Saturday, January 23, 2021

Microfluidic Chip Detects COVID Antibodies in Seconds

Engineers at Pittsburgh’s Carnegie Mellon University have used 3D printing to create a microfluidic chip that detects COVID antibodies in 10-12 seconds.

Using a minuscule drop of blood of just five microlitres, the platform can identify the presence of two of the virus’s antibodies – spike S1 protein and receptor binding domain (RBD). Even low concentrations of antibodies below one picomolar (0.15 nanograms per millilitre) can be detected by the device, which relies on an electrochemical reaction within the microfluidics to send a signal to a nearby smartphone or computer. The research is published in Advanced Materials.

“We utilised the latest advances in materials and manufacturing such as nanoparticle 3D printing to create a device that rapidly detects COVID-19 antibodies,” said Rahul Panat, an associate professor of mechanical engineering at Carnegie Mellon who uses specialised additive manufacturing techniques across his biomedical research.

To create the device, the team used an additive technique known as aerosol jet 3D printing. Tiny, inexpensive gold micropillar electrodes were printed at nanoscale by thermally sintering aerosol droplets together. This causes a rough, irregular surface that provides increased surface area of the micropillars and an enhanced electrochemical reaction, where antibodies can latch on to antigens coated on the electrode. The specific geometry allows the micropillars to load more proteins for detection, resulting in very accurate, quick results.

According to the Carnegie Mellon team, the test has a very low error rate because the binding reaction between the antibody and antigen used in the device is highly selective, and the team was able to exploit this natural phenomenon to its advantage. In addition to detecting COVID antibodies, the platform can also be used to gauge immune response in individuals, which could prove useful as COVID vaccines are rolled out across the world.

“Because our technique can quantify the immune response to vaccination, it is very relevant in the current environment,” said Panat.

As the sensing platform is generic, it could also be used for the rapid detection of biomarkers for other highly infectious diseases such as Ebola, HIV, and Zika.

FDA Issues Emergency Use Authorization for MatMaCorp's COVID-19 2SF RNA Test for the Detection of SARS-CoV-2

MatMaCorp (Materials and Machines Corporation), a developer of comprehensive molecular diagnostic systems, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of MatMaCorp’s COVID-19 2SF RNA test for the detection of SARS-CoV-2 on the company’s Solas 8® portable detection system. MatMaCorp is the first company announced by the National Institutes of Health (NIH) to exclusively focus on expanding COVID-19 testing in rural areas, as part of the NIH’s $1.5 billion Rapid Acceleration of Diagnostics (RADx) initiative.

The NIH launched the RADx initiative specifically to support the development and commercialization of innovative technologies to increase the U.S. testing capacity for SARS-CoV-2, the coronavirus that causes COVID-19. The funding will help scale MatMaCorp’s COVID-19 testing solutions for use in association with CLIA labs at critical access hospitals, health systems, and mobile sites. MatMaCorp is dedicated to providing its COVID-19 testing solutions to many regions in rural America, starting with Nebraska and expanding to Iowa, Kansas, North Dakota and South Dakota.

Dr. Abe Oommen, MatMaCorp founder and President, said, “As a diagnostics company founded and headquartered in Nebraska, we are committed to serving our rural and agricultural communities. With the financial support and regulatory guidance from NIH and the RADx initiative, and now with FDA Emergency Use Authorization, we can help increase COVID-19 testing for our underserved communities that feel left behind.”

The Centers for Disease Control and Prevention (CDC) have advised that rural communities may be at higher risk during the COVID-19 pandemic.1 According to the CDC, an estimated 46 million Americans live in rural areas, where there are fewer medical facilities to provide care during the COVID-19 pandemic.2 There are approximately 300 critical access hospitals in the four-state region that encompasses Iowa, Kansas, Nebraska, North Dakota, and South Dakota.

“Critical access hospitals play a pivotal role in serving our rural communities, but they are currently hindered by lack of onsite testing, limited allocation of tests, and high costs of current devices,” said Phil Kozera, CEO at MatMaCorp. “To help improve care in our rural communities, we plan to provide our COVID-19 tests and platform to CLIA labs at select critical access hospitals starting with Nebraska and expanding in the central United States. MatMaCorp’s COVID-19 2SF RNA test and Solas 8 portable device are ideally suited to provide reliable results for surveillance and routine testing.”

MatMaCorp’s COVID-19 2SF RNA test and Solas 8 portable detection system are designed to make COVID-19 testing accessible and cost-effective at CLIA-certified sites. The portable testing platform can rapidly perform multiple RT-PCR assays and has been validated by six independent locations across the country. MatMaCorp’s COVID-19 2SF RNA test is an RT-PCR test intended to detect the genetic material of SARS-CoV-2 from nasopharyngeal swab specimens collected from patients suspected by their healthcare provider of having contracted COVID-19 and may be used by any lab that is CLIA-certified to perform high-complexity testing.

T2 Biosystems T2SARS-CoV-2 Panel Proves Effective Amid Global Rise in Variants of the SARS-CoV-2 Virus

T2 Biosystems, Inc., a leader in the rapid detection of sepsis-causing pathogens, today announced that its T2SARS-CoV-2™ Panel—a molecular diagnostic test that detects SARS-CoV-2, the virus responsible for COVID-19 infections—is capable of detecting the multiple variants of the SARS-CoV-2 virus most recently identified in the United Kingdom, South Africa, and the United States.

“As new strains of the COVID-19 virus emerge, it is critical that we ensure our technology continues to be an effective diagnostic solution during the ongoing pandemic,” said T2 Biosystems’ President and CEO, John Sperzel. “I’m proud that we can confidently say, after extensive analysis, that our T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100 percent, can continue to help impact lives by detecting multiple variants of the SARS-CoV-2 virus.”

Both the variants identified in the United Kingdom (B.1.1.7) and South Africa (B.1.351) contain multiple mutations, most reflected in the S gene, which encodes the spike protein. To confirm that the T2SARS-CoV-2 Panel would detect these variants and other potential mutations of SARS-CoV-2 viruses, an in silico analysis was performed using genome sequences available in the National Center for Biotechnology Information (NCBI) nucleotide database and GISAID database.

Over 42,000 genome sequences for SARS-CoV-2 were evaluated for alignment with primer and probe sequences from T2SARS-CoV-2 Panel. This analysis demonstrated that the T2SARS-CoV-2 Panel should detect 99.99% of all SARS-CoV-2 viruses based on sequence alignments. A specific analysis of sequences for B.1.1.7 and B.1.351 variants confirmed that the T2SARS-CoV-2 Panel should be able to detect these variants.

The T2SARS-CoV-2 Panel provides results in under two hours utilizing an upper respiratory swab sample. The test runs on the Company’s FDA-cleared and fully-automated T2Dx® Instrument, which is capable of performing seven tests simultaneously and up to sixty samples per day.

The same T2Dx Instrument is also capable of running the FDA-cleared T2Bacteria® Panel and T2Candida® Panel. These panels are the only FDA-cleared assays for the detection of sepsis-causing bacterial and fungal pathogens directly from whole blood in three to five hours, without the need to wait days for blood culture results. By providing quicker results, the panels enable clinicians to target therapy faster for their patients suspected of sepsis, often before the second dose of antimicrobial medicine is administered, leading to better patient outcomes, improved antimicrobial stewardship, and reductions in length of stay in the hospital.

These additional panels remain especially clinically relevant during the pandemic, as data suggests that the COVID-19 virus can lead to sepsis, and death.

Cepheid Receives Health Canada License for SARS-CoV-2, Flu A, Flu B and RSV Combination Test

Cepheid announced that Health Canada has issued Cepheid a medical device license for Xpert® Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The test is now available in Canada and can be used in laboratories and at the point of care. The four-in-one test is designed for use on any of Cepheid's almost 30,000 GeneXpert® Systems placed worldwide, with results delivered in approximately 36 minutes.

"The ability to run a single, highly-sensitive test that detects SARS-CoV-2, Flu A, Flu B, and respiratory syncytial virus provides actionable results and helps to alleviate pressure on the healthcare system," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "Xpert® Xpress SARS-CoV-2/Flu/RSV delivers reference lab quality testing in a cartridge that can be run near-patient, often providing results while patients are being seen or admitted. Rapid results help healthcare workers make real-time patient management decisions including qualification for antiviral therapy and triage for emergency procedures."

Cepheid's previously announced capacity expansion program, supported by parent company Danaher Corporation, was designed in part to address anticipated demand for Xpert Xpress SARS-CoV-2/Flu/RSV.

"The dramatic impact of SARS-CoV-2 has been felt by us all, and we understand that a reliable supply of SARS-CoV-2 tests is critical to the communities our healthcare institutions serve — for the coming Flu season and beyond," said Cepheid President Warren Kocmond. "Another goal of the capacity expansion program is to ensure supply continuity of not only our 4-Plex combination test for SARS-CoV-2, Flu A&B and RSV, but the entire portfolio of critical tests Cepheid supplies — including tests for tuberculosis, MRSA, C. difficile, CT/NG, Strep A, and many more."

Digital CRISPR‐assisted assay for rapid detection of SARS‐CoV‐2

The discovery of CRISPR enzymes isolated from bacteria has not only transformed our ability to edit the genome and therefore treat a number of genetic disorders, but has also opened the door to enhanced diagnostic testing.

Nucleic acid tests detect genetic information such as DNA and RNA, and are often used in the identification of viruses or bacteria. They are currently being widely used in the detection of the SARS-CoV-2 virus — for which there has been an unprecedented demand in response to the COVID‐19 pandemic — with the LMAP (loop-mediated isothermal amplification) test being one of the most common.

CRISPR-based nucleic acid assays are faster, more reliable, specific, and cheaper in comparison, and have already found application in the detection of the Dengue virus (DENV), human papillomavirus (HPV), and Zika virus (ZIKV).

Yet their lack of digitization has hindered them, says a team of scientists led by Professor Jeff Wang from Johns Hopkins University. “All CRISPR-based assays to date are performed in reaction tubes or reaction wells,” said Wang. “This reaction format has two shortcomings: the viral load in a sample is difficult to quantify because it is only loosely related the signal intensity, [and] samples with low viral loads require longer time to produce a detectable signal.”

Digital detection is also a powerful and reliable tool that enhanced the diagnostic capabilities of tests such as PCR and LAMP, yet no digital enhancement has been realized for their CRISPR-based counterparts.

Creating a sensitive, digital CRISPR assay

To solve this problem, the team developed an assay they call deCOViD (digitization‐enhanced CRISPR/Cas‐assisted one‐pot virus detection), which is the first digital CRISPR/Cas‐assisted assay that can detect SARS‐CoV‐2 RNA and heat‐inactivated SARS‐CoV‐2 in a single step. Their results were recently published in Advanced Science.

“Our digital CRISPR-based assay can count individual viruses in a sample,” said Wang. “It also maintains a constantly rapid assay time for samples with both high and low viral loads.”

The assay uses fluorescent signalling to detect the presence or absence of the virus — it integrates transcription and amplification of viral RNA into one step and then these RNA fragments activate RNA-guided CRISPR complexes to trigger fluorescence in positive samples.

“Detecting SARS-CoV-2 virus in a sample is like the proverbial problem of finding a needle in a haystack,” explained Wang. “Imagine that even if the needle can make copies of itself, it can still take a long time to make enough copies of needles and become visible in the haystack. But if the haystack is first divided into many smaller piles and the needle is in one of the smaller hay piles, then the needle needs to make less copies of itself to be visible enough in the smaller piles thereby it will take shorter time to be detected. We used the same strategy. When we divide our assay and SARS-CoV-2 viruses into 20000 tiny wells, each virus in its tiny well can be detected faster and at the same time as viruses in other wells.”  

To test the feasibility of deCOViD in clinical testing, the researchers tested four samples obtained from nasal swabs, which included two SARS‐CoV‐2 positive samples, one SARS‐CoV‐2 negative sample, and one influenza sample, and compared it against a conventional, multi-step CRISPR-based assay they termed a “bulk assay”. To confirm the results, all tests were run against a standard PCR assay.

“Both the bulk assay and deCOViD yielded higher signals from the two positive samples than those from the negative sample — indicating successful detection results that agree with RT‐qPCR,” wrote the authors. “In addition, for the influenza sample, both the bulk assay and deCOViD yielded signals that are indistinguishable from those from the negative sample, which matches RT‐qPCR while also illustrating the specificity of both methods.”

In a final test, the team diluted their nasal samples by two-fold and found the virus became undetectable to the bulk assay but was successfully detected by deCOViD. This is because RNA amplification and sampling is carried out in digital reaction wells, where every copy of the target is isolated at a locally elevated concentration, facilitating rapid amplification that is independent of the initial sample’s concentration. This not only provides a more sensitive test, but enhances detection time.

When will they be used on the front lines?

“Our work so far has been an academic pursuit, but we are certainly interested in commercializing our assay and contributing to mass screening and testing for SARS-CoV-2 in the near future,” added Wang. “It is expected that several improvements in user-friendliness can facilitate the commercialization of our work, which include simplification of fluorescence detection of digital chip and automation of sample loading process.”

Assay components can also be further optimized to detect SARS-CoV-2 even faster and directly from different samples such as saliva, he continued. Fluorescence detection can can also be simplified by either using a commercialized chip reader that is compatible with the digital chip or by implementing a mobile phone-based fluorescence detection system.

“As deCOViD can be readily designed for other DNA or RNA targets, we foresee applying it toward other diseases,” the team wrote in their paper. “Based on the encouraging results and potential for improvement, we believe deCOViD can open a new avenue for advancing CRISPR/Cas‐assisted diagnostic assays and provide a new tool for combating the COVID‐19 pandemic and beyond.”

Reference: Joon Soo Park, et al., Digital CRISPR/Cas‐Assisted Assay for Rapid and Sensitive Detection of SARS‐CoV‐2, Advanced Science (2020). DOI: advs.202003564

LexaGene to Detect UK and South African COVID Sequences

Molecular diagnostics company, LexaGene, announced that it has initiated a program that uses the rapid configurability of the MiQLab™ system to investigate novel variants of SARS-CoV-2, the pathogen that causes COVID-19.

SARS-CoV-2 is a pathogen that mutates quickly. New variants were recently identified in the United Kingdom (B.1.1.7) and South Africa (B.1.351). Both new strains appear to be about 70% more contagious, making containment that much more challenging. Also, some scientists are concerned that the South African strain may not be a good match for developed vaccines and antibody-based therapeutics. 

Dr. Jack Regan, LexaGene’s CEO and Founder states, “It is hard to estimate the impact of a new variant that can re-infect those who have already been infected or vaccinated. It is critical that we have the capability to not only detect whether the patient is COVID-19 positive, but also whether they are, in fact, infected with a new variant. We need to be able to more quickly and accurately identify new strains at the point-of-care, as this potentially could have helped better contain SARS-CoV-2 at the start of the outbreak.”

LexaGene is pursuing FDA EUA for COVID-19 testing using assays that are predicted to detect >99.9% of the strains circulating today based on published sequences, including the UK and South African variants. Given the suspected higher rate of transmissibility of these variants, it is of clinical importance to be able to distinguish these new variants from the original strain. LexaGene’s MiQLab can be easily configured to run tests for both coronavirus detection and strain identification as it is capable of screening for up to 27 genetic targets at once.

Dr. Regan continues, “We founded LexaGene to fill a critical technology gap in our defenses against new pathogens. LexaGene’s MiQLab is designed to be a point-of-care system that is open-access in nature. Once a pathogen emerges or mutates, the MiQLab system is designed to quickly onboard new tests to detect a desired target, which would speed up timelines for point-of-care testing. Detecting these variants quickly inside hospitals, clinics, and other testing locations maximizes the chances of successfully containing these new threats.”

To date, there is no FDA approved device that is designed for point-of-care usage and is open-access.

LexaGene has designed and ordered components for tests to distinguish the UK and South African strains from the traditional coronavirus strain and will confirm these work as expected on the MiQLab system 

At this time, LexaGene has no plans to incorporate these new tests into the FDA studies for Emergency Use Authorization (EUA) for COVID-19 testing, which began late last month.

As is standard practice, until the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.

Saturday, January 09, 2021

Estonian Researchers Develop Unique Coronavirus Rapid Test

The University of Tartu and SelfDiagnostics, a medical equipment supplier, have developed a SARS-CoV-2 rapid molecular test that allows detecting the viral RNA (one of the three major biological macromolecules that are essential for all known forms of life, along with DNA and proteins) at a lower price and a greater resource efficiency; the test allows identifying infection on the spot in less than an hour.

The current method regularly used for virus identification is PCR, polymerase chain reaction, where the nucleic acid is amplified in stages at different temperatures. This method regularly presumes purification of the nucleic acids from the sample.

The PCR method is, however, time-consuming and requires complex laboratory equipment, special facilities and trained staff. This makes current testing relatively expensive and resource intensive. From the patient point of view, current centralised testing has two major drawbacks, significant delay in the results (usually days) and uncomfortable or even painful sampling of the nasopharynx.

Identifying the infection within 45 minutes

The University of Tartu researchers and Estonian-German company SelfDiagnostics have now developed a coronavirus rapid test that allows identifying the infection within 45 minutes.

The test is based on the isothermal amplification of nucleic acids, meaning that the presence of viral RNA is determined at a constant temperature. This means there is no need for large laboratory equipment or conditions and the test can be performed on-site or at the point of the patient care. Clinical studies indicate that the accuracy of the novel molecular rapid PCR test is similar to that of central laboratories.

According to Katrin Krõlov, the lead of the R&D activities, the test aims to get an accurate diagnostic result at the site of patient care. “Above all, the test is a faster and a more affordable alternative to current testing system,” Krõlov said. “For example, if you are travelling by plane, it is not very helpful if you are informed that you were on the same flight with a corona-positive person a couple of days after the flight. The rapid test, however, would allow identifying the infected people before boarding.”

A single-use mini-laboratory

Ülo Langel, a professor of molecular biotechnology, explained that the rapid test allows expanding testing in the regions where the fast diagnosing of the coronavirus is vital. “The testing should be diffused and close to the patient. The bigger goal is to allow people test themselves without burdening the healthcare system. It would save valuable time in diagnosing fast spreading infection, where current testing system meets the limit,” Langel said.

SelfDiagnostics has been developing different diagnostic products for the past ten years. According to its CEO, Marko Lehes, they have successfully modified a previously developed infection rapid test to detect both the SARS-CoV-2 virus and influenza viruses. “The rapid test has the accuracy of a laboratory with the size of a human palm. We can say that it is basically a single-use mini-laboratory,” Lehes said.

U of Birmingham Scientists Develop New COVID-19 Test That Gives Positive Result in Minutes

A new COVID-19 test that reduces testing time from 30 minutes to less than five and delivers accurate results has been developed by researchers at the University of Birmingham.

The researchers believe their method could deliver a test that is not only fast but also sufficiently sensitive. The test does not require samples to be treated at high temperatures, and it can be performed using standard laboratory equipment, making it readily deployable.

A preprint paper (yet to be peer reviewed) describing the new process has been published on MedRxiv in which the researchers demonstrate the rapidity and sensitivity of their method using patient sample RNA provided by Public Health England. 

Professor Tim Dafforn from the University’s School of Biosciences commented: “We have designed a new method for testing that combines the ease of use and speed of lateral flow testing with the inherent sensitivity of an RNA test.  It features reagents that can be used in existing point of care devices and meets the need for testing in high throughput, near-patient, settings where people may be waiting in line for their results.” 

The most accurate COVID-19 tests currently in use require detecting viral RNA - the most common of these use a technique called PCR (polymerase chain reaction). The PCR test is a two-step process, which involves first converting to the RNA to DNA and then ‘amplifying’ the material many times over.

The new Birmingham test simplifies the method to a single step and uses an alternative amplification method called EXPAR (Exponential Amplification Reaction). This technique uses very short, single strands of DNA for the replication process, which can be completed in a matter of minutes, making a significant reduction in the overall time needed to produce results.

The entire test can be run on standard laboratory equipment at lower temperatures compared to PCR tests, which require higher temperatures to separate out strands of DNA as part of the amplification process.

University of Birmingham Enterprise has filed a patent application covering this novel method for amplifying RNA sequences, and its use for detecting RNA in a sample. 

The researchers, made up of cross-disciplinary team from the University of Birmingham’s School of Biosciences, School of Chemistry and the Institute of Cancer and Genomic Sciences, anticipate that further development work could lead to a simple handheld test being developed which could give ‘on the spot’ results.

Professor Jim Tucker, from the University’s School of Chemistry says: “The EXPAR technique has been tried and tested over several years, but we’ve been able to apply it in a new way to detect COVID-19. This is an extremely promising approach to developing a rapid, accurate test which could increase NHS testing capability by up to five times.”

The research is funded by a BBSRC doctoral training scheme, the Midlands Integrative Biosciences Training Partnership (MIBTP). The team are currently applying for funding from UK Research and Innovation to develop the test for NHS laboratories.

Professor Andrew Beggs, from the University's Institute of Cancer and Genomic Sciences, says: “More rapid testing will allow us to unlock near patient testing, getting people safely back to work and controlling outbreaks when they happen. The development of the EXPAR test will allow us to produce more tests that can rapidly diagnose COVID-19”

While the method was developed specifically to reduce testing time and increase testing throughput in COVID-19 testing, in the long-term, the use of the EXPAR technology is expected to extend to other RNA-based viruses and infectious agents such as bacteria, as well as other diseases including cancer. 

Bruker Introduces MBT Sepsityper® Kit US IVD for Rapid Identification of > 400 Microorganisms from Positive Blood Cultures

Bruker Corporation announced US FDA clearance and the US launch of the MBT Sepsityper Kit US IVD for rapid microbial identification of more than 425 microorganisms from positive blood cultures on the MALDI Biotyper CA System.

Dr. Wolfgang Pusch, Executive Vice President Microbiology & Diagnostics at Bruker Daltonics, stated: “This represents an order of magnitude increase in the number of microorganisms that can be identified rapidly from positive blood cultures in suspected bacterial or fungal sepsis cases compared to targeted PCR detection. This could make the MBT Sepsityper Kit US IVD a nearly universal, rapid sepsis identification solution for clinical microbiology. We expect this affordable fast assay to benefit large numbers of patients, as it comes at a fraction of the cost of expensive syndromic panels with limited species coverage. Faster identification can assist infectious disease physicians and pharmacists in switching sepsis patients to appropriate antibiotics or antifungals for local or hospital infection patterns, which reduces costs, length of ICU stays and could save lives.”

The MBT Sepsityper Kit US IVD enables the rapid identification of many microorganisms from positive blood culture bottles. Harvested microorganisms are processed, and then identified using the FDA-cleared MALDI Biotyper CA System, with a reference library that covers 425 different gram-negative and gram-positive bacterial species and groups, as well as yeasts, including Candida auris, an emerging pathogen for hospital-acquired candidiasis.

The MBT Sepsityper Kit US IVD workflow typically takes less than 30 minutes from a positive blood culture bottle alert to identification. It can save up to 24 hours in time-to-result (TTR) for many identifications, versus additional agar plate culturing, and a further 8–12 hours for biochemical identification after agar plate culturing. The MBT Sepsityper Kit US IVD workflow does not test for resistance or antibiotic susceptibility. It rapidly identifies the microbial species once the blood culture system has detected microbial growth.

Mr. Ike Northern, Director of Infectious Disease Testing and Immunology at the CompuNet Clinical Laboratory in Dayton, Ohio, explained: “I think a lot of laboratories are realizing that they need to use MALDI-TOF MS technology for microbial identification. Many are now making this investment when they recognize the long-term patient and cost benefits. The MBT Sepsityper Kit US IVD will be the next step for a lot of clinical microbiology laboratories. Many are currently using multiplex PCR tests, but once you have the MALDI Biotyper instrument, it is more cost-effective to use the MBT Sepsityper Kit US IVD for fast identification than PCR syndromic panels.” (*)

Rapid testing from positive blood cultures is gaining increasing interest in the clinical microbiology community due to high mortality and morbidity rates in sepsis and septic shock. Sepsis impacts an estimated 30 million patients worldwide every year, many of whom die or suffer permanent health issues. Survival rates can be increased by rapid initiation of an appropriate antibiotic therapy ( Developed for use with Bruker's U.S. FDA-cleared MALDI Biotyper CA System, the MBT Sepsityper Kit US IVD is intended to simplify and speed up identification of microorganisms directly from positive blood cultures of sepsis patients.

Dr. Elisabeth C. Shearon, the Medical Director at Alverno Laboratories in Hammond, Indiana, commented: “Rapid (MBT) Sepsityper identification has become instrumental in terms of our patient care. Especially in critically ill patients, the improved turn-around-time allows disease specific treatment which conserves health-care resources and, most importantly, improves patient outcomes.” (*)

Currently, guidelines call for physicians to treat septic patients quickly with broad-spectrum antibiotics with the goal of switching to a more targeted therapy once the infecting organisms have been identified and/or any antibiotic resistances have been determined. The MBT Sepsityper Kit US IVD can improve this process by providing rapid microbial identifications to help clinical microbiologists, treating physicians, and patients alike.

Dr. Steven D. Burdette, the Chief of Infectious Diseases at the Miami Valley Hospital in Dayton, Ohio added: “The MBT Sepsityper kit data has allowed us to adjust antibiotic therapy according to our local antibiogram. This, at times, has allowed us to narrow or stop certain antibiotic treatments while in other cases, it has allowed us to escalate antibiotic coverage pending sensitivity data. It has become a crucial tool for our Antimicrobial Stewardship team.” (*)

* All quoted early adopters have self-validated the research-use-only (RUO) version of the MBT Sepsityper kit prior to FDA-clearance of the MBT Sepsityper Kit US IVD.

New COVID-19 Test from Turkey Can Be A Game-Changer

The new nanotechnology-based diagnostic system can detect the COVID-19 virus within 10 seconds with a swab taken from the mouth.

The system, is called Diagnovir and developed within the infrastructure of Bilkent UNAM, the joint work of Dr. Bülend Ortaç and his team, Bilkent Holding and E-A Technology operating in Bilkent Cyberpark Technology Development Zone.

It is an optically based diagnostic and identification system that changes the color of the glow in the presence of the virus, thus detecting viruses with high selectivity.

In this system, pathogens are detected within 10 seconds by dynamically receiving a fluorescent signal via a pathogen detection chip developed specifically for a biosensor device.

Physiologist Dr. Ali Aytaç Seymen, the researcher at Bilkent UNAM, said that after saliva sample taken from the mouth. If the sample is positive, the system shows it in about 10 seconds and if it is negative, it analyzes longer and shows results in 20 – 30 seconds.

After the sample taken from the patient, it is mixed with a special solution, dropped on the pathogen detection chip, and if there is a pathogen in the environment by the biosensor device, the presence of pathogens with high accuracy is detected by taking the fluorescent signal.

Taking saliva samples from the mouth instead of taking swab samples from deep areas such as the oropharynx and nasopharynx will also make the use of the system preferable.

Unlike the commonly used PCR tests, the system is not based on sample replication, but on detecting the presence or absence of the virus with advanced optical methods.

In the system, optical and electronic modules that provide both precise virus detection and high selectivity in detection, as well as high-level biotechnology and material science knowledge are used. The system has shown 99% success in virus detection in pre-clinical studies conducted so far.

We believe that the system will be widely used in Turkey and in the world as a fast and reliable virus detection method. Therefore, the necessary infrastructure investments for the mass production of this biosensor system have already started. The mass production phase is planned to start within an estimated 2 months, right after completing the necessary permissions from Ethics Committee Turkey Pharmaceuticals and Medical Devices Agency (TİTCK) within the shortest time. Accordingly, it will be possible to contribute to the control of the pandemic and to significantly relieve social life.

In order to protect the intellectual rights of this innovation, patent applications of the system have been made recently.

The system has high export potential. All marking, certification, and accreditation steps that will pave the way for domestic and international sales have also started.