COVID-19 Tests | Wish List

trader32176
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IMCRC launches new funding initiative with an Australian first rapid COVID-19 test

11/12/20


https://www.news-medical.net/news/20201 ... -test.aspx


Innovative Manufacturing Cooperative Research Centre (IMCRC) has launched its new funding initiative, IMCRC activate, with an Australian first — the development of a rapid COVID-19 test that uses optical technology.

Designed to provide a much-needed stimulus to Australian manufacturing businesses in the wake of COVID-19, IMCRC activate stimulates and fast-tracks R&D investment, offering access to valuable expertise and matched cash funding between $50,000 and $150,000.

The first approved project of the initiative is led by Alcolizer, a Perth-based company developing a rapid saliva test for SARS-CoV-2 virus antigens using its existing drug testing technology.

Alcolizer’s partnership with IMCRC and research collaboration with the University of Technology Sydney (UTS) will see the project accelerate quickly in the face of the global health pandemic, evolving from a proof of concept to secure Good Manufacturing Practice (GMP) readiness in just four months.

As Australia emerges from the worst of the COVID-19 crisis, providing valuable and strategic support for shorter-term research projects in advanced manufacturing and digital technologies is a priority for IMCRC.

" As the fourth largest industry in Australia, manufacturing is critical to rebuilding the health of our economy.

- David Chuter, CEO and Managing Director, IMCRC

COVID-19 highlighted some serious capability gaps in the industry, and now we must focus on using our Australian resources and R&D strengths for future growth. The IMCRC activate funding initiative has been designed to do just that — provide funding and pathways for manufacturers to recover and thrive.

We’re thrilled our first approved project has been so successful to date and has the potential to provide much needed health, social and economic benefits in the fight against COVID-19. We hope this new funding initiative will shine a light on the need for broader investment in Australian manufacturing R&D.”

" The IMCRC activate initiative has been absolutely instrumental in our progress developing the prototype for this test. We have been able to boost our manufacturing capabilities and accelerate the diversification of our business into a new area of opportunity.”

- Roger Hunt, General Manager, Alcolizer

Laboratory trials using the Alcolizer COVID-19 test prototype are expected to begin within two months. More information about the project is available at https://www.uts.edu.au/news/health-scie ... g-distance.
About IMCRC activate

IMCRC activate is a new initiative designed to help Australian manufacturers take action and gain a competitive edge in the post COVID-19 world.

To be eligible for IMCRC activate funding, projects must:

Be industry-led, deliver clear manufacturing outcomes and be completed within six to 15 months
Be undertaken by one of IMCRC’s partner research organisations
Apply Industry 4.0 technologies and digital business models
Move the project through ideally two Manufacturing Readiness Levels (MRLs)
Ideally involve other Australian manufacturing SMEs as collaborators
Address sustainability and/or national needs where possible.

More information is available at https://www.imcrc.org/activate/.
trader32176
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Bioelectronic rapid test for COVID-19

11/18/20


https://www.news-medical.net/news/20201 ... ID-19.aspx


The ability to contain the coronavirus 2019 (COVID-19) pandemic is limited in the ability to detect at the right time, monitor effectively, and target to cure. However, severe acute respiratory syndrome virus coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, is far from under control. So far, it has infected over 55.57 million individuals and claimed the lives of over 1.33 million globally. Many people are symptom-free but infective carriers - this dangerously augments the transmission of the virus.

Current detection methods involve: 1) RT-PCR (Reverse Transcription Polymerase Chain Reaction), where the results take about a day or more due to complex sample processing in specialized, well-instrumented laboratories, and 2) Immunoassays, that can detect viral loads above 50 million copies/mL (useful for the isolation of highly infectious individuals). The lack of sensitivity and robustness against sample processing and reaction times delays isolating infected carriers - severely hampering the suppression of infection chains.

A recent study presents a bioelectronic sensor platform to detect protein at the single-molecule level that is simple, rapid, and robust enough for widespread POC (point-of-care) or bedside application. The research published as a preprint on the medRxiv* server introduces a modular nanobody-organic electrochemical transistor sensor that provides results after a 10 minutes exposure to 5 µL of unprocessed samples, maintains high specificity and single-molecule sensitivity in human saliva or serum.

Instead of the classic antibodies (or antibody fragments), nanobodies are used here. Nanobodies are compact recognition modules made from the antigen-binding domain (VHH) of an unusual class of heavy chain-only antibodies found in Camelids. The sensor used in this study combines a new solution-processable organic semiconductor material in the transistor channel with the high-density and orientation-controlled bioconjugation of nanobody fusion proteins on disposable gate electrodes.

This study is claimed to be the first where nanobodies are combined with OECT (organic electrochemical transistors) technology. Key features in this process are (i) the use of a novel organic semiconductor that allowed for the first practical implementation of an accumulation-mode OECT and (ii) the controlled biofunctionalization of the sensor surface with (iii) custom-engineered nanobodies.

In this study, the researchers from King Abdullah University of Science and Technology (KAUST), King Faisal Specialist Hospital & Research Center, KAUST Solar Center (KSC), Saudi Arabia, the University of Oxford, Imperial College London, United Kingdom, and Université de Montpellier, France, tested for three different target proteins. To optimize multiple parameters of the sensor, they used the anti-GFP nanobody-conjugated gate electrode as a model. The sensor responds within a dynamic range of six orders of magnitude. This sensitivity is on-par with commercial colorimetric ELISA assays, which, however, take hours to complete, require larger sample volumes, and have a far narrower dynamic range.

Thus, the researchers show that this platform is broadly applicable and is only limited by the availability of antigen-specific nanobodies. Usually, the currently available organic mixed (semi)conductors are not stable; the researchers demonstrate that this sensor has exceptional operational and environmental stability.

The researchers find that observation of binding at such low concentrations is due to the high-density nanobody-functionalized gate electrode that operates as a kinetic trap for target molecules. The kinetic stability of the complex (koff) (~1.5 × 10-4 s-1 corresponding to 80 min half-life) and the diffusion rate dictate such high sensitivity observed in this study.

The sensor is reusable, easy to manufacture, and highly modular. It can detect specific single protein molecules reliably on millimeter-sized disposable electrodes in uncontrolled, ambient environments. This sensor is also quantitative and distinguishes concentrations over 8 to 10 orders of magnitude (attomolar to nanomolar).

The interdisciplinary team demonstrates that the platform's functioning is fast; from sample to test results, it takes less than 15 min. It does not require sample preparation; unprocessed saliva or serum samples can be directly used.

The researchers confirmed single-molecule sensitivity and high specificity of SARS-CoV-1 or MERS nanobody-functionalized OECTs in buffer samples and saliva in detecting SARS-CoV-2 or MERS-CoV. They have further validated the sensor's performance with the clinical unprocessed nasopharyngeal swab and saliva samples from COVID-19 patients and healthy volunteers and demonstrated a sensitivity comparable to RT-PCR methods. RT-PCR often detects membrane-associated RNA long after the infection has cleared from the body.

In conclusion, the researchers have bioengineered a nanobody-functionalized OECT sensor, introducing a label-free electrochemical immunosensing platform with single protein molecule sensitivity and a broad dynamic range. The sensor can also be rapidly adapted to any target for which nanobodies exist or can be raised.

"The speed, performance and versatility of our nanobody functionalized OECT, and its compatibility with many sample types, suggest that this platform can complement or replace a wide range of clinical and non-clinical diagnostic assays," the researchers write.

The COVID-19 crisis highlights a critical limitation of our current POC diagnostics toolbox. This platform introduced here could not have come sooner.
trader32176
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FDA approves first COVID-19 diagnostic test for at-home use

11/18/20


https://www.news-medical.net/news/20201 ... e-use.aspx


Today, 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. We look forward to proactively working with test developers to support the availability of more at-home test options."

- Jeff Shuren, M.D, J.D, Director, Center for Devices and Radiological Health, Food and Drug Administration

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.
Howzitgoing
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Find a Testing Location Near You

COVID-19 Testing By State

COVID-19 tests are available at no cost nationwide at health centers and select pharmacies. The Families First Coronavirus Response Act ensures that COVID-19 testing is free to anyone in the U.S., including the uninsured. Additional testing sites may be available in your area. Contact your health care provider or your state or local public health department for more information.

https://www.hhs.gov/coronavirus/communi ... index.html
trader32176
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Biosensor assay SARS-CoV-2 antibody test may predict COVID-19 severity in patients

11/24/20


https://www.news-medical.net/news/20201 ... ients.aspx


The coronavirus disease 2019 (COVID-19) pandemic continues to spread across the globe. To date, there have been over 59.17 million confirmed infections and over 1.39 million deaths. The causative agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in Wuhan, China, in December 2019.

Understanding the scale of the virus and its prevalence in a population is an essential part of containing its spread. Therefore, accurate, efficient and affordable testing is crucial in implementing effective social distancing measures, managing local outbreaks and breaking chains of transmission.

But better testing with higher sensitivity can also help predict COVID-19 severity in patients early on in their bout with the virus. Understanding early a patient’s likely prognosis with the disease through high sensitivity testing could allow for necessary therapeutic interventions that would mitigate its potential impact on those vulnerable to more severe or critical cases.

Research laboratories have been working round the clock to develop better detection tests with high specificity and sensitivity. These tests have aimed to detect the neutralizing antibodies (NAbs), which block the receptor-binding domain (RBD) of the spike (S) glycoprotein of SARS-CoV-2.

This NAb-RBD-binding blocks the virus’s protein from interacting with the human angiotensin-converting enzyme 2 (ACE2) receptor, found abundantly in epithelial cells lining the respiratory and intestinal tracts, which is the means by which the virus gains entry into the host cell.

Early humoural immune response to SARS-CoV-2 may predict the clinical outcome (recovery, severity, or mortality). However, due to the lack of highly sensitive serologic testing methods during the key early days of infection, this speculation has not yet been fully investigated.

In a recent preprint paper released on the medRxiv* server, researchers in New York, USA, have found an association of mortality with an early humoral response to SARS-CoV-2 infection within the first few days after onset of symptoms (DAOS), using a highly sensitive and automated testing-on-a-probe (TOP) biosensor assays for SARS-CoV-2.

The study

The researchers report two sensitive and automated TOP biosensor assays for SARS-CoV-2 viral-specific total antibodies (TAb) and surrogate neutralizing antibodies (SNAb). The competitive binding assay detects the SARS-CoV-2 viral-specific total antibodies (TAb) and surrogate neutralizing antibodies (SNAb), employing an RBD-coated quartz probe.

It also uses a Cy5-Streptavidin polysaccharide conjugate to improve sensitivity and minimize any interference.

The total assay time is 16 min. The researchers also designed the assay with disposable cartridges containing pre-dispensed reagents, meaning it requires no liquid manipulation or fluidics during testing.

The researchers tested the clinical utility of the biosensor by evaluating early antibody responses in real-time polymerase chain reaction reverse transcription (RT-PCR) COVID-19-positive hospitalized patients. The study cohort involved 120 adult patients, who were hospitalized at New York Presbyterian/Weill Cornell Medical Center (NYP/WCMC) from March 8 to April 7, 2020.

COVID-19 severity is observed with different outcomes, leaving doctors, healthcare givers and researchers with no clue to the possible outcome during the treatment or hospitalization of patients. Discrepancies in the observed studies so far depend on a variety of factors.

For the first time, the researchers demonstrate in this study that SARS-CoV-2 TAb and SNAb (upon initial presentation) are risk indicators for in-hospital mortality. This study uses the TOP assay to associate the antibodies present on the first day of a hospital visit and subsequent mortality.

The researchers found that the patients who did not present high antibodies during the hospital visit were at a higher risk of in-hospital mortality. Early after infection, the NAbs, if present, avoid severe disease manifestation - by limiting the number of host cells that become productively infected.

They show that the higher antibody levels are associated with a lower viral load.

Their findings agree with recent reports that early immunologic protection in COVID-19 patients is important. These antibodies that appear early in the infection stage can be postulated to protect the patient from the severity of infection and mortality; either by playing a protective role directly or suppressing the SARS-CoV-2 replication indirectly.

A reliable and versatile serological or antibody test detects infection early on. This type of test is still not available on the market.

Conclusion

This study reports a novel, rapid, highly sensitive and fully automated biosensor technology (TOP) that can be adapted to the clinical laboratory setting. The new assays detect early SARS-CoV-2 antibodies on the first day of a hospital visit. The findings show that the levels of SARS-CoV-2 antibodies are inversely associated with the subsequent COVID-19 mortality.

The associations between early antibody response to SARS-CoV-2, initial viral load and eventual in-hospital survival are consistent with strong, early humoral immunity countering SARS-CoV-2 replication - this could have significant implications for managing their immediate and future care.

The researchers believe future studies will explore if these new sensitive and specific assays could potentially monitor the efficacy of antiviral therapies as well as assess antibody responses during vaccine trials.
*Important Notice

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
trader32176
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New A.I. is fast and accurate at detecting COVID-19 from chest X-rays

11/24/20


https://www.news-medical.net/news/20201 ... -rays.aspx


A team of researchers at Northwestern University, Illinois, USA, have innovated a platform that uses artificial intelligence (A.I.) to detect COVID-19 at higher levels of accuracy than specialized thoracic radiologists.

The breakthrough will likely be instrumental in preventing the spread of the virus, particularly amongst hospital patients and staff, by providing a rapid and accurate method for screening patients admitted to hospital either with or without COVID-19 symptoms by merely scanning their chest x-rays.

The technology will act as an early warning system, highlighting those who need to self-isolate even before symptoms develop and, additionally, picking up on those who may have never been aware of their need to isolate.

An early warning system

The study, published this month in the journal Radiology, proposes that the A.I. could be used as a safe and inexpensive screening method that would not replace actual testing but act as an extra route to highlighting those who need to isolate who otherwise may be missed, or would recognize their symptoms much later, after exposing many more people to the virus.

The platform can detect signs of the virus in seconds, enabling people to begin isolating before getting results from testing, which generally takes hours or even days.

Dr. Ramsey Wehbe, a cardiologist and postdoctoral fellow in A.I. highlights the role of the system not as a diagnostic tool but rather as a method of flagging those who show signs of COVID-19 and may need to isolate and receive further treatment.


" A.I. doesn't confirm whether or not someone has the virus. But if we can flag a patient with this algorithm, we could speed up triage before the test results come back."

Differentiating COVID-19 from pneumonia and other illnesses

COVID-19 infections can often be recognized by characteristic patterns displayed in their chest X-rays. Frequently, the images appear patchy or hazy, include 'bilateral consolidations,' and show signs of inflammation and extra fluid.

However, it is difficult even for specialized medical professionals to differentiate chest X-rays of COVID-19 patients from those of patients with pneumonia, heart failure, and other illnesses, as the lungs can look very similar.

To overcome this issue, the team of scientists developed and trained their A.I. algorithm on over 17,000 chest X-rays sourced from the most extensive published clinical dataset available from the time of the pandemic. 5,445 of the images in the data set were taken of patients who'd tested positive for COVID-19.

The accuracy of the A.I. system, known as DeepCOVID-XR, was compared with experienced cardiothoracic fellowship-trained radiologists on their analysis of 300 test images. The results revealed that the A.I. was not only significantly faster at analyzing the images; it was also more accurate.

On average, radiologists spend two-and-a-half to three-and-a-half hours to analyze the set of images, whereas the A.I. took around 18 minutes. Additionally, the accuracy of the radiologists' reading was between 76 and 81%, whereas the A.I. achieved 82%.

It should be noted that the A.I. system, while fast and accurate at reading the characteristics of COVID-19 from X-rays, would not be able to highlight all patients with the virus via these images as not every COVID-19 patient manifests symptoms on their lungs, especially early on.

The newly developed algorithm has been made publicly available with the intention of allowing other research teams to train the system with new data and develop its capabilities. The A.I. will likely be an invaluable tool to be used alongside other methods in preventing the spread of COVID-19.
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Digital warm-start CRISPR assay enables sensitive quantitative detection of SARS-CoV-2 in clinical samples

11/24/20


https://www.news-medical.net/news/20201 ... mples.aspx


In a recent medRxiv* preprint paper, researchers from the University of Connecticut Health Center in the United States unveil their digital warm-start CRISPR (WS-CRISPR) method for stringent and sensitive quantitative detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in clinical samples of patients with coronavirus disease (COVID-19).

Since effective antiviral treatment and fully validated COVID-19 vaccines are thus far unavailable in our battle against COVID-19, precise and accurate quantification of the SARS-CoV-2 virus plays a pivotal role in appraising infectivity parameters and controlling the ongoing pandemic.

In order to quantify SARS-CoV-2, probe-based reverse transcription-polymerase chain reaction (RT-PCR) is currently used as the gold standard technique due to its relatively high sensitivity and specificity; nonetheless, it depends on expensive instruments and well-designed probes not amenable for small clinics or community health environments.

Likewise, isothermal amplification methods are actually intended for qualitative detection purposes or frequently exposed to either undesired non-specific amplification or false positive signals.

This is where CRISPR-Cas-based nucleic acid detection comes into play. Still, the question is whether it can be tinkered to enable accurate quantification without undesired premature target amplification and subsequent overestimation if digital detection is used.

A research group from the United States, led by Dr. Xiong Ding from the Department of Biomedical Engineering at the University of Connecticut Health Center in Farmington, described a digital WS-CRISPR assay that promises valid and reliable quantification of SARS-CoV-2 nucleic acids in clinical samples.

Building blocks of the new method

In this exciting scientific endeavor, the researchers took advantage of an inaugural one-pot warm start CRISPR reaction, which combines a low-temperature reverse transcription dual-priming mediated isothermal amplification (RT-DAMP) and CRISPR-Cas12a-based detection.

More specifically, to couple these two different reaction systems into one-pot, pyrophosphatase has been added to maintain a constant concentration of magnesium ions by degrading the magnesium pyrophosphate byproduct.

In addition, phosphorothioated inner primers have been used to enable efficient reverse transcription isothermal amplification at rather low-temperatures (such as 52 °C) in this study.

Finally, by partitioning the one-pot reaction mix into sub-nanoliter microreactions using QuantStudio 3D digital chips, this research group developed a digital CRISPR assay that enables sensitive and dependable quantification of SARS-CoV-2.

Moving the goalpost of CRISPR diagnostics


In comparison to previously reported CRISPR-based nucleic acid techniques, this digital WS-CRISPR assay provides several exceptional advantages. First and foremost, this is an inaugural demonstration of a one-pot CRISPR assay that combines Bacillus stearothermophilus (Bst) DNA polymerase-based reverse transcription isothermal amplification with CRISPR-Cas12a detection – without the need for higher reaction temperature and longer nucleic acids.

Furthermore, the method is typically initiated at an elevated temperature (above 50 °C), addressing the issue of undesired premature target amplification in digital detection, as well as displaying 10-fold higher sensitivity and high detection specificity when compared to tube-based bulk assay format.

By targeting the nucleoprotein gene of SARS-CoV-2, it is possible to quantify as low as 5 copies of SARS-CoV-2 RNA per microliter in the chip with the use of digital WS-CRISPR assay. Moreover, the quantification can occur in clinical samples, enabling the assessment of COVID-19 infectivity and antiviral drug efficacy.

Finally, the proposed digital WS-CRISPR assay displays a high tolerance level to inhibitors and can be used to directly detect the virus in crude saliva samples, circumventing the need for RNA extraction. This will, in turn, facilitate the COVID-19 diagnosis and lower the infection risk in health workers.

A glimpse into the future


"As the first clinically validated digital CRISPR assay, our digital WS-CRISPR assay provides a reliable, sensitive and straightforward SARS-CoV-2 quantitative detection", emphasize study researchers in this medRxiv preprint paper. "It opens a new exploration for CRISPR-base nucleic acid quantitative detection," they add.

Notwithstanding the advantages above, a new digital chip has to be further explored and validated for digital WS-CRISPR assay in the future, with the need for additional clinical validation steps.

In addition, albeit this digital WS-CRISPR assay utilizes relatively expensive fluorescence microscopy for imaging purposes, smartphone-based portable fluorescence microscopy may become the alternative option towards onsite quantitative detection in the near future.

*Important Notice

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
trader32176
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Researchers launch study to determine effects of increased access to rapid COVID-19 testing

11/24/20


https://www.news-medical.net/news/20201 ... sting.aspx


Researchers at the University of Chicago Medicine and the University of Illinois at Chicago (UIC) are launching an investigational study to determine the effects of increased education and access to rapid, FDA-approved COVID-19 testing on community perceptions, access, and use of COVID-19 testing resources.

The study will be funded by $2M in support from the National Institutes for Health RADx-UP program. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the RADx Underserved Populations (RADx-UP) program supports research that aims to better understand COVID-19 testing patterns among underserved and vulnerable populations; strengthen the data on disparities in infection rates, disease progression and outcomes; and develop strategies to reduce the disparities in COVID-19 testing.

The research will be led by Ayman Al-Hendy, MD, professor of obstetrics and gynecology at UChicago Medicine, and Renee Taylor, PhD, professor of occupational therapy and Nahed Ismail MD, PhD, D(ABMM), D(ABMLI), professor of pathology and medical director of clinical microbiology at the University of Illinois at Chicago. The investigators plan to leverage existing university-community partnerships and expertise in clinical microbiology, community engagement, and epidemiological infrastructures to expand access to rapid COVID-19 testing.


" There are testing deserts in Chicago, where many people don't have easy or affordable access to testing. We can reach individuals who maybe don't have health insurance or are concerned about having a COVID-19 test on their medical record and provide them with an easy and private opportunity to get tested."

- Renee Taylor, PhD, professor of occupational therapy, University of Illinois at Chicago

The project includes collaboration with community members to co-create advertisements to recruit other participants into the trial as well as a mobile health web app, called the mHealth Literacy and Outreach Suite, that will allow individuals to not only privately order testing, but also learn how to prevent the spread of COVID-19 and care for themselves if they fall ill.

Investigators are also sending out kits so participants can collect their own samples and send them to be tested at UIC. Sample collection can be performed rapidly at home with a nasal swab, without the discomfort of the typical nasopharyngeal swab, before sending the sample to the central lab for testing.

The team hopes that the privacy offered by these options, as well as the community advocacy, will help improve the public perception of receiving a COVID-19 test.

"Many people don't trust the test, are concerned about the expense, or are worried that they'll be forced out of work or forced to isolate if they have a positive test, which is creating a lot of stigma," said Ismail. "We need to expand our testing in a community setting where people have some privacy, and the mHealth Suite provides that, as well as overcoming issues of cost."

Al-Hendy credits the skills of the interdisciplinary team and their pooled community networks for making this collaborative effort possible. "The collaboration between UIC and UChicago Medicine will allow this project to reach many underserved populations," he said. "Our two institutions already both have robust relationships within our local communities, which will help expand the impact of this project and provide a valuable resource to these communities."

UChicago Medicine is one of 55 institutions that received an NIH award through the RADx-UP program to support projects designed to rapidly implement COVID-19 testing strategies in populations disproportionately affected by the pandemic. These groups include African Americans, American Indians/Alaskan Natives, Latinx, Native Hawaiians, older adults, pregnant women and those who are homeless or incarcerated.

Individuals who are interested in learning more about this study and how they can participate should contact Renee Taylor at Beatcovid19@uic.edu or by phone at 312-996-8217
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Researchers evaluate the most appropriate test for COVID-19

12/2/20


https://www.news-medical.net/news/20201 ... ID-19.aspx


Until a vaccine is available, curbing the coronavirus pandemic relies heavily on how quickly a potentially exposed individual can be tested and quarantined.

However, the current diagnostic techniques vary in reliability and relevance, so an understanding of which test is most appropriate for a given circumstance is necessary to avoid false reports.

Researchers from Van Yuzuncu Yil University, Marmara University, Yildiz Technical University, and Istanbul Yeni Yuzyil University evaluated the available diagnostic techniques and determined key steps required for better testing moving forward. They present their findings in the journal APL Bioengineering, from AIP Publishing.

" Rapid diagnosis and rapid isolation are the key factors for prevention of the pandemic."

- Oguzhan Gunduz, Study Author, American Institute of Physics

Laboratory tests that target the virus's genes -- known as real-time reverse transcription-polymerase chain reaction assays -- are currently the gold standard for testing. But according to the Food and Drug Administration, these could give false negatives.

These tests depend on the presence of antibodies, which may not have yet been developed in the early stages of infection. Since different antibodies appear at different stages, diagnostic tests must be chosen to target the appropriate immune response based on when an individual is believed to have been infected.

"There is not any available single test for the entire stage of the disease," Gunduz said. "However, I think it may be possible to detect the attack at any stage of the disease with nano-based sensor technologies."

The group emphasizes point-of-care testing as an urgent objective. These types of tests would help detect the virus on site without the need for laboratory equipment or specialized personnel, eliminating or reducing the wait time between testing and obtaining results.

"A quite sensitive test that can measure the existent tiny number of viral particles, or any parameter related to the particle -- weight, structure, charge, diameter -- can provide rapid and early diagnosis," said Gunduz.

When asked about the potential for a more comfortable testing method, he stressed that this depends on the sampling method and its sensitivity. A fingertip blood test or a saliva test could potentially be underway, though these have their own drawbacks.

"There are such tests, but they come up with accuracy and specificity issues," Gunduz said.

Source:

American Institute of Physics

Journal reference:


Alpdagtas, S., et al. (2020) Evaluation of current diagnostic methods for COVID-19. APL Bioengineering. doi.org/10.1063/5.0021554.
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FAU researchers develop simplified, rapid SARS-CoV-2 detection protocol

1/13/21


https://www.news-medical.net/news/20210 ... tocol.aspx


To properly monitor and help curb the spread of COVID-19, several millions of diagnostic tests are required daily in just the United States alone. There is still a widespread lack of COVID-19 testing in the U.S. and many of the clinical diagnostics protocols require extensive human labor and materials that could face supply shortages and present biosafety concerns.

The current gold standard for COVID-19 diagnostic testing in the U.S., developed by the U.S. Centers for Disease Control and Prevention (CDC), is quantitative PCR-based (qPCR) molecular tests that detect the presence of the viral nucleic acid. Although highly accurate, these CDC-approved tests require specialized reagents, equipment, and personnel training. In addition, multiple diagnostic kits that have been rapidly developed and introduced into the market have accuracy, cost and distribution limitations. Moreover, the test systems currently utilized are not easily scalable to a high-throughput platform to deliver the required millions of tests per day.

Given the urgent need to develop alternative reagents and approaches to provide nucleic-acid testing in the face of heightened demand and potential shortages, a research team from Florida Atlantic University's Schmidt College of Medicine has developed a simplified COVID-19 testing protocol that offers a distinct advantage over the standard viral or universal transport medium (VTM).

This testing protocol can detect minimal quantities of the SARS-CoV-2 using samples from both upper respiratory tract swabs (nasal and throat) as well as saliva, and can be used in research laboratories with minimal molecular biology equipment and expertise.

The protocol, published in PLOS ONE, utilizes TRIzol (guanidinium thiocyanate/phenol-chloroform) to purify the viral RNA from different types of clinical specimens, requires minimal biosafety level precautions and, given its high sensitivity, can be easily adapted to pooling samples strategies. Using this simplified protocol, samples are eluted in TRIzol immediately after collection and RNA is extracted.

Results have shown that this protocol is as efficient, if not more than the CDC-approved silica-membrane based RNA purification microcolumns in isolating small amounts of viral and cellular RNA from multiple types of samples (nasal and throat swabs and saliva).

" The high sensitivity of our protocol may be useful in testing patients with low viral titers such as asymptomatic patients or testing individuals prior to quarantine release. Our method also enables several patient samples to be pooled, decreasing the number of tests required for larger populations. In addition, testing can easily be carried out by any research laboratory equipped with minimal standard equipment. Since saliva can be utilized as a reliable source of virus, samples can be self-obtained by patients and inactivated in TRIzol, eliminating the need for medical staff and higher-level biosafety protocols and facilities."

- Massimo Caputi, Ph.D., Lead Author and Professor of Biomedical Science, FAU's Schmidt College of Medicine

With this new approach, samples are first pooled and tested; positive pools are then retested individually. This relatively simple solution decreases the testing resources used but results in a loss in sensitivity from diluting positive patient samples with negative ones, hence the need of highly-sensitive tests that utilize biological materials, like saliva, which can be obtained in larger amounts and can be easily preserved for re-testing.

The protocol uses common chemical reagents that are in abundant supply and can isolate high-quality RNA that can be utilized for multiple assays and RNA sequencing projects. In addition, samples in TRIzol can be preserved at 4 C for more than a week with minimal degradation and little to no loss of viral RNA. Moreover, the ability to use saliva samples, which are as- or more sensitive and reliable than nasopharyngeal swabs, offers an attractive specimen alternative. Nose and throat swabs are the most common upper respiratory tract specimens used for COVID-19 diagnostic testing. However, the collection of these specimen types can cause discomfort, bleeding, and requires close contact between healthcare workers and patients, posing the risk of transmission.

In the most commonly used COVID-19 testing protocols, a healthcare provider collects a nasal or throat swab and transfers it to a vial containing a few milliliters of VTM. The sample is then transported to a laboratory for testing. The transport and storage can take from a few hours to a few days depending on the distance and processing times of the nearest clinical laboratory. The CDC recommends that specimens are stored at 2 to 8 C for up to 72 hours after collection and at -70 C or lower for longer periods of time. However, the logistics of having multiple sample collection points, chokeholds in the reagents supply chain, and abrupt increases in the demand for testing due to local outbreaks might generate unexpected delays in processing the samples.

"We can expect a high demand for COVID-19 testing in the foreseeable future as testing of the general population and asymptomatic individuals becomes more widespread," said Janet Robishaw, Ph.D., co-author, senior associate dean for research and chair of the Department of Biomedical Science in FAU's Schmidt College of Medicine. "The lack of control of the pandemic in many underdeveloped countries as well as the continued escalation of COVID-19 in the U.S. also are compelling reasons to increase testing efforts. We are hopeful that a combination of testing approaches, including protocols like ours, may be the most efficient way to fill the current and future gaps in testing."

Source:

Florida Atlantic University

Journal reference:

Paz, S., et al. (2020) A simplified SARS-CoV-2 detection protocol for research laboratories. PLOS ONE. doi.org/10.1371/journal.pone.0244271.
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