Wednesday, November 25, 2020

Inexpensive and Rapid Tests can Distinguish Between Chagas Disease Parasites

A new rapid diagnostic test that can differentiate between different strains of Chagas disease parasite could lead to a widespread testing program.

Researchers from Imperial College London, the University of Kent, the London School of Hygiene and Tropical Medicine, and the charity TroZonX17 have developed a blood test that can identify the main types of parasite that cause Chagas disease, which affects eight million people primarily in Latin America.

This rapid diagnostic test (RDT) could be performed cheaply and quickly using a small sample of blood. The details of the test are published in Scientific Reports.

Chagas disease affects some of the poorest areas of Latin America and is increasingly becoming a global health threat. The disease is transmitted via a 'kissing bug' that carries the parasite Trypanosoma cruzi. Left untreated, the parasitic infection can permanently damage the heart, nervous system or intestines and lead to lifelong disability and death.

However, the initial symptoms are usually mild, which makes early detection difficult without a diagnostic test; the World Health Organization estimates that as few as one percent of cases are detected. Existing tests are expensive, and no point-of-care rapid tests can differentiate between the six principal groups of the parasite, which tend to vary by geographical region.

Changing the picture

Co-author Professor Stuart Haslam, from the Department of Life Sciences at Imperial, said, "Chagas is a devastating disease that is historically difficult to tackle. Our new test could dramatically change that picture, helping control a disease that currently runs unchecked through millions of people."

Similar to the various color-coatings found on Smarties and M&Ms, slightly different sugars (or glycoproteins) decorate the surface of the various strains of the T. cruzi parasite. During infection, the T. cruzi glycoproteins contribute to alerting the human immune system. The immune system then labels the glycoprotein as a threat and raises antibodies that target it. The new test design allows detection of antibodies that recognize the different glycoproteins.

Study co-author and TroZonX17 CEO, Barrie Rooney, said: "We made a synthetic, glycosylated antigen that mimicked a T. cruzi strain-specific glycoprotein and, in collaboration with research scientists in Latin America, we tested the antigens on their archived blood samples. In this pilot study, the antigen identified the people who carried the corresponding specific strain of the T. cruzi parasite."

Expanding to other diseases

Having single tests to distinguish different strains paves the way for future research on the relationship between disease prognosis and the different strains of T. cruzi infection.

The technique used could also be applicable to a wide range of other diseases, according to co-author Professor Haslam: "Our work clearly shows the importance of the glycosylation of the synthetic antigens used in Chagas disease diagnostics. This is an important lesson for improving diagnostics for other infectious diseases, including COVID-19."

Development of new tests for diagnosing Chagas disease in the early stages, when treatment would be most effective, has remained complicated for so long, in part, because affordable diagnostics for neglected diseases are not attractive profit-making opportunities for large companies.

TroZonX17 will now use the new specific antigens to support development of a fuller range of affordable RDTs for widespread access to strain-specific diagnosis, even in very remote locations.

NUI Galway receives Grant to develop Handheld Device for Rapid COVID-19 Testing

Researchers from NUI Galway and the University of Wyoming have received a grant of €199,720 from the Health Research Board to develop a handheld device for rapid detection of SARS-CoV-2, the virus that causes COVID-19. The device, which they aim to have available early next year, will also test for antibodies to the virus in human samples.

The test device is already being sold and the research team are currently developing a COVID test to work with it in order to produce and distribute large quantities within a short period of time. The rapid test will be capable of being administered by anyone, such as airport officials or school principals.

Professor Gerard Wall, of Microbiology, College of Science and Engineering and SFI Research Centre for Medical Devices (CÚRAM) at NUI Galway, is leading the research along with Professors Patrick Johnson and Karen Wawrousek from the University of Wyoming’s Department of Chemical Engineering.

Professor Wall will employ a laboratory-based technique that mimics the human immune response “in vitro”, or in a test tube, to produce antibody fragments for use in the detection of the virus. The antibody fragments will enable high sensitivity and reproducibility of the device and can be produced in large quantities in bacterial cells.

Professors Johnson and Wawrousek will attach the antibody fragments to nanoparticles for incorporation into a hand-held, battery-operated device that will carry out rapid detection of the virus using a laser, in approximately 15 minutes.

Professor Gerard Wall, NUI Galway, said: “Rapid detection of the virus on-site will allow potentially infectious people to be identified so that decisions on isolation and treatment can be made immediately. There are clear applications for this type of device in airports, workplaces or schools, among other locations.”

Professor Patrick Johnson, University of Wyoming, said: “Our test will have higher sensitivity than other rapid tests and will not require any sample preparation. The idea is to have an accurate, portable, on-site test with results within 15-20 minutes. This will allow rapid answers while the person is still present, enabling immediate intervention and treatment.”

Samples can be collected from saliva, nasal swab or blood. The samples will then be placed in glass vials and inserted into hand-held instruments, called Raman spectrometers, for analysis.

The project team plans to use Raman spectrometers developed by entrepreneur Keith Carron, CEO of Metrohm Raman in Laramie, Wyoming and will work with Noah Hull, Microbiology Laboratories manager at the Wyoming Public Health Laboratory to validate the assay against known positive and negative samples.

SEKISUI Diagnostics Announces Launch of the OSOM® Ultra Plus Flu A&B Test in Europe

SEKISUI Diagnostics announces it has received CE Marking (Conformité Européenne) for the OSOM® Ultra Plus Flu A&B Test and has begun marketing in Europe.  

The test utilizes traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument. It is intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.  

"The CE Marking of the OSOM® Ultra Plus Flu A&B Test expands our flu portfolio allowing us to provide a more accurate rapid influenza test kit to many different institutions in more countries. The WHO acknowledges that rapid influenza testing can have important case management implications, specifically allowing the use of influenza antivirals. Other benefits may include the isolation, clustering and analysis of confirmed cases to help prevent outbreaks in the hospital setting and the reduction of the inappropriate use of antibiotics," said Robert Schruender, President and CEO of SEKISUI Diagnostics. "Accurate diagnosis of influenza is critical to rule in or rule out the flu and can help guide healthcare professionals when trying to diagnose other respiratory infections.  This is especially important in our current situation where SARS-CoV-2 Tests are still not widely available.  We are proud to be able to provide another diagnostic tool which can help protect patients and our communities."  

SEKISUI Diagnostics offers solutions to address the varying needs of customers to help improve patient outcomes, maximize clinical efficiencies, and reduce operational budgets. "Reflecting on the unprecedented respiratory season last year, we have seen the value of tests that can respond to high volume clinical demand no matter where testing occurs," said David Morris, PhD, Sr. Product Manager. "Rapid, point-of-care testing continues to be an essential tool in the healthcare system's ability to respond to surges in testing demand and to reduce the spread of respiratory infections." 

Testing patients provides valuable information to clinicians that enables treatment decisions and reduces the risk of prescribing unnecessary antivirals, antibiotics or allows them to be referred on for more extensive testing if needed.  

About SEKISUI Diagnostics: 

SEKISUI Diagnostics is a global diagnostics company committed to improving patient's lives by providing innovative medical diagnostics to physicians and laboratories through a global commercial network.  Product lines include clinical chemistry and coagulation systems/ reagents, rapid test kits and point-of-care systems as well as enzymes and specialty bio-chemicals.  

FDA Authorizes First COVID-19 Test for Self-Testing at Home

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only. 

The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”

An important component to successful at-home testing is the ability to efficiently track and monitor results. As noted in this EUA, prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state and federal requirements. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting.

Diagnostic testing remains one of the pillars of our nation’s response to COVID-19. The FDA continues its public health commitment to pursue new approaches that help make critical tests available to more Americans through EUA authority. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

HHS Launches Pilot Program of Fast Molecular POC Test for COVID-19

The U.S. Department of Health and Human Services (HHS) has launched a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes.

Used successfully as the primary molecular point-of-care (POC) test to control the spread of COVID-19 within in the National Basketball Association “bubble,” as well as by leading healthcare providers in the U.S., the nasal swab POC test generates results in about 20 minutes. Currently, molecular COVID-19 tests provided by HHS must be sent to a laboratory for interpretation, which can take two to three days.

During the week of November 9, HHS distributed 27,000 test kits, which include the Cue Sample Wand (nasal swabs) and the Cue COVID-19 Test Cartridges, and 600 Cue Health Monitoring Systems (Cartridge Readers) as follows: 4,500 test kits and 100 cartridge readers each to Florida, Louisiana, New Jersey, and Texas, and 9,000 test kits and 200 cartridge readers to Alaska. Alaska received a greater quantity of components due to the remote nature of access to testing. The tests will also be used internally at the Department of Defense (DOD).

“The Cue Health testing system will undoubtedly be a valuable addition to our testing ecosystem,” said HHS Assistant Secretary for Health ADM Brett Giroir, M.D. “Having a highly specific and sensitive POC molecular test could dramatically improve infection control at nursing homes and other institutional settings especially.”

Currently, HHS sends millions of point-of-care rapid antigen tests that have emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to states, nursing homes, and others. These antigen tests, which detect specific proteins from the SARS CoV-2 virus, are inexpensive (free from the federal government) and provide same-day results – often within minutes.

Antigen tests are critical for quickly identifying people who are infected. They are used in nursing homes and other congregate care settings in which staff must be tested frequently for infection control. Although they are highly accurate, antigen tests can have false positives. In some cases — for example, when an antigen test gives a positive result for a person in a low incidence area who does not have symptoms or known exposure – the results are verified by a molecular test.

Similarly, a person with a negative result where there is a high incidence of infection, might have a follow-up molecular test to confirm the results. The laboratory-based molecular tests – which HHS has also provided to states – may take two to three days; therefore, the person tested would be required to isolate until the results are confirmed or, in the case of a false negative, risk infecting patients, colleagues, family members, or others.

“Our strategy continues to be to get the right test to the right person at the right time,” Giroir added. “We recommend that nursing homes and other institutions follow a layered approach to testing – using rapid, inexpensive, and frequent point-of-care tests for screening staff and verifying the results with more sophisticated molecular tests when the situation warrants.”

“With Cue’s COVID-19 Test, verifying the antigen test results can be done on the spot in many cases,” he added. “The pilot program will help us determine how well the Cue test will be adapted in institutions and communities.”

The pilot program is part of a $481 million contract with Cue Health, Inc., awarded October 13 by HHS in collaboration with the Department of Defense (DoD). The public-private partnership enables Cue to expand its industrial base and increase domestic production to 100,000 COVID-19 test kits per day by March 2021. The contract includes delivery of 6 million COVID-19 tests and 30,000 cartridge readers to the U.S. government to support the domestic COVID-19 response.

The Cue COVID-19 Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on June 10, 2020. The test is performed by a health professional under the supervision of an authorized laboratory operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens, and only for the duration of emergency use declaration.

The Cue Health platform was developed and validated with funding awarded by the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), starting in 2018 for the development of a molecular influenza test, with the option to expand the effort to include coronaviruses on March 31, 2020, BARDA announced its $13.6 million collaboration with Cue to accelerate the development, validation and manufacturing of Cue’s COVID-19 test.

Tuesday, October 27, 2020

Novel Method Can Test the Efficacy of Antibacterial Drugs on Infectious Microbes

A rapid and simple method for testing the efficacy of antibacterial drugs on infectious microbes has been developed and validated by a team of Penn State researchers.

Antimicrobial resistant infection is one of the major threats to human health globally, causing 2.5 million infections and 35,000 deaths annually, with the potential to grow to 10 million deaths annually by 2050 without improved techniques for detection and treatment.

Several rapid testing techniques have been developed, but they do not live up to the reliability of the gold standard technology, which requires 18 to 24 hours for reliable results. In many cases, patients need to be treated with antibiotics in a crisis, leading clinicians to prescribe broad-spectrum antibiotics that may actually lead to greater drug resistance or unacceptable side effects.

Compared to other methods of detection, our method does not require complex systems and measurement setups. Its simplicity and low cost are among the advantages and coupling our technology to machine learning makes the accuracy of our method comparable to the gold standard method and much better than other rapid methods."

The team tested their method against three strains of bacteria, including a resistant strain, to prove its effectiveness in the lab. Upon further development and validation with a broader range of pathogens and antibiotics, their method can allow physicians to prescribe the minimum dosage of the necessary drug, called the minimum inhibitory concentration (MIC) in a timely fashion.

A phenomenon that other tests fail to account for is that bacteria may initially appear to be dead, but then can revive and multiply after many hours. The team's technology, augmented by machine learning, can predict whether the bacteria will revive or are actually dead, which is critical for accurate determination of the MIC value.

Their technique is called dynamic laser speckle imaging. Zhiwen Liu, professor of electrical engineering and the second corresponding author explains the technology: "The main advantages of our method are the speed and simplicity.

You shine a laser beam on the sample and get all of these light scattering speckles. We can then capture these images and subject them to machine learning analysis.

We capture a series of images over time, which is the dynamic part. If the bacteria are alive, you are going to get some motion, such as a small vibration or a little movement. You can get reliable, predictive results quickly, for example within one hour."

In addition to the immediate benefits provided to the patient, the lower concentration of drugs entering the water supply translates to less pollution to the environment, he says.

"One of the exciting aspects of this research has been its multidisciplinary nature. As an electrical engineer, I find it quite fascinating to work on designing and developing an optical diagnostic system as well as performing microbiology assays," said Keren Zhou, the co-lead first author on the paper and a Ph.D. student in electrical engineering.

His co-lead author, Ph.D. student Chen Zhou, added, "We plan to further develop our technique to a low-cost and portable platform, which would be especially beneficial for resource-limited settings."

In this work, the researchers also collaborated with Jasna Kovac, assistant professor of food science, to validate their findings with gold standard microbiology methods.

Journal reference: Zhou, K., et al. (2020) Dynamic Laser Speckle Imaging Meets Machine Learning to Enable Rapid Antibacterial Susceptibility Testing (DyRAST). ACS Sensors.

SQI Diagnostics Updates Clinical Progress on Novel COVID-19 Tests

SQI Diagnostics Inc., a precision medicine company that discovers, develops, manufactures and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, today updated the Company's clinical development progress for its three novel Covid-19 tests, highlighted by confirmation from the U.S. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx™ Severity Triage Test and its COVID-19 RALI-fast™ Severity Triage Point-of-Care (POC) Test.

"We are currently advancing three important COVID-19 tests through clinical development with the intent to submit applications for Emergency Use Authorization to the FDA for all three, said Mr. Robert L. Chioini, Chief Executive Officer of SQI. Mr. Chioini further stated, "We believe our COVID-19 Antibody Home Collection Test will be differentiated by providing both speed and accuracy, delivering results in 24-48 hours with > 99% accuracy. Our COVID-19 Severity Triage Tests are unique because both have the potential to help save lives while reducing the burden and cost on healthcare systems. SQI is committed to our goal of making rapid diagnostic testing widely available to clinicians, patients, consumers and industry to help improve lives."

SQI's RALI-dx™ COVID-19 Severity Triage Test measures five critical biomarkers including IL-6 in approximately 50-minutes to help clinicians determine severe inflammatory response in patients with COVID-19 and whether they require hospital admission or not. SQI intends to submit RALI-dx for EUA to FDA in late Q4 2020. The RALI-dx™ COVID-19 Severity Triage Test is expected to be used primarily in hospital emergency departments upon FDA approval.

SQI's RALI-fast™ COVID-19 Severity Triage POC Test measures the key critical biomarker IL-6 in approximately 15-minutes to help clinicians determine severe inflammatory response in patients with COVID-19 and whether they require hospital admission or not. SQI intends to submit RALI-fast™ for EUA to FDA in late Q1 2021. The RALI-fast™ COVID-19 Severity Triage POC Test is expected to be used primarily in hospital emergency departments and urgent care centers upon FDA approval.

SQI's COVID-19 HOME Antibody Test identifies the presence of IgM, IgA and IgG antibodies of SARS-CoV-2 in individuals suspected to have been infected with COVID-19 and those wanting to know if they have been exposed. The test is > 99% accurate with results delivered conveniently in 24-48 hours. intends to submit its EUA to FDA in early Q1 2021. The COVID-19 HOME Antibody Test is expected to be used widely, including by school systems, businesses, sports teams, government and consumers at home.

Thursday, October 15, 2020

20/20 Launching First COVID-19 Rapid Antibody Test Authorized by FDA for Point-of-Care Use

20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc., announced today that it is now accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits. These kits were the first to receive an emergency use authorization (EUA) from the FDA for point-of-care (POC) use with fingerstick blood samples on September 23. According to the FDA announcement “this authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.” “Authorizing POC serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D.

The company is now accepting orders from pharmacies, urgent care centers, and doctor’s offices, especially those servicing first responders.

The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 in blood, which is the cause of COVID-19. IgM antibody generally begins to rise within 1 week of initial infection and IgG typically appears about 14 days after infection.

“As vaccines begin to enter the market over the coming months, we believe there will be increasing demand by individuals and their healthcare providers for antibody tests,” said Michael Lebowitz, Ph.D., 20/20’s Chief Scientific Officer. “The presence of serum antibodies against an infectious agent may be an indicator of immunity against said agent. Until such time as the durability of the immune response is established, it will be important for both those who have had a prior infection as well as those who have received a vaccine to be monitored on a regular basis for the presence of antibodies. Such information can be used to suggest that an individual may benefit from a boost with the vaccine”.

20/20 also plans to conduct studies to validate the use of an at-home fingerstick blood collection device together with a quantitative antibody test awaiting an EUA from the FDA. Quantitative tests permit individuals to monitor changes in their antibody levels over time and may help assess susceptibility to future infections. The company, which specializes in developing machine learning algorithms associated with laboratory tests, will seek to build algorithms to help predict and quantify the strength and durability of immune response.

About 20/20 GeneSystems: 

20/20 GeneSystems, Inc. is a Rockville, MD based company focused on innovative diagnostics and detection products. In addition to the company’s blood tests for early cancer detection, 20/20 has also commercialized its patented BioCheck® detection kit to help fire departments and other emergency response organizations screen suspicious powders.

Monday, September 28, 2020

Vox Biomedical Receives NIH Award for Rapid COVID-19 Diagnostic Development

Vox Biomedical announced that it has received a supplemental award from the National Institute on Drug Abuse, part of the National Institutes of Health, to expand upon the breath analyzer technology, which it is developing for the detection of marijuana and opioids, to include a rapid, sensitive and accurate breath diagnostic test for COVID-19.  

The award calls for a biomarker discovery effort to determine the exhaled breath molecular species most suitable for use as a COVID-19 biomarker and methods of capture that can be implemented within the safety paradigm governing COVID-19 testing.  

Exhaled breath is a rich matrix of volatile organic compounds, or VOCs, originating from human metabolism as well as aerosol condensates and bacterial and viral species suspended in micro-water droplets and inflammatory products. Towards the end of developing a breath-based COVID-19 diagnostic, Vox Biomedical scientists will investigate biomolecules associated with the inflammatory and metabolic changes caused by COVID-19 infection. In addition, Vox Biomedical scientists will consult with Dr. Scott Lukas of McLean Hospital and Harvard Medical School to determine substance abuse molecules that can be simultaneously captured along with a COVID-19 biomarker in the exhaled breath. This effort will allow future studies to determine the effect of COVID-19 infection on substance abuse communities.

Upon identification of potential COVID-19 breath-based biomarkers detection, efforts will concentrate on breath collection and virus detection utilizing Vox’s current portable instrument design. An FDA regulatory approval strategy for such a COVID-19 diagnostic technique will be developed to aid in the rapid deployment of this diagnostic technique once validation of a COVID-19 biomarker has been established.