Saturday, February 29, 2020

Hygiena Launches BAX® System DNA Cleanup Kit that Eliminates Contaminant DNA and Allows for More Accurate PCR Detection

Hygiena, a global leader in rapid microbial detection, monitoring, and identification technology, introduced the BAX® System Free DNA Cleanup Kit, which degrades external contaminant target DNA, further reducing the possibility of false positive results during polymerase chain reaction (PCR) runs.

While PCR allows for precise identification of low levels of target DNA, one criticism of the technique is that it amplifies DNA from both live cells and “free” DNA released from dead cells.  “Free” DNA from dead cells can be present due to processing, cleaning, or bacteriophage preparations which are used to control pathogens.

The BAX® System Free DNA Cleanup Kit easily integrates with the BAX® System workflow and has been internally validated to degrade any “free” contaminating DNA. Hygiena scientists successfully demonstrated the use of the kit for degradation of “free” contaminant DNA from samples of bacteriophage solutions for Listeria and Salmonella.  The kit degrades very large amounts of target DNA (up to 400 ng). Most importantly, the kit does not interfere with intact DNA within living bacterial cells and their subsequent detection by PCR assays. Additional studies by a large poultry processing company and a prominent southeast Asia government agency resulted in similar results.

 “We’re delighted to announce this new addition to our product line, which will make PCR reactions more reliable, which is vital for securing a safe food supply,” said Martin Easter, Chief Scientific Officer of Hygiena. “The BAX System Free DNA Cleanup Kit more reliably degrades contaminating DNA, ensuring accurate results and providing the peace of mind that our customers have come to expect from Hygiena products.”

Interference from “free” DNA is generally not an issue when using the BAX® System because food or environmental samples are enriched prior to testing. Enrichment provides the nutrients for live bacterial growth; dead cells are not affected. Therefore, dead cells would need to be present at a sufficient level prior to enrichment to yield the concentration required for BAX® System detection (approximately 10,000 cells/ml).  However, certain product types and process conditions can result in the presence of contaminating extraneous “free” DNA leading to unconfirmable positive PCR results which impair the ability to make rapid, confident decisions on food safety.

WuXi Develops COVID-19 Epidemiological Investigation and Diagnosis Tests

WuXi Diagnostics has successfully developed a series of COVID-19 detection products, including 2019-nCoV IgM Detection kit (Enzyme-linked Immunoassay, ELISA), 2019-nCoV IgM/IgG Detection Kit (Enzyme-linked Immunoassay, ELISA) and 2019-nCoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method). All these products, as a set of "integrated detection" solution, assist medical institutions to diagnose COVID-19 infection quickly and accurately, and improve epidemic prevention and control capabilities for disease control centers at all levels.

Immunoglobulin antibodies appear after the 2019-nCoV infection and initiate an immune response. IgM antibody is an indicator of current infection and IgG antibody is an important indicator of recent and past infection.

WuXi Diagnostics 2019-nCoV IgM/IgG and IgM Detection Kits can specifically detect IgM and IgG antibodies of COVID-19, covering the entire course of infection and recovery period of patients. This integrated approach improves the overall diagnosis of COVID-19 in both acute and recovery phases of illness.

Our two serological kits utilize enzyme-linked immunoassays, and provide an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients. Our kits can detect COVID-19 specific IgM and IgG antibodies in serum samples within 60 minutes with high reproducibility. Both methods do not require expensive medical instruments and consumables, and offer a favorable solution in primary medical institutions compared to other detection methods.

Nucleic acid detection, a "gold standard" for the diagnosis of COVID-19

Nucleic acid testing is considered to be the "gold standard" for the diagnosis of COVID-19. WuXi Diagnostics 2019-nCoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) is based on the latest COVID-19 sequence variation studies. Our Kit utilizes fluorescence quantitative PCR combined with a TaqMan probe with high specificity to ensure accurate identification of ORF1ab and N genes of 2019-nCoV. The kit offers a highly sensitive test with a limit of detection as low as 1000 copies/ml. Our assay is optimized with an internal control to exclude false-negative results from sample inhibitors and amplification failures. The kit can be used for the detection of 2019-nCoV infection in different types of samples, such as nasopharyngeal swabs, alveolar lavage fluid, sputum, etc. Our assay can provide the result as soon as two hours from processing a sample.

Coupling serological testing with nucleic acid detection provides a high-quality, multi-dimensional and cost-effective diagnostic solution

Performing just one type of test to diagnose COVID-19 could lead to a false-negative result or misdiagnosis due to complex medical conditions of the patients. Therefore, implementation of a combined diagnostic workflow by integrating serological and molecular tests using the three 2019-nCoV viral detection kits developed by WuXi Diagnostics, will provide a comprehensive diagnosis for clinicians.

We are at a critical moment for prevention and control of the COVID-19 epidemic. WuXi Diagnostics' integrated solution, which combines both serology and molecular tests, can meet the detection needs for early disease prevention and control, differential diagnosis, and epidemiological investigations. Our kits provide a high-quality, multi-dimensional and cost-effective solution for disease control departments and medical institutions.

"WuXi Diagnostics is devoting every effort with all healthcare providers to building a reliable line of defense against COVID-19", says Jason Liu, Ph.D., Chief Executive Officer of WuXi Diagnostics. "We will leverage advanced technology, continuously launch high-quality diagnostic solutions, and contribute in winning this battle against of COVID-19."

Cepheid and Sherlock Biosciences Establish Collaboration on New GeneXpert Tests for Infectious Diseases Leveraging CRISPR Technology

Cepheid and Sherlock Biosciences today announced a research collaboration between the two companies to explore the development of new cutting-edge molecular diagnostic tests. Leveraging Sherlock Biosciences' engineering biology platform, SHERLOCK™, a CRISPR-based technology that can identify virtually any genetic target, new tests could be designed to run on Cepheid's GeneXpert® Systems. The collaboration will focus on molecular diagnostic tests for infectious diseases and oncology, beginning with a proof-of-concept project focused on detection of coronavirus (SARS-CoV-2).

"This partnership will allow us to explore utilizing Cepheid's easy-to use-cartridge to further develop targeted molecular tests that better address outbreak scenarios," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "With a global installed base of over 23,000 GeneXpert Systems, this technology could potentially be applied in multiple settings where actionable treatment information is needed quickly."

The companies plan to jointly pursue grant opportunities to further push development of newer molecular diagnostic tests to allow future GeneXpert users access to expanded test menu and capabilities. The companies may pursue opportunities in infectious diseases and oncology, including exploring how better to address outbreak scenarios.

"SHERLOCK is an ideal platform for rapid response and development for any global outbreak, while also a powerful tool for affordable and rapid molecular diagnostic testing for routine assays," said Rahul Dhanda, Sherlock's Co-Founder, President and Chief Executive Officer. "We are excited to work on bringing our breakthrough CRISPR technology to Cepheid's revolutionary GeneXpert platform, which should enable our companies to provide potential diagnostic solutions for a range of applications including infectious diseases and oncology. Initially, we will explore the compatibility of our technologies for coronavirus detection, while pursuing a broad set of solutions that enable users to make more effective decisions in both clinical and non-clinical settings worldwide."

Friday, February 28, 2020

Taiwan Developing 10-minute COVID-19 Test Using SARS Antibodies

Taiwan's National Health Research Institutes (NHRI) is planning on using SARS antibodies to develop a rapid test to detect the Wuhan coronavirus in just around 10 minutes.

Huey-Kang Sytwu (司徒惠康), vice president of the NHRI, was cited by the Liberty Times as saying that at present, the principle behind developing a rapid screening reagent is to detect the virus using antibodies, such as the case with influenza. He said this generally involves taking a swab from the nose, placing it in a vial containing viral transport media, and dripping the contents into the sample well for testing.

These sorts of tests generally take 10 to 15 minutes to yield a result and have an accuracy level of about 50 to 60 percent. Sytwu said that in 2003, the NHRI and the National Defense Medical Center used the SARS virus to produce antibodies in mice.

Recently, it was found that the antibodies to SARS have the same antigens as COVID-19. Scientists at the NHRI believe that SARS antibodies could be used to develop a new COVID-19 rapid screening test.

An application for use of the SARS virus for research was submitted to the Taiwan Centers for Disease Control (CDC) two or three weeks ago, and it is expected that the virus will be sent to the NHRI for testing in the near future.

Sytwu said that the preliminary results are expected within two or three weeks. If it is found that the SARS antibodies can detect COVID-19, it is expected that it will enable rapid screening for clinical examination and verification.

Sytwu cautioned that approval for the rapid test from the Food and Drug Administration (FDA) will take some time. He said it is difficult to estimate how long approval will take, but that "it should not take too long," according to the report.

Health Minister and Central Epidemic Command Center (CECC) Head Chen Shih-chung (陳時中) said that it currently takes nearly an entire day to yield the results of a COVID-19 test. According to Sytwu, testing for the virus currently takes a lot of time and effort; if a quick test can be successfully be developed, it will expedite the treatment process.

Israeli Biomed Firm Says It Developed New Diagnostics Kit For Coronavirus With Results In 25 Minutes

Israel’s BATM Advanced, a provider of real-time tech for networking solutions and medical laboratory systems, announced on Thursday that it developed a quick and accurate diagnostics kit for the novel coronavirus, known as 2019-nCoV. The virus causes the disease called COVID-19 which has, as of February 26, claimed the lives of over 2,800 people, mainly in mainland China, and infected over 82,000 worldwide (according to this live-updating map of the outbreak that draws figures from the World Health Organization and other agencies).

BATM Advanced said the kit, developed by its bio-medical division, will allow laboratories to detect whether a patient has the virus in approximately 25 minutes. The kit has undergone testing by several central laboratories and hospitals, and BATM said it will begin production of the kit at the company’s Adaltis facility in Rome.

The company said it is working with academic and research institutions, primarily in Europe, to make the kit affordable for large-scale production. BATM said laboratory bench tests will begin as soon as possible.

BATM’s CEO Dr. Zvi Marom tells NoCamels that the biomed firm received a sequence of the virus, and subsequently the virus itself, for testing purposes. Dr. Marom says the company already has an advanced diagnostics kit that can detect SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome) “and COVID-19 is a related disease so the idea is to have the kit be able to differentiate between them.”

Dr. Marom says BATM has been in touch with colleagues in China and other countries from the beginning of the outbreak, trying to learn as much as possible about the virus to develop a diagnostic solution.

BATM said the COVID-19 diagnosis system will also be included in a suite of testing kits for travel panels developed by its subsidiary Ador Diagnostics, which is focused on the development of unique in-vitro molecular diagnostics. Ador developed a molecular biology solution called NATLab that provides rapid diagnosis of bacterial, viral or fungal infections within approximately 15-90 minutes, using DNA sampling. NATLab received its first commercial order in January.

“NATLab has 40 registered patents and tests for tropical diseases like malaria and tuberculosis, infections like streptococcus [strep throat] and sepsis, and also meningitis, so now with COVID-19 added, labs can know who has what in about 25 minutes,” Dr. Marom tells NoCamels.

“We believe that the strategy we adopted in our bio-medical division is proving to be correct, especially in light of the current COVID-19 outbreak,” Dr. Marom said earlier in a press statement. “We are able now to quickly provide diagnostic kits for any new pathogen that appears.

“Furthermore, we have already received extremely positive feedback and significant interest from several leading medical institutions that have started testing the first panel of Ador’s NATlab solution and adding COVID-19 will greatly strengthen its appeal and value,” he added.

BATM said the COVID-19 kit supports all the US Centers for Disease Control and Prevention (CDC) recommendations and has already received interest from customers in several countries.

Dr. Marom tells NoCamels that once the spread of the virus stops – he suggested around Passover time in April – “we will have a better idea of how to quickly diagnose for the next time.”

Thursday, February 27, 2020

Anitoa Introduces Rapid, On-site Nucleic Acid Test for COVID-19

Anitoa Systems, a Silicon Valley biotech company has demonstrated a solution for rapid on-site nucleic acid test of the 2019 novel coronavirus (2019-nCoV). Anitoa combines a high performance ultra-portable Real Time Polymerase Chain Reaction (qPCR) instrument called Maverick, with an innovative "one-step" reverse transcription qPCR (RT-qPCR) reagent for testing 2019-nCoV. This solution eliminates the cumbersome process of package and transporting patient samples to a central lab and the additional steps of tedious sample-prep prior to running RT-PCR. This saves time and reduces risks of cross-contamination. Moreover, Anitoa's solution is more accurate, as it avoids false-negative readings due to the degradation of viral RNAs in the sample when transported.

Since the outbreak of the 2019-nCoV in China at the turn of the New Year, thousands of lives have been lost and many more are negatively impacted. Since there is a 2-3% death rate from this virus and it may be transmitted by exposed individuals who show no symptoms, an effective screening test for the virus is vital for controlling this outbreak.

With Anitoa's solution, patient samples, such as throat or nasal swaps, can be applied directly to the portable instrument on-site without the need to freeze, transport and thaw the samples. The Maverick RT-qPCR device has a sophisticated 4-plex optical multiplexing subsystem to detect multiple gene targets in one sample, and it take about 30 minutes from sample to results.  Maverick is powered by a unique CMOS biosensor chip developed by Anitoa. The CMOS biosensor integrates many sensing and processing functions necessary for qPCR in a single silicon chip, thus significantly reducing the footprint and cost of the device.

Having a R&D center in Hangzhou China, Anitoa tested its solution in hospitals and CDC-labs of China with actual patient samples. Early test results with Maverick solution showed a 97% accuracy, with 99% specificity.

"We are encouraged by the very promising performance results of the Maverick solution in detecting the 2019 new coronavirus. We want to contribute everything we have to help fight and prevent the spread of this terrible and deadly disease," says Dr. Zhimin Ding, CEO of Anitoa Systems.

The Anitoa Maverick instrument and test kit is provided as a turn-key solution for detecting 2019-nCoV. Anitoa is in the process of applying for clinical clearance under emergency use authorization (EuA) regulations in both USA and China.

Mologic, Institut Pasteur de Dakar to Develop Ebola Rapid Diagnostic Test

Mologic said Tuesday that it has launched an accelerated program with the Institut Pasteur de Dakar to develop a low-cost, high-performance rapid diagnostic test for Ebola virus disease.

Bedfordshire, UK-based Mologic said that it will apply ultra-sensitive lateral flow technology developed at its Centre for Advanced Rapid Diagnostics and lead product development and manufacturing. Senegal-based Institut Pasteur de Dakar will lead test validation in collaboration with the Institut National de Recherche en Biologie (INRB) in Kinshasa, Democratic Republic of the Congo (DRC). The collaborators anticipate manufacturing the test in the UK and in Senegal at the Institut Pasteur de Dakar.

Mologic and Institut Pasteur de Dakar staff are currently validating three rapid diagnostic test prototypes prior to initiating a trial with INRB in the DRC during March 2020.

The new test is being developed to detect the Ebola infection early in blood by embedding monoclonal antibodies against surface glycoproteins. The project is building on development work by BIOASTER, the French Technology Research Institute, during the West Africa outbreak from 2014 to 2016, Mologic said.

BIOASTER has developed six mouse-derived monoclonal antibodies to the surface glycoproteins of the Ebola virus that have been shown to have high performance in a clinical evaluation involving human infected samples. A surface glycoprotein-targeted detection prototype showed better diagnostic performance than commercially available rapid diagnostic tests using viral culture supernatants and infected monkey plasmas, said Mologic, citing a clinical study.

Early detection of a confirmed Ebola case is a major challenge that can be a bottleneck to initiating an effective public-health response and preventing its transmission to urban centers in DRC and internationally, Mologic said. The disease has overlapping symptoms with other endemic diseases, making an accurate diagnosis even more challenging.

"With support from the Gates Foundation, since 2016, Mologic has deepened its focus on epidemics and neglected diseases," the firm's Medical Director Joe Fitchett said in a statement.

The new project aims to overcome obstacles associated with case identification, logistics, and sample transportation to a central qualified lab, by developing a simple test deployed at the point of need, Mologic said.

The test has potential to significantly improve response times and control of the epidemic through time-critical contact tracing, community engagement, immunization, and safe and dignified burial, the firm added.

LexaGene’s LX Analyzer Successfully Detects Coronavirus RNA Using the CDC’s Tests

LexaGene, a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers, announced today the successful adaptation of the Centers for Disease Control and Prevention (CDC) Coronavirus Diagnostic Panel1 to their LX technology platform.

The COVID-19 outbreak (formally called 2019-nCoV) is the most lethal coronavirus outbreak so far, surpassing the 2002 SARS2 and 2012 MERS3 outbreaks. As of February 19, 2020, more than 75,000 cases and 2,000 deaths were reported worldwide.4  This illness has been reported in 25 countries and been declared by the World Health Organization as a “public health emergency of international concern.”5

Dr. Jack Regan, LexaGene’s CEO and Founder states, “The world needs easy-to-use fully automated pathogen detection instruments operating at points-of-need that can be equipped with tests to detect a novel pathogen within a week of knowing its genetic sequence.  For this outbreak – the lack of such technology forced all testing to occur in distant reference laboratories, making rapid decisions on quarantine impossible and making the likelihood of successful containment remote.  This shortcoming has arguably cost hundreds of lives to date.  LexaGene expects to be the first company to commercialize an automated open-access microfluidic technology designed for use at the point-of-need that can be configured to detect a novel pathogen in just a week’s time of its emergence – for use on-site to return results in one hour – and improve our chances of successful containment.”

One of the hallmarks of LexaGene’s LX Analyzer technology is its open-access feature that allows users to very quickly introduce newly developed assays into the platform for fully automated and rapid detection of novel pathogens. To demonstrate this, LexaGene’s scientists adapted the CDC Coronavirus Diagnostic Panel to the LX Analyzer platform.  The CDC panel is comprised of three tests for SARS-CoV-2, the pathogen that causes COVID-19. This CDC panel has been granted Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA).6

Using LexaGene’s automated LX Analyzer equipped with the adapted CDC Coronavirus Diagnostic Panel, the Company successfully detected the presence of the SARS-CoV-2 N-gene RNA in contrived respiratory samples, whereas the severe acute respiratory syndrome (SARS) coronavirus RNA and Middle East respiratory syndrome (MERS) coronavirus RNA tested negative, as expected. In addition, the virions of the unrelated seasonal common cold virus, the human coronavirus OC43 (ZeptoMetrix7) was successfully detected by a specific assay, but tested negative with the CDC Panel, as expected.

Dr. Jack Regan continued, “I’ve spent my career working on improving infectious disease diagnostics.  LexaGene’s rapid pathogen detection instrument is needed in our fight against the COVID-19 epidemic.  Our successful adaptation of the COVID-19 Diagnostic Panel onto the LX platform, not only demonstrates the platform’s open-access capability, but also signifies our expansion into including respiratory pathogens as part of our menu as we prepare for commercial launch later this year.”

In addition, on February 19, the board of directors and compensation committee approved inducement grants in accordance with the Company’s Omnibus Incentive Plan for insiders totaling 1,285,000 restricted share units (“RSUs”) and 320,000 Options.  Each Option is exercisable into one common share of the Company (“Share”) at a price of $0.72 per Share, for a period of ten years from the date of grant. The RSUs and options will vest 25% starting on 02/19/2022 and then 25% every four months thereafter.  The RSUs will have an expiry date of 02/19/2023.

Luminex Submits VERIGENE II Respiratory Flex Assay for FDA Clearance

Luminex Corporation announced that the company has submitted an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the VERIGENE® II Respiratory Flex Assay, the second VERIGENE II assay to be submitted to the agency. The VERIGENE® II Respiratory Flex (RSP Flex) Assay is a multiplexed, qualitative test for simultaneous detection and identification of common viruses and bacteria from nasopharyngeal swabs that are obtained from individuals suspected of respiratory tract infection.

This assay, along with the Gastrointestinal (GI) Flex Assay, both run on Luminex's new VERIGENE II system. The GI Flex Assay is an automated test for the detection and identification of enteric bacteria, viruses, parasites, and toxins in stool samples. Both are now under review with the FDA, and Luminex anticipates launching the new VERIGENE II assays mid-year.

"We are delivering on our strategy and our promise to expand the menu of clinically relevant, high-value tests that accelerate and simplify diagnostic testing," said Homi Shamir, President and CEO of Luminex. "We're also demonstrating once again the cost-effectiveness of rapid testing on a Luminex platform. The flexibility of the automated VERIGENE II System uniquely allows clinical laboratories to select, test and pay for only the targets ordered for each patient. This is a game-changer for many laboratories."

The VERIGENE II System is a benchtop molecular diagnostic system that uses advanced automation and specialized chemistry to enable rapid, sample-to-result detection. The RSP Flex Test is performed on this system utilizing reverse transcription, polymerase chain reaction, and array hybridization to detect specific respiratory viral and bacterial pathogen nucleic-acid gene sequences.

"By expanding the foundational assays on our next-generation VERIGENE system to a wider variety of common viruses and bacteria, we are helping laboratories deliver fast, accurate results and are streamlining the process of sample testing," said Shamir.

When targeted therapies depend on clinical test results, testing of nasopharyngeal samples for specific pathogens is highly useful, especially given that respiratory tract infections (RTIs) are among the three most common acute illnesses evaluated in outpatient care.1 Children are particularly vulnerable to RTIs, with an average of six per year.2 If these illnesses are not diagnosed accurately or quickly enough, they can lead to more serious illness and, in severe cases, to increased childhood mortality. The VERIGENE II RSP Flex Assay delivers a critical test that is designed to address this widespread and costly challenge.

Tulane Researchers Developing Rapid Test for Tuberculosis

Led by Tony Hu, the Weatherhead Presidential Chair in Biotechnology Innovation at Tulane University School of Medicine, researchers at Tulane, Baylor College of Medicine and NanoPin Technologies, Inc. are now developing a rapid, reliable and highly specific test to allow rapid diagnosis of all forms of  Tuberculosis (TB), the leading worldwide cause of death from infectious disease.

More than 10 million people contract TB each year, and the disease kills 1.7 million people annually.  Efforts to control the global TB epidemic have had limited success, due to failure to identify and treat a majority of the individuals with active TB disease and partly because of the relatively poor ability of current diagnostic tests to recognize certain TB disease manifestations.

This research effort is being funded with a $3.8 million grant from the U.S. Army Medical Research Acquisition Activity office through the Peer Reviewed Medical Research Program in the Department of Defense to address health threats to military men and women deployed to overseas battlefields and on humanitarian missions.

Bacterial culture is still commonly used to diagnose TB and to identify drug-resistant TB cases in much of the world. However, bacterial culture tests can take several weeks to provide a final result and are unable to detect a substantial fraction of individuals with active TB disease, delaying the decision to start and end anti-TB treatments.

More recently developed molecular tests can reduce the time required for TB diagnosis, but also exhibit poor ability to detect certain manifestations of TB disease and are not useful in monitoring patient responses to anti-TB therapy.

“Our test has several advantages over currently existing TB tests, including the gold-standard of bacterial culture,” says Dr. Hu. “It requires only a small blood sample and directly measures TB-derived proteins to detect all forms of TB disease, including those missed by most other available TB tests. Notably, this approach can discriminate TB cases from those caused by related pathogens that produce similar symptoms but require different treatments.”

Dr. Hu’s test also indicates the severity of the infection and its response to treatment, using a streamlined approach suitable for high-throughput operation in clinical settings. This test uses equipment already approved by the FDA for other assays but can also be run on portable instruments suitable for use in resource-limited or extreme settings encountered during military and humanitarian missions.

Dr Hu’s team has performed multiple pre-clinical studies with this method and is now partnering with researchers at Baylor and NanoPin Technologies, Inc. to screen the diagnostic performance of this test in a large population of patients with and without active TB using both FDA-approved equipment and a new portable system, and develop an optimized test kit suitable for regulatory approval.

“The company will standardize the production pipeline,” says Dr. Hu. “This will be highly translational if we’re successful.”

The U.S. Army Medical Research Acquisition Activity, 839 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by the The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense through the FY18 Peer Reviewed Medical Research Program/Technology/Therapeutic Development Research Award under Award No. W81XWH18PRMRPTTDA. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. In the conduct of research involving hazardous organisms or toxins, the investigators adhere to the CDC-NIH Guide for Biosafety in Microbiological and Biomedical Laboratories.

Source: Tulane University News

Novacyt Launches CE-IVD Marked Novel Coronavirus Diagnostics Test

Novacyt an international specialist in clinical diagnostics recently announced that its molecular diagnostics division, Primerdesign, has launched its CE-Mark molecular test for the clinical detection of the novel coronavirus (COVID-19). The Directors believe that Primerdesign's COVID-19 test is the first CE-Mark test for 2019 the strain of novel coronavirus and follows the Company's rapid launch of its research use only (RUO) coronavirus test on 31 January 2020. As a result of the CE-Mark, the Company's COVID-19 test can be used directly by laboratories and hospitals for the testing of patients without the need for validation by clinicians. The Company anticipates increased demand for its test for COVID-19 due to this extended use for clinical diagnosis.

Primerdesign has already received requests for quotations for 288,000 CE-Mark tests since they were made available to pre-order on 14 February 2020. The Company has received orders for 40,000 RUO tests and requests for quotations for an additional 35,000 RUO tests prior to the launch of the COVID-19 clinical version. Demand for the tests has come from China, the US and the UK, as well as many other countries around the world.

The Company continues to see a high conversion rate from quotations to orders. However, it is difficult to predict how demand for the test will grow as the epidemic is still in its early stages. Since the initial reports of COVID-19, the Company has invested in manufacturing capacity to meet the current and potential future demand for its tests. The Primerdesign test is being formally evaluated by public health authorities from five countries and the Company is in discussions with these organisations to potentially support their national screening requirements for COVID-19.

The Company has submitted an application to and remains in discussion with, the US Food and Drug Administration (FDA) for Emergency Use Approval (EUA) of its test for COVID-19, which would allow laboratories in the US to use the test for clinical diagnosis on a temporary basis. The data generated from the CE-Mark approval will be used to support this application.

Source: Medical Dialogues

German Researchers Developing Rapid Salmonella Detection Test

Fraunhofer researchers are helping to develop a test to detect Salmonella in less than eight hours.

A team from the Fraunhofer Institute for Cell Therapy and Immunology, Branch Bioanalytics and Bioprocesses are working with the German microbiology and food analysis laboratory Selektis GmbH as part of a ProFIT project running from 2018 to 2020.

Core technology of the detection system is DNA-based amplification. Project partners have reduced the enrichment process from 18 hours to between four and six hours.

The user knows if a sample is positive for Salmonella as there is a yes or no answer without quantification on a digital display with a limit of detection in accordance with ISO 6579. It’s compatible for all food samples and could be adapted to environmental samples.

Timely enrichment

Traditional microbiological techniques can take up to four days, which is a problem for some food manufacturers who don’t want to wait that long for results before shipping goods. If a problem is then found the company may have to make a costly product recall.

Enrichment involves cultivating and propagating microbes, which are available only in limited quantities, in a liquid culture medium overnight, so there is a sufficiently high bacterial count for detection. This process lasts about 18 hours, with three days needed for the selective enrichment and incubation of the salmonellae in additional liquid media, for streaking of a bacterial culture on agar plates, and for the serological test.

It is important to get a high concentration of Salmonella DNA in a short timeframe for sensitive detection. The researchers use fluorescent dyes to label the replicated DNA and detect it using capture molecules. Although molecular biological detection techniques are already in laboratories, they are rarely used in fully automated processes and not in food diagnostics.

Dr. Harald Peter said they have created a rapid culture with growth conditions optimized for Salmonella.

“By means of an innovative, optimized enrichment method, we are able to increase the concentration of the bacteria to such an extent that we can detect them using molecular biological methods after only a few hours,” he said.

“To do this, the DNA of the salmonellae is amplified and automatically detected, something we achieve by extracting the DNA of the salmonellae and amplifying them by molecular biological means to such an extent that they can be detected after a further 30 minutes. For the rapid test, we design the molecules that specifically detect the DNA of the salmonellae.”

Role of automation

Peter and his team plan to develop a system that automatically performs procedures that are done manually, such as cultivation, enrichment, molecular biological replication and detection.

Currently five samples can be tested at once but this could be adapted to 100. The test is based on viable cells only.

All components will be integrated in a compact device. Using special molecular biological techniques, researchers at Fraunhofer IZI-BB can skip certain DNA purification steps to simplify and speed up the process.

The focus is on strains relevant for food monitoring but the assay can be modified to other strains and species if capture molecules are adapted to other organisms using a computer and gene databases.

“The German Food Hygiene Act stipulates that a sample of 25 grams of meat must not contain a single Salmonella bacterium. Consequently, the new rapid test has to be capable of detecting a single bacterium within six to eight hours – that is, within an average working day. A further task is to distinguish the salmonellae from other microorganisms,” said Peter.

Business promotion banks for the federal states of Brandenburg and Berlin are sponsoring the project with funding from the European Regional Development Fund (ERDF).

Covaris Launches Novel Viral RNA Extraction Kits for Swab Collection Devices Including Those Used for COVID-19 Detection

Covaris, Inc. announced the release of two new kits for viral RNA extraction from nasal or throat swab sample collection devices. The first is the truXTRAC® Viral RNA Extraction kit using Puritan® Swabs, which contains all components for AFA-enhanced extraction and magnetic bead-based purification of high-quality RNA from synthetic swabs for downstream analysis. The second is the truXTRAC-PCR Direct Viral RNA Extraction kit, which can be used directly in real time RT-PCR assays without prior purification, provided an internal control is included.  Covaris is currently working with a Chinese customer to evaluate these novel active extraction kits for use with assays for the COVID-19 virus.

In the containment of a potential epidemic, accurate diagnostics are critical for the foundation of the epidemiologic studies used by authorities to decide on the best course of action. A failed QC process or false negative result for the COVID-19 virus does not necessarily indicate that the analytical technology was inaccurate. Advanced analysis cannot compensate for a sample that was poorly extracted and incompletely prepared. For example, both real time RT-PCR for rapid detection and/or high-throughput sequencing for metagenomic studies require effective pre-analytical sample preparation. Jim Laugharn, Founder and CEO of Covaris commented, "Robust and efficient sample preparation is the key to reducing false negative results when processing difficult input biological samples such as swab specimens. Our goal is to standardize and simplify workflows using active acoustic processing."

Covaris Adaptive Focused Acoustics® (AFA®) is a proven technology for active extraction of labile, low frequency biomolecules from complex, difficult biological samples. Utilization of Covaris AFA-technology in conjunction with Covaris lysis and purification reagents greatly enhances recovery of nucleic acids from high surface areas, such as CDC-recommended synthetic swab tips, as compared to passive extraction methods (e.g., vortexing etc.). In addition, Covaris has demonstrated equivalent recovery of viral nucleic acids from dry-stabilized whole blood on swabs, as compared to fresh blood.  

Covaris is actively supporting customers, organizations, and government agencies in their development of robust and accurate detection assays.

Saturday, February 15, 2020

Vietnam Announces 70-Minute Rapid COVID-19 Test Based on RT-LAMP

Good news has come as Vietnamese scientists have successfully created a toolkit to quickly detect the 2019 novel coronavirus (2019-nCoV) within just 70 minutes, instead of the three hours needed for other usual test methods.

The collaboration between the School of Biotechnology and Food Technology (SBFT) under the Hanoi University of Science and Technology and Innogenex International Science and Technology Co. Ltd. has resulted in the achievement.

In efforts to deal with the spread of nCoV epidemic, the research team, led by Dr. Le Quang Hoa, and Innogenex have announced the latest result in forming the quick test kit based on RT-LAMP (Reverse Transcription-Loop-Mediated Isothermal Amplification) technology, a nucleic acid isothermal amplification technique specifically used to detect the RNA of pathogenic viruses.

With the newly-formed test kit, it is known that Vietnam is the first country to successfully produce the RT-LAMP quick test kit for detecting the 2019-nCoV, which helps to shorten testing time and simplify the analytical process, that is applicable right from at district-level hospitals.

A study within less than a month

Previously, to test the suspected nCoV cases, Vietnam applied a gene sequencing test method that took 3-5 days. Then, with the World Health Organisation (WHO) test sample combined with molecular biology testing method, the time for needed to test for the new coronavirus in Vietnam decreased to less than 9 hours. In the world, the standard real-time polymerase chain reaction (real-time PCR) method recommended by the WHO takes about 3 hours to get results.

Sharing with Nhan Dan Newspaper, Dr. Le Quang Hoa, Head of the SBFT’s Gene Technology Laboratory, said his 10-member team had started a study on rapid detection of nCoV from January 15, right after China announced the genome sequence of the new strain of coronavirus.

Right before the Lunar New Year (in late January), the team designed the primers of the colour-changing RT-LAMP reaction to detect viral RNA specificity and completed the synthesis of artificial genes for the genetic material of this pathogen.

Over the last 10 days, the research team completed the process of producing their biological product to ensure sensitivity and specificity equivalent to the standard real-time PCR method which is recommended by WHO.

Detecting positive nCoV cases in only 15-30 mins

Dr. Hoa said that the principle of RT-LAMP method applied by the group is nucleic acid isothermal amplification technique, in which the reverse transcription and amplification phase are performed at a single temperature, with amplification of DNA up to over a billion times. In particular, a positive reaction is detected directly based on the discoloration of the solution, which helps to shorten and simplify the analysis process. The total analysis time is only 70 minutes, which consists of two stages: RNA extraction of the virus (30 minutes), and preparation and conducting RT-LAMP reaction (40 minutes).

“RT-LAMP reaction only needs 30 minutes to conclude whether the sample is positive for RNA of 2019-nCoV or not. For strong positive samples, they can be detected only within 15 minutes,” said Dr. Hoa.

Another outstanding advantage of the RT-LAMP bio-product over the standard real-time PCR is its simplicity, with no complicated equipment required. This helps in that the RT-LAMP test kit can be used right from in district hospitals and field hospitals when there is an outbreak, thus localising the epidemic and limiting its spread.

In particular, the production cost for the new test kit is only at VND350,000 (over US$15), while the production cost of the real-time PCR test kit is VND1 million. Compared to other molecular biology techniques, the RT-LAMP requires simple devices with only a thermostatic tank for on-site application, while the kit is also highly sensitive and specific, equivalent to the real-time PCR one.

Hoa added that due to the lack of access to real patient samples, the team has not yet determined the accuracy of their kit on clinical specimens. However, when it is performed on faked samples using artificial synthetic RNA, the results obtained were accurate.

“We hope that the Ministries of Health and Science and Technology to support the research team so that we can test the kit and determine its exact ratio in the near future to serve the epidemic control right from the district hospitals,” Hoa said.

His team is seeking to coordinate with specialised units of the Ministry of Health to conduct the inspection as well as to make contact with businesses to transfer technology to produce the biological product.

On a laboratory scale, the team can produce about 2,000 test kits per day. In the next two weeks, the kit is expected to be applied in practice after being thoroughly tested.

Source: Nhân Dân

PolyU Develops an Automated Multiplex Diagnostic Test for Detecting up to 40 Infectious Respiratory Pathogens Including 2019-nCoV (COVID-19)

Infectious diseases represent an important portion of global public health concerns¸ in particular with regard to the current global outbreak of novel coronavirus (2019-nCoV). The challenge of frontline diagnosis in hospitals, clinics and ports is that infectious diseases could exhibit similar symptoms or can be asymptomatic. The Hong Kong Polytechnic University (PolyU) today announced the development of the world's most comprehensive automated multiplex diagnostic system (the System) which includes a fully automated machine and a multiplex full-screening panel for the point-of-care genetic testing (POCT) of respiratory infectious disease including the 2019-nCoV.

In one single test and within approximately one hour, the System can identify 30 to 40 pathogens including seasonal influenza viruses, such as influenza A subtypes H1, H2 and H3; avian influenza viruses H5, H7 and H9; human respiratory syncytial virus; severe acute respiratory syndrome coronavirus (SARS-CoV); Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019-nCoV. Leveraging the current polymerase chain reaction (PCR) technology, the system is fully automated from sample nucleic acid extraction and amplification, to signal detection and analysis. The System adopts patent-pending microfluidic and biochemical technologies that achieve ultra-sensitive detection (down to 5 gene copies) and simultaneous differentiation of various pathogens with extremely high specificity. It is also user-friendly, with manual handling not being required throughout the testing process.

"Early and accurate detection of pathogens could contribute to effective and efficient disease control and management, and prevent spreading of any contagious pathogens. It benefits the patients as well because timely therapy can then be applied to prevent complications. The existing challenge is that we lack full panel POCT technologies for early and on-site diagnosis, which should ideally be capable of differentiating between different pathogens at the same time. This newly-developed system could be a practical solution," said Professor Lau.

PolyU and The University of Hong Kong (HKU) have established the Respiratory Virus Research Foundation ("the Foundation") in 2015 and have since then been working on various innovative technologies to tackle existing and emerging respiratory infectious diseases. The Foundation has fostered various collaborations, including those on vaccine and rapid diagnostics respectively. The former is led by HKU Professor Yuen Kwok-yung, Henry Fok Professor in Infectious Diseases, Chair Professor of Infectious Diseases from the Department of Microbiology, Li Ka Shing Faculty of Medicine; the latter is led by PolyU Professor Terence Lau Lok-ting, Director of Innovation and Technology Development and Adjunct Professor at the Department of Applied Biology and Chemical Technology.

Ir. Professor Alexander Wai Ping-kong, Vice President (Research Development), Deputy President and Provost designate of PolyU, said, "In this difficult and challenging time that Hong Kong, the Chinese mainland, and even the global community is encountering, it is important that the research community can quickly pool their expertise and resources to develop practical solutions. The PolyU-HKU partnership is a prime example of effective coupling of multidisciplinary innovation and translation."

The research team for this project is led by PolyU Professor Terence Lau Lok-ting and supported by HKU Professor Yuen Kwok-yung. Through collaborative efforts, the team has spent the past four years to develop the System. In the past year, the team has optimised  the System and conducted trials on different clinical samples. In the midst of the 2019-nCoV outbreak, the team has also conducted tests on clinical samples using the system.

Professor Yuen commented, "The System's versatility and capability will provide for comprehensive monitoring during disease outbreaks or routine surveillance. It will become a crucial technology for ensuring the effective control of infectious diseases, medical diagnosis, and treatment."

"This fully automated, quantitative rapid diagnostic platform possesses a proprietary technology which overcomes limitations of existing technologies by ensuring sensitivity -- and hence significantly enhancing the reliability of test results. Most importantly, our innovation can substantially reduce the cost of the microfluidic cartridge manufacturing thus making it feasible for wide adoption. It is ready for mass-scale production," added Professor Lau.

The research team has received indispensable support from a local biotechnology company Avalon Biomedical Management Ltd for this project.  "We are honoured to be able to participate in this project and are delighted to see this important milestone in the collaboration between Professor Lau and Professor Yuen. We believe this advanced point-of-care diagnostic system can revolutionize the current diagnostic paradigm and provide a powerful tool to fight against infectious diseases," said Dr Manson Fok, Chairman of the Board of the company, Executive & Trust Committee member of Macau Henry Fok Foundation and Dean of Faculty of Medicine, Macau University of Science and Technology.

Humankind's modern day battles against epidemics remain a major challenge and it is vital that people keep learning from the past and equipping themselves with the best technologies available. Towards this end the research team will continue to urgently focus on developments to ensure the system's robustness and cost-effectiveness, and to collaborate with relevant parties on clinical trials, regulatory approvals, and frontline applications of this POCT system.

SOURCE Hong Kong Polytechnic University

CDC Concludes Some Coronavirus Test Kits Are Flawed

Some of the coronavirus testing kits sent to state laboratories around the country have flaws and do not work properly, the Centers for Disease Control and Prevention (CDC) said on Wednesday.

The kits were meant to enable states to conduct their own testing and have results faster than they would by shipping samples to the CDC in Atlanta. But the failure of the kits means that states that encountered problems with the test should not use it, and would still have to depend on the CDC’s central lab, which could cause several days’ delay in getting results.

“Obviously, a state wouldn’t want to be doing this test and using it to make clinical decisions if it isn’t working as well, as perfectly, at the state as it is at CDC,” Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, said at a news conference on Wednesday.

The CDC recommends testing for some people who have symptoms like fever, cough or shortness of breath, and who, within the past 14 days, have traveled to China or have been in close contact with a patient known to be infected with the coronavirus. Doctors with patients in that category are supposed to consult their state health department about whether the patients should be tested for the virus.

The CDC announced late Wednesday that another evacuee quarantined at a military base in California had tested positive for coronavirus. The new case among evacuees from Wuhan, the epicenter of the outbreak, brings to 14 the total of confirmed cases in the United States. A previous case was diagnosed at the Miramar base in San Diego on Sunday.

The first and second patients arrived on different planes and were housed in separate facilities at Miramar, according to the CDC Dr. Chris Braden, an expert on the site, said in a statement that, “At this time there is no indication of person-to-person spread of this virus at the quarantine facility, but CDC will carry out a thorough contact investigation as part of its current response strategy to detect and contain any cases of infection with this virus.”

The CDC announced last week that it had begun shipping about 200 kits to laboratories in the United States and roughly 200 more to labs in more than 30 other countries. Each kit can test about 700 to 800 specimens from patients, the agency said.

Kits were shipped to every state, but officials did not say how many of the kits were faulty.

At a news conference on Wednesday morning, Dr. Messonnier said that test kits had been shipped to more than 30 other countries, but later in the day said that she was mistaken, and that the international shipments had been held back because of the flaw.

Before the kits were shipped to the states, Dr. Messonnier had emphasized repeatedly at news conferences that the kits would not go out until the CDC was sure they were as accurate as possible.

Dr. Jeanne Marrazzo, director of the infectious diseases division at the University of Alabama at Birmingham, said accurate diagnostic tests were invaluable.

“The test is the only way you can definitely know you have the infection,” Dr. Marrazzo said. “You absolutely need it for case counting. It allows you to know who’s infected. You can treat those people, if a treatment is available, and you can isolate them.”

Doctors in China said there was an urgent need for a simpler, quicker diagnostic test, officials from the World Health Organization said during a news briefing on Wednesday.

On trial runs in some states, the CDC kits produced results that were “inconclusive,” Dr. Messonnier said. The tests did not involve samples from potential patients, but were part of the routine quality-control procedures that labs go through before using a test to make real diagnoses.

“Things may not always go as smoothly as we may like,” Dr. Messonnier said.

The problem appeared to come from one ingredient involved in the test, Dr. Messonnier said, adding that the CDC would make a new supply of that ingredient to send to all of the laboratories. Officials did not say when the ingredient would be shipped, but said the process was being expedited and the material would be made available as soon as possible.

States that did not have trouble with the kits could keep using them, Kristen Nordlund, a spokeswoman for the CDC, said, adding that those states would still receive the newly made ingredient from the agency.

The flawed test kits are a separate issue from the mislabeled samples in San Diego that led officials to discharge from a hospital a woman who was sick from the coronavirus.

More than 1,380 people have died, nearly all of them in China, where there are more than 55,000 confirmed cases.

The CDC does not recommend testing for people who may have been exposed to the virus but have no symptoms. Even if they are infected, if they are still in the incubation period there may not be enough virus in their bodies for the test to detect.

The inability to detect very early infections is one reason for keeping planeloads of people from Wuhan in quarantine instead of just testing them and letting them go if the results are negative. A person could test negative and still be infected.

For the same reason, health authorities say there is no benefit to testing symptom-free people on cruise ships.

Because there is an unknown window of time between when a person becomes infected and when the test can find the virus, health officials have determined that a quarantine of two weeks — believed to be the incubation period of the illness — is the best way to make sure that people who may be infected do not transmit the virus to others.

Tests for other infectious diseases can also fail to detect some cases. A panel of tests used to screen for respiratory viruses when pneumonia is suspected can give negative results even if a patient is infected, Dr. Marrazzo said. So can rapid tests for flu and strep throat. Blood tests for HIV can miss the diagnosis in people who were recently infected.

“There is no perfect test for pretty much any infectious disease I can think of,” Dr. Marrazzo said.

Source: The New York Times

China Develops 15 Minute IgM Antibody-based COVID-19 Detection Kit

A new detection kit for the novel coronavirus pneumonia (COVID-19) has been developed. It can give a result in 15 minutes through the test of just one drop of the patient's blood, China's State Key Laboratory of Respiratory Diseases revealed on Friday.

The detection kit, which has passed preliminary lab and clinical evaluations, is the outcome of several research institutions' teamwork under the guidance of Zhong Nanshan, head of the expert panel set up by the National Health Commission (NHC) to fight against the coronavirus.

It can detect IgM antibodies, which are the first antibodies made by the body to fight a new infection, through the test of a drop of blood. The result can be delivered within 15 minutes, even when a patient's plasma is diluted 500 to 1,000 times, the lab explained.

Compared with the current RT-PCR nuclei acid tests used for diagnosis, the new test kit is simpler and more efficient, with higher sensitivity and specificity.

It can effectively break the limitations of existing detection methods on personnel and places, and shorten the test time, thus achieving a rapid diagnosis of suspected cases and screening of confirmed patients close contacts.

The detection kit has been used for tests in a hospital in Hubei Province, the epicenter of the epidemic. Some clinically diagnosed patients whose nuclei acid tests showed negative for the virus have been retested with the new kit, and most of the results showed positive for lgM antibodies.

Meanwhile, in the detection test of more than 600 clinical samples taken from Hubei and Guangzhou, the positive rate of lgM antibodies are highly in line with clinical diagnosis results.

So far, many detection kits (for scientific research) have been sent to cities in Hubei, which will be jointly used with other detection methods, such as nuclei acid tests, the lab said.

Source: Chinanews

Smart Devices Help Hong Kong Fight COVID-19

Technology is being use in the forefront to fight  for the control and prevention of the coronavirus that now has Greater China firmly in its grip. Early detection of people infected of the novel coronavirus has become an imminent challenge around the world as the epidemic continues to develop.

In Hong Kong, researchers at the Hong Kong University of Science and Technology (HKUST) and The Polytechnic University of Hong Kong (PolyU) have developed an automated diagnostic machine that can pathogens for infectious respiratory diseases.

Detection in 40 minutes

A team of researchers from the Hong Kong University of Science and Technology (HKUST) recently invented the  portable 2019-nCoV detection device.  With the latest microfluidic chip technology, the device can detect the virus in just 40 minutes from sampling to testing, compared to the currently-used polymerase chain reaction (PCR) technology which takes between 1.5 to 3 hours.

PCR technology is a molecular biotechnology used to amplify specific DNA fragments for the extraction of viral RNA, and the speed of temperature change is the key that determines the efficiency of the DNA’s amplification process, meaning the faster the temperature rises, the shorter the device can come up with a test result.

Unlike conventional large-scale PCR devices which use semiconductor to heat up testing samples, the team led by Prof. WEN Weijia from HKUST’s Department of Physics developed a novel silicon-based micro-heater module for the purpose. The micro-heater, which has lower thermal mass and a better thermal conductivity, could speed up temperature rises to around 30℃ per second from an average of 4-5℃ per second in conventional PCR devices, greatly reducing the detection time.

The detection device uses standard rapid testing tools such as those used for influenza: a quick screen is used to take a sample of the nasal cavity, which is then put into the analyser to determine the result.  Measuring just 33cm long, 32cm wide and 16cm high, the equipment set is light and portable, which is suitable for rapid on-site testing in places such as centres for disease control and prevention, customs, entry-exit inspection and quarantine departments, as well as nursing homes for the elderly.  Each device is equipped with a microfluidic portable PCR analyser, a pre-processing instrument, a bioassay chip and the novel coronavirus nucleic acid detection kits. It can test up to 8 samples simultaneously.

Leveraging on Shenzhen Shineway Technology – a biotechnology startup company co-founded by Prof. Wen and his doctoral graduate Dr. GAO Yibo, the team started this research immediately after obtaining the new coronavirus sequence on January 20 and came up with the testing kit within a week.

The new device is already in use by the Centers for Disease Control and Prevention (CDCP) in Shenzhen and Guangzhou, while two more sets were being delivered to the CDCP in Hubei and Nansha.  The device has obtained international CE certification (EU standard) and is qualified for export to all European Union (EU) countries as well as Hong Kong.

Detect up to 40 pathogens in one single test

Similarly, the researchers from PolyU have created what claims to be the world's most comprehensive automated multiplex diagnostic system, which includes a fully automated machine and a multiplex full-screening panel for the point-of-care genetic testing (POCT) of respiratory infectious diseases, including the 2019-nCoV.

"Early and accurate detection of pathogens could contribute to effective and efficient disease control and management, and prevent spreading of any contagious pathogens. It benefits the patients as well because timely therapy can then be applied to prevent complications. The existing challenge is that we lack full panel POCT technologies for early and on-site diagnosis, which should ideally be capable of differentiating between different pathogens at the same time. This newly-developed system could be a practical solution," said PolyU Professor Terence Lau Lok-ting, director of Innovation and Technology Development and adjunct professor at the Department of Applied Biology and Chemical Technology.

Professor Lau has overseen this latest project with the support of HKU Professor Yuen Kwok-yung. Through collaborative efforts, their team has spent the past four years to develop the device. The research team has received indispensable support from a local biotechnology company Avalon Biomedical Management for this project.

In the past year, the team has optimised  it and conducted trials on different clinical samples. In the midst of the 2019-nCoV outbreak, the team has also conducted tests on clinical samples using the device.

In one single test and within approximately one hour, the device can identify 30 to 40 pathogens including seasonal influenza viruses, such as influenza A subtypes H1, H2 and H3, avian influenza viruses H5, H7 and H9, human respiratory syncytial virus, severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019-nCoV.

"This fully automated, quantitative rapid diagnostic platform possesses a proprietary technology which overcomes limitations of existing technologies by ensuring sensitivity – and hence significantly enhancing the reliability of test results. Most importantly, our innovation can substantially reduce the cost of the microfluidic cartridge manufacturing thus making it feasible for wide adoption. It is ready for mass-scale production," said Professor Lau.

Leveraging the current polymerase chain reaction (PCR) technology, the system is fully automated from sample nucleic acid extraction and amplification, to signal detection and analysis. The System adopts patent-pending microfluidic and biochemical technologies that achieve ultra-sensitive detection (down to 5 gene copies) and simultaneous differentiation of various pathogens with extremely high specificity. It is also user-friendly, with manual handling not being required throughout the testing process.

"The device's versatility and capability will provide for comprehensive monitoring during disease outbreaks or routine surveillance,” said Professor Yuen. “It will become a crucial technology for ensuring the effective control of infectious diseases, medical diagnosis, and treatment."

Smart wristbands monitor potential

Meanwhile the Hong Kong Government has deployed smart wristbands to monitor city residents quarantined inside their homes. The government distributed a total of 500 smart wristbands initially, with an additional 1,000 to be produced in the coming days, if needed.

Government Chief Information Officer Victor Lam explained how the smart device works, saying the wristbands are used in conjunction with smartphones and given to people who had been to Wuhan in the past 14 days and need to quarantine at home as a result.

“This smart wristband will work together with the smartphone. So, a signal will be sent, basically exchanged, between the smartphone and the smart wristband.”

Lam said that the smart technology is designed to send an alert if quarantined individuals attempt to leave their homes.

“If the smartphone is disconnected, then an alert will be immediately sent to the Department of Health and Police for follow up,” he added. “And if the wristband is broken, an alert will also be immediately sent to the Department of Health and Police for follow. So, they work as a pair basically.”

Source: FutureIoT

Sona Nanotech Developing 5-10 Minute Coronavirus Test

A test to screen for the coronavirus that works like a pregnancy test is being developed by a Halifax company.

Screening that employs molecular-based technology costs hundreds of dollars and take hours to provide a result, but Sona Nanotech Inc. CEO Darren Rowles says his company will produce and distribute a lateral flow test for $50 that will give a primary result in five to 10 minutes.

“Most people are familiar with that form, when you say to them it’s like a pregnancy test, that style of format. But that format can be used for so many things, not just pregnancy, but infectious diseases like HIV, malaria, TB… It can be used in so many different things,” Rowles said.

One of the biggest challenges in developing any test is sourcing biological material specific to whatever is being tested for, in this case a strain of virus, Covid-19, different from previous coronaviruses like SARS (severe acute respiratory syndrome)  and MERS (Middle East respiratory syndrome).

“If you used biological material that was used to detect MERS and SARS, it wouldn’t necessarily detect very well this new coronavirus strain, the Covid-19,” said Rowles, whose company has sourced biological material from UK-based Native Antigen Co. Sona Nanotech has been devoting its resources to this project for about a month.

“I said to the team, ‘I can foresee this becoming a huge issue,’ similar to the Ebola epidemic I worked on in 2013-14, and that they’re going to need a fast screening test of some sort, however it’s deployed,” said Rowles. “So we got to work.”

The company has had calls from around the world, with pre-orders being made for a test that is probably months from coming to fruition.

“We haven’t got a test ready to go at this point, and anybody that makes a claim that they have a test ready to go in a lateral flow-based format, I would not believe that.  The key thing was making sure you had materials specific to the virus, and those materials, as far as we’re concerned, have only been made available to commercial parties this week,” the CEO said. “It’s very hard to put a time frame on it at this point because this is a brand new test, using new brand new creative materials. There’s still a lot of R&D work to be done.”

Rowles said some lab-based results might be available within two to four weeks, with a few more weeks needed to have a working lab-based prototype.

“Four to eight weeks, maybe, for some initial results, and maybe 12-16 weeks in total for a working prototype.  This is slightly uncharted territory, not your regular test development program that we would undertake,” said Rowles, who is already in contact with the Food and Drug Administration in the U.S., which is drafting the documentation required for this type of test to be submitted for approval.

Rowles expects there will be multiple commercial channels for the sale of his company’s test when it’s complete, including aid agencies, local governments, public health authorities, private hospitals and border security forces.

“Obviously, the huge demand will be from hospital laboratories and public laboratories in affected areas, specifically in China where this outbreak is happening.  Not just in China, there’s lots of countries around the world being affected by this, and other countries want to be prepared for this and put in protocols.”


A test that provides rapid results would be helpful in screening people before they enter a closed public space, like a cruise ship or an airplane, to verify if a patient can be released from quarantine and to if patients require further testing or treatment in a clinical setting.

“If you take the test and it comes back as a negative, you get to be able to be triaged to a safe zone with other negatively predicted patients, and you’re not in the same space as positive patients,” said Rowles.

Patients would probably then need to be administered the molecular-based test, but medical staff could concentrate their efforts on those who test positive. "That’s how you contain the spread of these things, you’ve got to separate people because if you’re not separating them then literally everybody’s going to get it,” he said.

Source: Journal Pioneer

Friday, February 07, 2020

University of the Philippines Develops Test Kit for Coronavirus

A test kit for the new coronavirus is being developed at the University of the Philippines' National Institutes of Health, the project's lead scientist said Tuesday.

Filipino scientists developed the test kits 2 weeks ago, after the World Health Organization released the whole genome sequence of the virus, according to Dr. Raul Destura, director of the Institute of Molecular Biology and Biotechnology.

"The limiting factor was bringing in the raw materials in the country. We’re doing the protocol for strict manufacturing process. Hopefully by next week it will be ready for DOH (Department of Health) to verify and validate," he told senators.

The Philippines previously sent specimens of persons suspected of carrying the new virus strain to the Victorian Infectious Diseases Reference Laboratory in Australia for confirmation.

The Research Institute for Tropical Medicine (RITM) in Muntinlupa received from Japan RNA primers which help identify the specific strain of virus on Jan. 29, according to Health Secretary Francisco Duque.

"The rapid diagnostic test has to undergo assessment by the experts and I defer to the WHO to guide us," he told senators.

The WHO, meantime, said its assessments of the test kits would be completed in 7 to 10 days.

"The WHO is working with several research groups both inside and outside China on the rapid diagnostic test kits," WHO representative to the Philippines Rabindra Abeyasinghe said.

"The assessments of the test kits will not be completed for about another week to 10 days, after which we have agreed we will provide test kits to Philippines and other countries."

The Philippines on Wednesday confirmed its 3rd case of the novel coronavirus--a 60-year-old Chinese woman from Wuhan who arrived in Cebu and then traveled to Bohol.

Two samples were taken from the patient- one on Jan. 23 and another on Jan. 24, with the earlier specimen confirming presence of novel coronavirus, though it came later than results of the second sample.

Samples taken from the patient on Jan. 24 tested negative when it was sent to Australia and the RITM. However, samples taken a day before tested positive at the RITM, according to results released on Monday.

Source: ABS-CBN News

HKUST Research Team Invents World’s Fastest Coronavirus Detection Device Offering Diagnostic Results in 40 Minutes

Early detection of people infected of the novel Coronavirus has become an imminent challenge around the world as the epidemic continues to develop.  A team of researchers from the Hong Kong University of Science and Technology (HKUST) recently invented the world’s fastest portable 2019-nCoV detection device.  With the latest microfluidic chip technology, the device can detect the virus in just 40 minutes from sampling to testing, compared to the currently-used polymerase chain reaction (PCR) technology which takes between 1.5 to 3 hours.

PCR technology is a molecular biotechnology used to amplify specific DNA fragments for the extraction of viral RNA, and the speed of temperature change is the key that determines the efficiency of the DNA’s amplification process, meaning the faster the temperature rises, the shorter the device can come up with a test result.

Unlike conventional large-scale PCR devices which use semiconductor to heat up testing samples, the team led by Prof. WEN Weijia from HKUST’s Department of Physics developed a novel silicon-based micro-heater module for the purpose. The micro-heater, which has lower thermal mass and a better thermal conductivity, could speed up temperature rises to around 30℃ per second from an average of 4-5℃ per second in conventional PCR devices, greatly reducing the detection time.

Leveraging on Shenzhen Shineway Technology – a biotechnology startup company co-founded by Prof. Wen and his doctoral graduate Dr. GAO Yibo, the team started this research immediately after obtaining the new coronavirus sequence on January 20 and came up with the testing kit within a week. The new device is already in use by the Centers for Disease Control and Prevention (CDCP) in Shenzhen and Guangzhou, while two more sets were being delivered to the CDCP in Hubei and Nansha.  The device has obtained international CE certification (EU standard) and is qualified for export to all European Union (EU) countries as well as Hong Kong.

The detection device uses standard rapid testing tools such as those used for influenza: a quick screen is used to take a sample of the nasal cavity, which is then put into the analyzer to determine the result.  Measuring just 33cm long, 32cm wide and 16cm high, the equipment set is light and portable, which is suitable for rapid on-site testing in places such as centers for disease control and prevention, customs, entry-exit inspection and quarantine departments, as well as nursing homes for the elderly.  Each device is equipped with a microfluidic portable PCR analyzer, a pre-processing instrument, a bioassay chip and the novel coronavirus nucleic acid detection kits. It can test up to 8 samples simultaneously.

Shineway Technology is a technology company focuses on the development of real-time in vitro diagnosis technology of nucleic acid molecules, its core team members are all researchers or graduates of HKUST.

Operation video of the microfluidic biochip detection device:

https://drive.google.com/open?id=1RQayd3FNelQEBkrBs7OWB0-Tzb9gm8rn

About The Hong Kong University of Science and Technology

The Hong Kong University of Science and Technology (HKUST) (www.ust.hk) is a world-class research university that focuses on science, technology and business as well as humanities and social science.  HKUST offers an international campus, and a holistic and interdisciplinary pedagogy to nurture well-rounded graduates with global vision, a strong entrepreneurial spirit and innovative thinking.  HKUST attained the highest proportion of internationally excellent research work in the Research Assessment Exercise 2014 of Hong Kong’s University Grants Committee, and is ranked as the world’s best young university in Times Higher Education’s Young University Rankings 2019.  Its graduates were ranked 10th worldwide and top in Greater China in Global Employability University Survey 2019.

Source: The Hong Kong University of Science and Technology

Monday, February 03, 2020

Rubix Developing Rapid Coronavirus Detection Device Modeled After Ebola Diagnostic Tool

Rubix LS Isolated Protein Binding Receptors in Ebola and Leishmaniasis Providing Rapid Spectral Analysis of Key Proteins in Real Time Its Technology Now Being Fit to Target Coronavirus

RubixLS deployed rapid diagnostic and elemental detection tools while working on pilot studies on Ebola and Leishmaniasis to countries like India and West Africa.  According to Rubix LS CEO Reginald Swift, "The technology is currently being fitted to specifically target 2019-nCoV by targeting amino acid isolates and mutative protein binding changes from bronchoalveolar fluid through breath."WHO declared coronavirus (2019-nCoV) global health emergency, the rapid scale in which China, U.S, U.K and now India have produced exposure symptoms to coronavirus has according to reports caused more than 100 deaths, 7,700 cases and rising reported so far in China, 8 cases now reported in US, latest reported in Massachusetts same state as Rubix LS is headquartered.

The CDC Newsroom telebriefing of January 30, 2020, states incubation period for coronavirus could be up to 14 days.   When asked if it is possible to detect this virus before somebody is symptomatic, Dr. Nancy Messonnier from CDC responded, "We don't know yet, and we're looking closely to see if we can.  There are two distinct ways.  One is part of our looking at the contacts around these cases is taking samples from them and perhaps hoping that not only will we fulfill a public health mission by doing that but trying to learn more about how the virus is transmitted.  There also are serological tests developed in the United States and elsewhere that could potentially help us learn more about a population level how exposure is taking place."  The CDC  confirmed in separate release that it has spread between two people in the United States, representing first instance of person to person spread with this new virus here.  According to the CDC, MERS and SARS, the other two coronaviruses that have emerged to cause serious illness in people, have also been known to cause some person-to-person spread.

"Rubix LS incorporates an AI/ML platform to specifically isolate protein binding receptor modifying behaviors that were able to target the prediction and precursor of disease evolution and potential patient diagnosis, is quickly adapting new epidemiological findings to build accuracy in its findings," states Swift.  "Our technology utilizes several skin-based sensor technologies, that is configured with communication tools, that can detect and provide a rapid spectral analysis of key proteins in real-time to a custom designed platform for data capture and validation from Rubix LS' secured databank indexed from major health agencies and research institutions globally."

Rubix LS is incorporating its AI platform toward rapidly characterizing the "spike protein" changes that identify key differences from what is observed through 2019-nCOV, SARS & MERS within minutes.  Powered by an AI platform, Rubix LS is looking to augment epidemiological datasets gathered to accurately target key configurations of mutation properties that represent a critical understanding in developing a vaccine.  The results are intended to be used with companion clinical diagnosis from credentialed health care professionals.

"At this present time, Rubix LS is in contact with the CDC to initiate development program to deploy pilot study to rapidly aggregate data to disseminate to the greater scientific community and WHO authorities to deploy robust countermeasure activities worldwide," concludes Swift.

Two New Rapid Coronavirus Tests Could Play Key Role in Efforts to Contain Growing Epidemic

Breaking research in AACC's Clinical Chemistry journal shows that two new tests accurately diagnose coronavirus infection in about 1 hour. These tests could play a critical role in halting this deadly outbreak by enabling healthcare workers to isolate and treat patients much faster than is currently possible.

Since the coronavirus emerged in Wuhan, China last month, this pneumonia-like illness has spread at an alarming rate. Just yesterday, the World Health Organization officially declared the outbreak a public health emergency, and as of today, the virus has infected nearly 10,000 people in China, with the death toll soaring to more than 200. More cases continue to appear around the globe, with six coronavirus cases already confirmed in the U.S. In order to contain this pandemic, healthcare workers need to quickly and accurately identify new coronavirus cases so that patients get crucial medical care and transmission can be halted. However, the Chinese labs that can test for coronavirus are currently overwhelmed. There are reports of hospitals in Wuhan having to deny testing for severely ill patients, who are then also denied full-time admission because beds need to be saved for those with confirmed diagnoses. Partly as a result of these testing difficulties, researchers estimate that only 5.1% of coronavirus cases in Wuhan have actually been caught.

A team of researchers led by Leo L.M. Poon, DPhil, of the University of Hong Kong has developed two rapid tests for the coronavirus that could break this diagnostic bottleneck. Using a technology known as real-time reverse transcription polymerase chain reaction (RT-PCR), the tests detect two gene regions that are only found in the Wuhan coronavirus (officially known as 2019-novel-coronavirus) and in other closely related coronaviruses such as SARS. The two gene regions detected by the tests are known as ORF1b and N. Significantly, both tests also take only about 1 hour and 15 minutes to run. This fast turnaround time could enable Chinese labs to greatly increase patient access to coronavirus testing.

To evaluate the performance of these tests, Poon's team first confirmed that the tests accurately identify genetic material extracted from cells infected with the SARS coronavirus. The researchers also showed that the tests return negative results for samples containing genetic material from other respiratory viruses, demonstrating that the tests accurately differentiate coronavirus infection from other causes of pneumonia. Lastly, Poon's team used the tests to analyze sputum and throat swab samples from two patients infected with the 2019-novel-coronavirus. The tests correctly gave positive results for both patients.

"Signs of [coronavirus] infection are highly non-specific and these include respiratory symptoms, fever, cough, [shortness of breath], and viral pneumonia," said Poon. "Thus, diagnostic tests specific for this infection are urgently needed for confirming suspected cases, screening patients, and conducting virus surveillance. The established assays [in this study] can achieve a rapid detection of 2019-novel-coronavirus in human samples, thereby allowing early identification of patients."