, suggesting that the technology could function as an early warning system for COVID-19. Identifying COVID-19 infections early and implementing quarantine immediately could help to limit the spread of the virus and allow patients to receive care early. One of the most common symptoms in COVID-19 infections is a fever, and it is common that the early stages of a fever are be subtle and go unnoticed. Using a wearable to track body temperature is one way to catch an early sign of infection. The Oura ring can measure a variety of health parameters, including heart rate, activity levels, temperature, and respiratory rate. “This isn’t just a science problem, it’s a social problem,” said Benjamin Smarr, a researcher involved in the study, in a press release. “With wearable devices that can measure temperature, we can begin to envision a public COVID early alert system.” In this study involving 50 volunteers who owned Oura rings, the onset of fever was easily identified in the data collected by the rings. “The chart tracking people who had a fever looked like it was on fire,” said Smarr. Interestingly, the researchers observed that the onset of fever occurred before people began noticing COVID symptoms, suggesting that the technology could function as an early warning system. In some cases, people didn’t notice any other symptoms apart from the fever. “It supports the hypothesis that some fever-like events may go unreported or unnoticed without being truly asymptomatic,” said Smarr. “Wearables therefore may contribute to identifying rates of asymptomatic [illness] as opposed to unreported illness, [which is] of special importance in the COVID-19 pandemic.” Study in Scientific Reports: Feasibility of continuous fever monitoring using wearable devices Product page: Oura Ring… Via: University of California San Diego
BIOTRONIK won FDA clearance for the Vital Data Sensor, a body temperature component within the BIOMONITOR IIIm injectable cardiac monitor (ICM). The ICM is designed to help cardiologists detect and diagnose cardiac arrhythmias remotely, but thanks to the Vital Data Sensor the implant now has an additional role in monitoring for signs of fever. This is particularly important right now as the COVID-19 pandemic lingers on, but will remain a useful patient monitoring tool even when the current virus recedes. “The patient is at high risk for infection during this global pandemic due to underlying conditions,” said Dr. Di Biase, section head of Electrophysiology, Director of Arrhythmia Services at Montefiore Health System, in a BIOTRONIK press release. “It is comforting for me and my patients knowing that we will be able to monitor for early signs of potential life-threatening cardiac arrhythmias and infections for up to 5.5 years. Coupled with the workflow advantages, this device is a step forward for injectable cardiac monitors.” Given that patients with existing cardiac conditions are at a greater risk for poor COVID-19 outcomes, closely monitoring them for the earliest signs of infection should help improve outcomes. Moreover, the technology can help keep such patients away from hospitals when there’s no need for them to come in, avoiding unnecessary in-person contacts and keeping the healthcare system focused on those with the greatest needs. “Vital data trends help support the diagnosis for a range of illnesses and, given the additional impact of the current pandemic on cardiac health, we have worked with urgency to advance BIOMONITOR IIIm’s unique sensor technology,” added Dr. David Hayes, Chief Medical Officer of BIOTRONIK Inc. “Patients with cardiac conditions are at an increased risk for worse outcomes from many systemic illnesses, so closer monitoring of these patients may help manage potential symptoms associated with a febrile response, particularly if it can be done safely and remotely.” Here’s a quick animation showing how the device is implanted: Product page: BIOMONITOR IIIm Flashbacks: BIOTRONIK Releases BIOMONITOR III Injectable Cardiac Monitor; BIOMONITOR III Injectable Cardiac Monitor Wins FDA Clearance; BIOTRONIK BioMonitor 2 Wireless Implantable ECG Recorder FDA Approved; BIOTRONIK BioMonitor Implant Keeps a Close Eye on Heart Rhythms; BIOTRONIK Releases BioMonitor 2 Wireless Subcutaneous ECG System; BIOTRONIK’s BioMonitor 2 Implantable Wireless ECG Recorder Approved in Europe Via: BIOTRONIK
Singapore’s Breathonix has said a clinical trial of its COVID-19 breathalyzer test was able to achieve at least 90% accuracy after screening participants on-site for 60 seconds.
In this interview, Ghaith Hamza from AstraZeneca talks to News-Medical Life Sciences about the basic principles of Affinity-Bead Assisted Mass Spectrometry (Affi-BAMS) and how Affi-BAMS can help target specific proteins for proteomic applications.