Vol.41  「A new era of digital health: detects Covid-19 from the cough sounds」

Last Updated 13 May 2022. Cellspect Co., Ltd.

On April 12th, Pfizer, through its subsidiary, acquired Australian digital health company ResApp Health for US$74.3 million. The company focuses on developing mobile applications for diagnosing respiratory diseases, using machine learning algorithms to detect the presence of COVID-19 from the cough sounds.

 

ResApp Health is currently conducting three clinical trials, and recently announced their promising clinical trial data of its COVID-19 Test App. The clinical trial enrolled 741 subjects in India and the United States, including 446 patients with COVID-19. As long as the user coughs to the microphone five times, the App can perform machine learning analysis on the coughing sounds to screen whether the user has COVID-19. The clinical data have shown sensitivity (true positive rate) of 92% and specificity (true negative rate) of 99%.

 

The instant screening test of ResApp uses cough sounds to indicate the presence of infection, similar to the use of a doctor's stethoscope. However, ResApp picks up 'significantly more information than the sounds picked up by a stethoscope as well as removing the need for human interpretation.' By using a large dataset of clinically-labelled non-COVID-19 cough samples, including coughs from patients with non-COVID-19 lower respiratory tract infections, ResApp will be able to ensure that any COVID-19 screening test developed accurately identifies COVID-19 and not other respiratory diseases.

 

One thing to note is that the accuracy of the test decreases if the patient is asymptomatic. According to the CEO of Resapp, if the patient is really asymptomatic, the accuracy rate drops to 50-60 percent.

 

The App can also improve the security of the test and the accuracy of the test report through biometric identification (such as face recognition and fingerprint recognition). In the future, it will be applied to fields that require frequent COVID testing, such as tourism, entertainment venues, medical staff, student screening, and the elderly care market.

 

The mobile apps developed by ResApp Health also include ResAppDx and SleepCheck. ResAppDx is a smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings and SleepCheck is a smartphone application which allows consumers to self-assess their risk of sleep apnoea, both products are CE Marked in Europe and TGA approved in Australia.

 

Because of COVID-19 pandemic, the digital health nowadays is thriving, ushering in a whole new era. Various App detections are not only fast and accurate, but also greatly reduce human errors. It not only saves manpower, but also overcomes the barriers of distance, reaching milestones that traditional medicine can hardly believe. And this is just the beginning, the future of digital health is still limitless and exciting.

 References:​​

  1. April 12, 2022 “Pfizer Australia proposes acquisition of ResApp Health”. Medical Device Network

  2. Rachel Arthur, April 14, 2022. “Pfizer set to acquire COVID-19 smartphone detection app for $100m”. BioPharma-reporter.

  3. Louisa Rebgetz, April 12, 2022. “Pfizer offers $100m to buy Brisbane company behind smartphone app that diagnoses COVID-19” ABC NET News

 

Vol.42  「Are COVID surges becoming predictable? Latest Omicron subvariants offer a hint」

Last Updated 27 May 2022. Cellspect Co., Ltd.

Due to the differences in mutations, several subvariants of Omicron have been discovered recently in the world. According to the monitoring of the U.S. CDC, the proportion of the subvariant "BA.212.1" of SARS-CoV-2 (COVID-19) Omicron subvariant BA.2 is rising to 36.5% by the end of April in the U.S. South Africa also reported new Omicron subvariants BA.4 and BA.5, which accounted for nearly 60% by the end of April. All three subvariants appear to have spread faster than the current global epidemic of BA.2, causing a new wave of increases in cases and hospitalizations in the United States and South Africa.

 

Outside South Africa, BA.4 and BA.5 have also been found in over 15 countries. Studies have shown that BA.4 and BA.5 may evade antibodies caused by the original Omicron virus, BA.1, and the researchers believe that BA.4 and BA.5 "may lead to new waves of infection." It is worth noting that BA.212.1, BA.4 and BA.5 all have the L452Q mutation, which is the key mutation site of the previous Delta, but the absence of this mutation in the original Omicron may give the virus more advantages in transmission and immune escape.

While there are still concerns over whether the unknown subvariants of the virus could render the vaccine ineffective and increase the number of infections, some scientists have recently suggested that the rise of these Omicron subvariants may mean that SARS-CoV-2 waves are beginning to settle into predictable patterns, with new waves periodically emerging from circulating strains. 

 

“These are the first signs that the virus is evolving differently,” compared with the first two years of the pandemic when variants seemed to appear out of nowhere, says Tulio de Oliveira, a bioinformatician at Stellenbosch University in South Africa. Previous variants, including Alpha, Delta and Omicron, differed substantially from their immediate predecessors, and all emerged, instead, from distant branches on the SARS-CoV-2 family tree.

Virologist David Ho at Columbia University in New York City said that the emergence of these strains suggests that the Omicron lineage is continuing to make gains by eroding immunity. “It’s pretty clear that there are a few holes in Omicron that are gradually being filled up by these new subvariants”, said Ho. If SARS-CoV-2 continues along this path, its evolution could come to resemble that of other respiratory infections, such as influenza. In this scenario, immune-evading mutations in circulating variants, such as Omicron, could combine with dips in population-wide immunity to become the key drivers of periodic waves of infection. It is probably what we should expect to see more and more of in the future.

In fact, in addition to SARS-CoV-2, there are four other coronaviruses that are already circulating in the population. According to research in Europe and the United States, about 1 in 10 people who have flu symptoms during the flu season each year actually get the coronavirus, not the flu virus, so the coronavirus has long been in our lives. As for when the COVID-19 virus will become the fifth "normal" virus to persist in the human population for a long time, it may ultimately depend on our means. It is believed that when the virus becomes predictable and controllable, humans can coexist peacefully with the virus.

 References:​​

  1. Carolyn Crist, May 4, 2022, “Latest COVID Subvariants Create New Waves, Evade Immunity”. Medical Device Network

  2. Ewen Callaway, May 6, 2022, “Are COVID surges becoming more predictable? New Omicron variants offer a hint”. Nature.

  3. Houriiyah Tegally et al., May 2, 2022. “Continued Emergence and Evolution of Omicron in South Africa: New BA.4 and BA.5 lineages” medRxiv

  4. Xiaoliang Xie et al., May 2, 2022. “BA.2.12.1, BA.4 and BA.5 escape antibodies elicited by Omicron BA.1 infection” bioRxiv

 

Vol.43  「FDA Approves Labcorp’s non-prescription COVID-Flu-RSV Home Test」

Last Updated 10 June 2022. Cellspect Co., Ltd.

On the 16th, U.S. time, the U.S. Food and Drug Administration (FDA) granted Labcorp an Emergency Use Authorization (EUA) for its respiratory virus detection kit, which is the first non-prescription (OTC) that can simultaneously detect SARS-CoV-2, influenza and Respiratory syncytial virus (RSV).

 

“While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a health care professional,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH). “The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home.”

 

This home sample collection kit can be purchased online or in a store without a prescription. The samples can be self-collected by individuals ages 18 years and older, self-collected by individuals 14 years and older with adult supervision, or collected with adult assistance for individuals 2 years and older. This will enable consumers to more easily determine whether they may be infected with COVID-19, flu, or RSV, which can aid in determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional. According to the company, the new test detects known COVID-19 variants, including Delta and Omicron.

 

On the same day, LabCorp also released the "Labcorp OnDemand" home testing kit, which can measure HbA1c in small blood samples. HbA1c reflects the average blood glucose concentration in the human body for 8-12 weeks, and is the main indicator for monitoring and screening diabetic patients or pre-diabetic patients. This test kit makes diabetes screening and management easier.

 

LabCorp has been making breakthroughs in home testing. It's COVID-19 home test was the first FDA-approved non-prescription COVID-19 test. With the increasing awareness of the prevention of infectious diseases, the mode of disease prevention has gradually changed. Demand for home testing kits is expected to increase greatly. It is believed that these practical and convenient home testing kits will enable better development of disease prevention in the future.

 References:​​

  1. May 16, 2022, “Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV”. FDA News Release

  2. Kathleen Doheny, May 18, 2022, “FDA Approves First COVID-Flu-RSV Home Test”. WebMD.

  3. May 16, 2022. “Labcorp Launches First-of-its-kind At-home Collection Device for Diabetes Risk Testing” businesswire

 

Vol.44  「Worry about the effectiveness of vaccines against variants? Vaccine effectiveness can be tested by a drop of blood 」

Last Updated 24 June 2022. Cellspect Co., Ltd.

whether the protection of the vaccine is sufficient? Are various types of vaccines providing protection? How many booster shots shall we take?


In this regard, a research team from Taiwan recently developed a "high-throughput SARS-CoV-2 variant virus protein chip", which can measure the antibody responses and surrogate neutralizing activities against multiple SARS-CoV-2 variants with just a drop of blood. The protein chip is used to analyze the immune response of patients with mild and severe Covid-19. By detecting and analyzing the immune characteristics of patients, it can assist in diagnosis and preventive medicine administration. Moreover, it can even suggest if a booster shot is needed. These two research results were recently published in the journals "Biosensors and Bioelectronics" and "Analytical Chemistry".

 

The leader of the research team pointed out that because the current vaccine is designed for the original virus strain, the effect against the variants is not clear, and people's responses to the vaccine also vary, prompting the team to develop a test for multiple virus variants.

 

The fingertip-sized assay chip uses different spike proteins from SARS-CoV-2 variants to construct a protein microarray. It takes only about one hour to analyze the "neutralization efficacy" and "antibody concentration" against the SARS-CoV-2 in the blood. This detection technology can simulate the combination of various viruses and receptors on the chip, which has the advantages of saving samples, saving time, saving money and analyzing multiple variants at the same time. The simplified experimental process can also ensure the safety of operators. The test can also compare the effectiveness of different COVID-19 vaccines, such as adenovirus vaccines and mRNA vaccines. For example, in their study, they found that vaccination with AstraZeneca increased serum IgG and IgA, while vaccination with mRNA vaccines increased serum IgG and IgM.

 

From a clinical standpoint, the ability to perform multiple tests simultaneously with a small amount of blood seems like a dream come true. This protein chip detection technology can bring more convenience to small clinics, telemedicine or home care. At the same time, with the rise of personalized medicine, consumers' curiosity and demand for their own health data have greatly increased, and being able to detect their own antibody protection will be more helpful for the judgment of future vaccinations. It is believed that this technology can also be used in more applications in the future to benefit more people.

 References:​​

  1. Tzong-ShiannHo et al., May 15, 2022, “Development of SARS-CoV-2 variant protein microarray for profiling humoral immunity in vaccinated subjects”. Biosensors and Bioelectronics.

  2. Wen-Yu Su et al., April 20, 2022, “Antibody Profiling in COVID-19 Patients with Different Severities by Using Spike Variant Protein Microarrays”. Analytical Chemistry.

 

Vol.45  「FDA Advisory Committees Recommend COVID-19 Vaccine Shots for Kids under 5 」

Last Updated 8 July 2022. Cellspect Co., Ltd.

On June 15, the U.S. Food and Drug Administration (FDA) Advisory Committees voted unanimously 21-0 to recommend emergency use authorization (EUA) of Pfizer-BioNTech and Modena vaccines to be administered to children over 6 months old. The FDA, which typically follows the recommendations of its advisory committees, may approve the EUA within this week if all regulatory steps are cleared, and the White House has indicated that a vaccination campaign for kids under 5 could begin as soon as June 21.

 

One of the biggest differences between the two vaccines is the number of shots:
• Moderna: two shots, 25μg/shot, for children 6 months to 5 years old
• Pfizer-BioNTech: three shots, 3μg/shot, for children 6 months to 4 years old

 

Although dosages vary between companies, both will give to the youngest children at lower doses than adults and older children to best balance protection benefits against the potential risk of side effects. Side effects can occur after an injection, ranging from mild ones such as fever and swelling at the injection site to more serious, but rarer ones, such as inflammation of the heart tissue and multisystem inflammatory syndrome (MIS-C), which causes inflammation in many parts of the body.

 

It is worth mentioning that Pfizer-BioNTech finally decided to give three doses after clinical results showed that vaccination of two shots did not elicit a strong enough immune response. At the FDA meeting, Pfizer officials said their main goal was to avoid side effects such as fever, which could prevent parents from getting their kids vaccinated. Eventually, they decided to lower the dose and increase the number of shots to three.

 

FDA advisors say both vaccines appear to be safe and effective in children as young as 6 months old. Side effects, including fever and fatigue, are usually mild in both cases and less common than in adults. Regarding the risk of myocarditis, both vaccines are relatively safe and do not produce more adverse effects in children than in adults.

 

We now know that vaccines do not completely prevent coronavirus infection, especially when the highly contagious Omicron variant is prevalent. They are, however, still safe and effective in containing COVID-19. For many parents anxious to protect their children, children under five are currently the last age group to be vaccinated against COVID-19, and now, the long-wait is almost over. After the EUA of vaccine is issued to this age group, this will add the final piece of the puzzle, allowing people of all ages to vaccinate against the novel coronavirus. The benefits of vaccination are not only preventing disease, but also reduce children's chances of developing complications such as long COVID, and offer some freedom to families who are largely isolated until the youngest member is vaccinated.

 References:​​

  1. Video: “Vaccines and Related Biological Products Advisory Committee – 6/15/2022” U.S. Food and Drug Administration (FDA)

  2. “Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement” U.S. Food and Drug Administration (FDA)

  3. June 15, 2022, “FDA advisers move a step closer on COVID-19 vaccines for kids under 5”. CBS NEWS.

  4.  Alice Park and Jamie Ducharme, June 15, 2022, “FDA Panel Recommends Moderna and Pfizer COVID-19 Vaccines for Children 6 Months and Older”. TIME.

Vol.46  「Over 1,000 genes associated with severe COVID-19, many linked to NK cell dysregulation」

 

Last Updated 22 July 2022. Cellspect Co., Ltd.

During the last two years of the pandemic, scientists have clearly found that Covid-19 affects people differently. Age and chronic illness greatly increased the risk of severe Covid-19 and death at the start of the pandemic. So, senior citizens were all told to quarantine. Over time, however, other patterns emerged in the pandemic. People found that not every patient with chronic diseases or elderly person will develop severe Covid-19, even in the face of the deadly Delta variant. Meanwhile, some healthy young people developed severe Covid-19 and even died within days.
   

Recently, a joint research team from the University of Sheffield in the United Kingdom and Stanford University in the United States announced that through machine learning, they have found more than 1,000 genes related to severe COVID-19, which may account for 75% of the genetic drivers of severe disease. In addition, some of them are related to the dysregulation of natural killer cells (NK cells), which may be one of the reasons why some people are particularly vulnerable to severe disease after infection with the novel coronavirus. The study was published in Cell Systems.
   

The research team believes that in addition to the infected person's age, body mass index (BMI) and pre-existing health conditions, genetics can also affect the severity of symptoms after infection. In order to unravel the genetic structure behind the severity of symptoms of new coronavirus infection, the research team used several large databases for analysis. For example, using the genetic information of lung tissue from healthy people, the gene expression of 19 types of cells in the lungs was locked; using the largest genetic database of patients with severe Covid-19 "COVID-19 Host Genetics Initiative" to find out whether certain gene mutations are particularly high or low in critically ill patients.
   

Moreover, the research team also used machine learning to compare the found mutation information with the genomes of different types of lung cells to find out which genes in which cells of critically ill patients lost their normal functions. In the end, it was found that a large part of the severe new crown is related to the weakening of natural killer cells (NK cells) and T cell responses, especially the subtype of NK cells called CD56 bright is the most important.

 

The research team said that NK cells are like "generals" at the frontline of the fight against infection. In addition to destroying viruses, they also help to produce cytokines (Cytokine), which tell immune cells where to go and what to do, which is called interference. Cytokines of interferon gamma (interferon gamma) are key activators of immune cells. However, they found that important genes were expressed less in NK cells in critically ill patients, making the immune response less robust and NK cells not doing their job.
 

The research team believes that this research will serve as the basis for genetic testing to predict who is born with a high risk of severe illness and assist in taking the necessary preventive measures. Currently, there are already some drugs which can kickstart sluggish NK cells to treat some types of cancer. These drugs bind to receptors on the NK cells and trigger them to have a more robust response. Trials of NK cell infusions for severe Covid-19 are also under way. It is believed that these new trials and discoveries will be of great help for the treatment of severe COVID-19 patients in the future.

 References:​​

  1. Sai Zhang et al., Jun 3, 2022 “Multiomic analysis reveals cell-type-specific molecular determinants of COVID-19 severity” Cell Syst. PMID: 35690068 

  2. Jun 14, 2022 “New research identifies more than 1,000 genes linked to severe COVID-19” The University of Sheffield, News release

  3. Jun 14, 2022, “Researchers identify more than 1,000 genes linked to severe COVID-19”. Stanford Medicine, News.

 

Vol.47  「New Study Shows COVID-19 Re-infection Increases Risk of Mortality, Cardiovascular and Pulmonary Damage」

Last Updated 12 August 2022. Cellspect Co., Ltd.

The Covid-19 variant, Omicron has blown through the large population with stunning speed from last winter, and since then the subvariants also have arrived in rapid succession, starting with BA.1 and BA.2 in the spring, and now BA.4 and BA.5. The researchers noted that the latest Omicron subvariant, BA.4 and BA.5, are more capable of evading innate immune responses than the previous BA.1, BA.2. Even after recent infection with BA.1 or BA. 2, the chance of re-infection with BA4 or BA.5 is also high. The coronavirus subvariant BA.5 accounts for nearly 54% of the U.S.’s Covid-19 cases while BA.4 makes up 17%, according to a recent CDC report. Therefore, scientists are starting to notice the possible effects of re-infections with Covid-19.

 

Recently, a joint study by Washington University School of Medicine and the St. Louis Health Care System Veterans Hospital found that each re-infection of COVID-19 will increase the risk of mortality, cardiovascular and pulmonary damage. The study was published on the preprint platform "Research square" and is under review by relevant journals of "Nature".

 

This study used the electronic health records of more than 5.6 million people in the Veterans Health Administration's health care system to analyze the people who have been infected with Covid-19 twice or more. Among those with reinfections, 36,417 people had two Covid-19 infections, 2,263 had caught Covid-19 three times, and 246 had been infected four times. The average interval between 1st and 2nd infection was 79 days, and the interval between 2nd and 3rd was 65 days.

 

The researchers found that people who had two or more infections more than doubled their risk of dying within six months of their last infection and had a three-fold increased risk of being hospitalized. And those who have had 2 or more infections suffer from lung and heart problems (including cardiovascular disease, blood clotting and blood disorders), fatigue, gastrointestinal and kidney disease, diabetes, musculoskeletal disease, mental health disorders and neurological There is also a higher risk of systemic problems.

 

Generally, if a person had an infectious disease before, his immune system is trained to recognize the disease and is more equipped to fight it. If you're getting the disease again, maybe it doesn't affect you that much, but unfortunately, that's not really true in the case of Covid-19. In the case of Covid-19, the first infection may also weaken certain organ systems, making people more vulnerable to health risks when they are infected a second or third time. It is supported by clear research evidence that that sicker individuals or people with immune dysfunction are at higher risk of reinfection and adverse health outcomes after reinfection. Therefore, even with the various restrictions on Covid-19 that many countries have opened up, everyone should remain vigilant to avoid re-infection.

 References:​​

  1. Ziyad Al-Aly, Benjamin Bowe, Yan Xie, Jun 17, 2022 “Outcomes of SARS-CoV-2 Reinfection” Research Square. PMID: 35690068

  2. Joel Achenbach, Jul 10, 2022 “As the BA.5 variant spreads, the risk of coronavirus reinfection grows” The Washington Post

  3. Brenda Goodman, Jul 5, 2022, “Covid-19 reinfections may increase the likelihood of new health problems”. CNN

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