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.