Scientists, including one of Indian-origin, have developed a prototype of a rapid COVID-19 test using a simple-to-use portable instrument for reading the results with a smartphone in 30 minutes, an innovation that may enable point-of-care diagnosis without needing to send samples to a lab.

According to the study, published in the journal PNAS, the new technology may help overcome bottlenecks in supplies and laboratory personnel which have led to long waiting times for COVID-19 test results in several parts of the world amidst the ongoing pandemic.

“If such a device and test were available, we could test for COVID-19 at public events, auditoriums, large gatherings and potentially even at home for self-testing. The results could be sent back to the appropriate public health system for coordination,” said Rashid Bashir, a professor of bioengineering at the University of Illinois, Urbana-Champaign in the US.

In one of the common methods to test for the novel coronavirus SARS-CoV-2, healthcare workers take a sample from patients with a long nasopharyngeal swab, which is put into a substance called viral transport media, and send to a lab for extracting, isolating, and multiplying the viral genetic material, the scientists said.

This viral RNA multiplication process, called RT-PCR, requires several temperature fluctuation cycles, specialised equipment, and trained personnel, said Brain Cunningham, another co-author of the study.

In the current research, the scientists used a simpler process to analyse the viral transport media, called LAMP, which bypasses the RNA extraction and purification steps.

“LAMP only needs one temperature — 65 C — so it is much easier to control,” said Anurup Ganguli, the first author of the study.

“Also, LAMP works more robustly than PCR, especially when there are contaminants in the test sample. We can just briefly heat the sample, break open the virus, and detect the genetic sequence that specifically identifies SARS-CoV-2,” Ganguli said.

When the researchers compared the LAMP assay with PCR, they found the results were in agreement, following which they documented the sensitivity and specificity of the LAMP test.

The scientists then incorporated the assay onto a small 3D-printed cartridge that has two input slots for syringes — one for the sample-containing viral transport media, one for the LAMP chemicals.

Once the two syringe components are injected, they the react within the cartridge, the study noted.

“We use modern, high speed additive manufacturing to make these cartridges. The entire thing can be quickly scaled up to hundreds of thousands of tests,” said Bill King, another co-author of the study from the University of Illinois.

“Production scale-up is typically the biggest obstacle for commercial applications of microfluidic cartridges, and we can overcome that obstacle using this new approach. Modern additive manufacturing is elastic and scalable, and it can be ramped up very quickly compared with legacy manufacturing technologies,” King said.

According to the researchers, the cartridge can be inserted into a hand-held portable instrument with a heating chamber, which heats the cartridge to 65 degrees Celsius for the duration of the reaction, and a smartphone cradle is in place for reading the results.

In approximately 30 minutes, a positive result will emit fluorescent light, they said.

“The reader illuminates the liquid compartments with light from blue LEDs, while the phone’s rear-facing camera records a movie of the green fluorescent light being generated,” Cunningham explained.

The scientists noted that they are currently assessing whether the assay would work with saliva samples to eliminate the need for nasopharyngeal swabs.

Fujitsu and Tokyo Shinagawa Hospital have announced the launch of a joint R&D project for AI technology to support diagnostic imaging via chest CT (Computed Tomography), which represents a promising candidate for the effective diagnosis of COVID-19 pneumonia.

The newly-proposed technology supports doctors performing diagnostic imaging on patients suspected of having COVID-19 pneumonia, presenting the likelihood of infection through a numerical, three-dimensional visualization of the spread of shadows in the lungs using chest CT imaging. Applying AI to this analysis could significantly reduce the burden on doctors who diagnose COVID-19 pneumonia by automating a process that normally demands the visual confirmation of hundreds of chest CT images per patient. Fujitsu and Tokyo Shinagawa Hospital anticipate that the system will deliver early detection of cases of COVID-19 pneumonia based on chest CT image findings, even in cases in which the possibility of infection is determined to be low upon initial examination.

This joint research will enhance AI diagnostic support technology for novel coronavirus pneumonia, and Fujitsu ultimately aims to commercialize the technology as a healthcare solution for frontline medical professionals

When treating patients who are strongly suspected of having a novel coronavirus infection, the diagnosis and treatment plan are determined holistically based on PCR test results as well as other test results including blood tests and chest CT test (Figure 1). Even if the PCR test is negative, the diagnosis of new-onset coronavirus pneumonia can be made by other tests, and imaging with chest CT is an important consideration.

Doctors make lung disease diagnoses based on the characteristics of the shadows in the lesion on the patient’s chest CT image. In addition to identifying abnormalities, they visually check hundreds of chest CT images per patient to understand the three-dimensional distribution of shadows throughout the lung. A growing demand for technologies that reduce the burden on doctors and support speedy decision-making has accompanied the spread of the COVID-19 virus. It is also important to identify novel coronavirus pneumonia from a CT scan of the patient’s chest if there is a low likelihood of a novel coronavirus infection during the examination and PCR testing is not performed. In response to the need for diagnostic support, Fujitsu and Tokyo Shinagawa Hospital will jointly embark on the development of AI-assisted diagnostic imaging technology for chest CT scans, which are considered to be an effective method in diagnosing novel coronavirus pneumonia.

About the joint development of AI imaging support technology

Past CT image data of COVID-19 pneumonia patients from Tokyo Shinagawa Hospital will aid in the development of AI technology that detects abnormal shadow patterns in the lungs. As the AI learns from this data about the possibility of COVID-19 pneumonia, Fujitsu and Tokyo Shinagawa Hospital will work together to evaluate the effectiveness of the technology.

When diagnosing COVID-19 pneumonia, patterns of abnormal opacities in the lungs as well as the spread of shadows across the entire lung is important information. Patterns of abnormal shadows are detected using AI developed by Fujitsu Laboratories, Ltd. The lung is divided into four areas on the CT image: the right lung periphery, the right lung center, the left lung center, and the left lung periphery. The distribution of shadows in the vertical direction in each area is displayed in a histogram(1). This will enable the development of new AI that can quantify the three-dimensional spread of shadows, while using the detected abnormal shadow patterns and shadow distributions to identify COVID-19 pneumonia.

While showing the possibility of COVID-19 infection with the AI technology, the aim is to shorten the amount of time doctors spend visually confirming the three-dimensional spread of the shadow from hundreds of chest CT images and to allow even non-specialists to efficiently diagnose COVID-19 pneumonia.

Future Plans

Through this joint research and development, Fujitsu and Tokyo Shinagawa Hospital aim to deliver technology that leverages a variety of information for diagnosis of COVID-19 pneumonia to achieve improved diagnostic support from chest CT image diagnosis.

Fujitsu is considering the commercialization of this technology as a healthcare solution. By linking it with electronic medical record information, the goal is to support diagnosis by doctors based on chest CT images, while also expanding the application area of this technology.

Indian Tech Startup Muse Wearables has launched an Artificial Intelligence-powered Personal Wellness Smart Band equipped with a skin temperature sensor and ‘context-aware’ activity tracking. Called ‘Muse Cue,’ this made-in-India device can detect silent hypoxia at an early stage and has an Intelligent ‘cough analysis’ tool to predict and alert users in advance of the onset of COVID-19 symptoms.

Launched on Friday in a virtual event, Muse Cue is the ideal smart wearable to manage personal fitness and monitor vitals including SPo2 (oxygen saturation) and heart rate. Its AI-infused technology can accurately measure and raise alerts. The Muse Care Platform will enable digital consultations with doctors.

With Muse Cue, the IIT Madras-incubated Startup Muse Wearables has taken personal wellness assistance to a new level. Muse Health app enables a user to be proactive in case of any vitals going off baseline values and with one click, it can connect the user to a specialist. Unlike existing tele-consulting, the healthcare professional assigned to the user by Muse Care will have real-time access to the body vitals and can provide necessary medical guidance accordingly.

“Muse Cue Smart Band can detect in advance of one to three days before the onset of COVID-19 symptoms, like high body temperature or low Oxygen levels, and notifies the user. Based on the vitals of the user, the Muse App triggers the alert to take a ‘cough analysis’ and within 30 seconds, it predicts the health risk. Continuous tracking also helps monitor the progression of COVID-19 from the pre-symptom stage, through symptom stage until the recovery stage,” he added.

Muse Wearables sells the world’s first payment-enabled hybrid smartwatches across 70 countries with its wearable payments service live in 29 countries. Muse Wearables Startup was founded by KLN Sai Prasanth and Yathindra Ajay KA, graduates of IIT Madras, and K Prathyusha, an NIT Warangal Graduate.

The Launch Price of the product is Rs 3,599 (till September 20, 2020) after which the regular price would be Rs 4,999. It can be ordered using the link – https://in.musewearables.com/pages/muse-cue. Pre-orders will be accepted until September 20, 2020, after which the deliveries will commence, Muse Wearables said.

Muse Cue has a battery life of seven days with intelligent monitoring and up to 45 days, without intelligent monitoring. It has many more features such as temperature alerts, hypoxia alerts, Call alerts, sleep alarm, hypoxia alerts, health cues, social distancing and contact tracing, among others.

Muse Cue has two main key functionalities. Continuous monitoring of the body vitals whether the user is awake or asleep, and then it concludes on the Baseline values of their body. The AI system in Muse Tracker learns from these baseline values to gain an understanding of the body patterns and provides concrete alerts during discrepancies.

Trackers usually measure vitals based on various electrical impulses, requiring the users to stay still for highly accurate measurements, which help reduce the noise in the signals captured. The Muse tracker is context-aware and can judge the best moment to start measuring body vitals. The motion compensator will factor in the slightest of movements that might normally affect readings. Once the measurements are taken, Muse Cue sends all of the data onto the Muse Health App.

Muse Wearables is based out of Bengaluru with registered offices in Chennai, Singapore and London. It currently caters to nearly 70 countries through ‘Direct to Consumer’ Business Model (selling products through online platforms directly to the consumer).

In the next five years, Muse Wearables aims to be a leading innovative technology company in India and build a global consumer brand with cutting-edge innovations across consumer electronics, consumer health tech, digital id and cashless payments.

FUJIFILM Sonosite, Inc., specialists in developing cutting-edge point-of-care ultrasound (POCUS) solutions, and part of the larger Fujifilm Healthcare portfolio, announced that the company has received 510(k) Clearance from the U.S. FDA for the company’s entire POCUS portfolio to support healthcare providers in performing accurate lung and cardiac imaging in COVID-19 patients.

Fujifilm Sonosite creates point-of-care ultrasound systems and medical informatics solutions along with transducers and accessories that can help physicians improve time-to-diagnosis, patient outcomes, procedural efficiency, and workflow.

“POCUS has emerged as a critical tool to support clinicians in their tireless efforts to evaluate lung and cardiac complications of COVID-19,” said Diku Mandavia, MD, FACEP, FRCPC, Senior Vice President and Chief Medical Officer of FUJIFILM Sonosite, Inc. “We’re very pleased that Fujifilm Sonosite’s POCUS portfolio has received this clearance from the FDA and most importantly, that our technology is contributing to helping physicians care for patients during one of the world’s worst pandemics in history.”

Coinciding with the company’s newly cleared 510(k), Fujifilm Sonosite announced the release of a comprehensive user guide designed to assist healthcare professionals on how to best utilize POCUS technology to correctly interpret ultrasound images to recognize the most typical COVID-19 findings relating to lung and cardiac conditions.

“COVID-19 patients can deteriorate rapidly in a matter of minutes to hours, and ultrasound is there and ready when we don’t have minutes to spare. And while ultrasound alone doesn’t tell me exactly what the disease is, it allows me to look for typical COVID-19 ultrasound findings as well as assess the disease severity to determine the optimal management plan for the patient,” says Dr. Vi Dinh MD, FACEP, RDMS, RDCS, emergency medicine and critical care physician at Loma Linda University Medical Center, in Loma Linda, California. “I appreciate that point-of-care ultrasound is much safer, faster to use, and easier to sanitize than many other medical devices in the emergency department and intensive care unit. This technology is truly critical in the fight against COVID-19.”

“Fujifilm Sonosite has long demonstrated its commitment to educating clinicians such as emergency physicians and ICU physicians who typically use POCUS to do bedside imaging,” said Rich Fabian, President and Chief Operating Officer of FUJIFILM Sonosite, Inc. “However, this pandemic calls for support from all medical professionals. So many diverse specialists are being asked to get in the trenches and help save lives in the COVID-19 battle. So now, with such widespread use of POCUS by so many types of clinicians, education is more important than ever and Sonosite is here to help.”

About Fujifilm Sonosite
FUJIFILM Sonosite, Inc. is the innovator in bedside and point-of-care ultrasound, and an industry leader in ultra high-frequency micro-ultrasound technology. Headquartered near Seattle, the company is represented by a global distribution network in over 100 countries. Sonosite’s portable, compact systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high-performance ultrasound to the point of patient care.

FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship.