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 (http://www.worldsepsisday.org). 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.