Friday, April 03, 2020

VTT Begins Development of Rapid Test for Coronavirus

VTT Technical Research Centre of Finland has started work on a new Covid-19 test based on the detection of viral antigens in nasopharyngeal samples.

The development of the test is being carried out in collaboration with the Meilahti Vaccine Research Center, a joint research facility run by the University of Helsinki and Helsinki University Hospital (HUS).

The test is designed to be performed by healthcare professionals, with results delivered in 15 minutes or less. VTT also hopes to make the new test considerably more cost-efficient than existing testing methods.

Antibody development has already commenced and the first versions of the new tests are expected by autumn.

VTT biosensors research team leader Dr Leena Hakalahti said: “As the situation with the epidemic began to worsen internationally, we started looking for solutions within our area of excellence. We have expertise in antibody development and production as well as previous experience in designing diagnostic tests. It was an easy decision for us to start working on the Covid-19 antibody.”

HUS is also playing an important role in the research. The samples used have been collected by HUS from patients who have had the coronavirus infection.

VTT began the project to develop new antibodies to the SARS-CoV-2 virus using internal funding, but is now urgently seeking additional funding and partners for the development of the rapid response test.

The tests and their analysis equipment could be carried out in Finland by VTT and other Finnish companies. In addition to responding to domestic needs, they could be sold internationally.

VTT research area vice president Dr Jussi Paakkari said: “Increasing the testing capacity plays a key role in monitoring the progress of the epidemic, but current testing methods require a lot of time and resources, which limits the capacity. The purpose of the rapid test is to enable growing the testing capacity and ensuring the availability of tests even as the epidemic continues.”

BD and BioMedomics Develop Blood Test to Detect Covid-19 Antibodies

Biotech company BD and BioMedomics have launched a new blood test to detect antibodies in blood to confirm current or past exposure to coronavirus (Covid-19) within 15 minutes.

Developed and manufactured by BioMedomics, the point-of-care rapid serology test identifies antibodies that are generated by the body as a result of Covid-19 infection.

The antibodies, which are normally present during the middle and final stages of infection, may remain in the body after the exposure.

It will help clinicians to determine past exposure to Covid-19 even if a patient no longer exhibits symptoms.

Data on past exposure is considered to be vital for researchers in understanding the possible occurrence of SARS-CoV-2 infection across a population. The information can aid future strategies for fighting the pandemic.

BD Integrated Diagnostic Solutions president Dave Hickey said: “Serology tests are important because they provide an additional piece of information to aid in characterising possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity.

“Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test along with molecular diagnostics could be helpful in ruling out Covid-19.”

The test can analyse blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies related to SARS-CoV-2.

IgM enables the first line of defence during viral infections, while high-affinity IgG is generated afterwards for long-term immunity and immunological memory.

The detection of Covid-19 IgM antibodies hints a recent exposure to the disease and the detection of Covid-19 IgG antibodies indicates a later stage of infection.

The combined antibody test could also help identify the stage of the disease in patients.

BioMedomics CEO Frank Wang said: “Our test has been clinically validated at several hospitals and clinical laboratories in both the US and China and our published clinical data in the Journal of Medical Virology was one of the world’s first for a Covid-19 serology test.

“It has been used widely in China during the Covid-19 outbreak and is now ready to help combat coronavirus in the US through our collaboration with BD.”

The companies also noted that additional testing may be required, depending on the clinical scenario, to further evaluate the possibility of SARS-CoV-2 infection.

Tuesday, March 31, 2020

Indiana University Develops Real-Time COVID-19 Diagnostic Tests

Indiana University researchers from the School of Informatics and Computing at IUPUI and the School of Medicine, in collaboration with Indiana University Health, are developing new diagnostic tests that combine speed and sensitivity for rapid detection of the viral strain.

These tests can eventually be employed for faster diagnosis of health care workers and others who are on the front lines and exposed to COVID-19 patients.

Benchtop and palm-held sequencing-based approaches being developed by IU principal investigator Sarath Janga and colleagues provide solutions for real-time detection of viral infections in clinical samples and further means to control the outbreaks.

"The issue with current accepted approaches for COVID-19 tests is that, while effective at detection, they are slow, with results taking up to a day or longer. We are testing our benchtop sequencing approach, which can potentially be done in two to three hours or even less," Janga said.

An additional advantage of this novel approach is that testing may be performed at point-of-care in the clinic, rather than transferring samples to the lab, further reducing time and the risk of more infections.

Given these challenges, the team hopes to leverage the findings from these new rapid tests to generate quantitative or semi-quantitative data that can be used to identify the COVID-19 strains prevalent in Indiana and reconstruct the development and evolution of the virus to inform surveillance, public health strategy and potential vaccine design going forward.

Janga's lab is also supporting current ongoing COVID-19 testing by providing personnel and necessary reagents to the clinical pathology lab at IU Health.

"Viral outbreaks such as COVID-19 need real-time detection of the status of infection in patients to control the spread," Janga said. "Since there are currently no specific treatments for coronavirus infections, and strains of these RNA viruses evolve rapidly, it is crucial to develop novel techniques that can provide rapid diagnostics and therapeutic intervention."

Like coronavirus, several viral strains are pathogenic in nature, difficult to detect and easy to transmit, leading to the emergence of pandemics. In the case of an outbreak, it is important to have a method to detect the virus as quickly and accurately as possible in order to prevent its transmission and efficiently treat infected patients.

Currently, most clinical diagnostic tests for viruses depend on either detecting viral antigens or on PCR amplification of viral nucleic acids. These two approaches offer trade-offs and benefits. Antigen tests are typically rapid but have low sensitivity, while PCR is more time-consuming and more sensitive.

Janga and his team are employing a commercially available Oxford Nanopore Technologies sequencing platform that generates full-length DNA or direct RNA virus sequences from clinical samples.

Janga, an associate professor in bioinformatics and data science in the School of Informatics and Computing at IUPUI, and visiting research associate Quoseena Mir, from the Department of Biohealth Informatics in the School of Informatics and Computing, are collaborating with Ryan Relich, head of the IU Health Clinical Pathology Laboratory and assistant professor of clinical pathology and laboratory medicine at IU School of Medicine, and Dr. Raj Vuppalanchi, director of the clinical hepatology division in the IU School of Medicine's Department of Medicine.

Source: Indiana University News

Battelle and Wexner Medical Create New COVID-19 Diagnostic Test

Battelle and The Ohio State University Wexner Medical Center have jointly developed a new rapid, sensitive diagnostic test for COVID-19. The Ohio State Wexner Medical Center will administer the new test under its existing FDA certification permits. This will increase and improve test processing in Ohio according to existing state clinical guidelines.

The new rapid test will allow for faster turnaround time on test results, which will help “flatten the curve.”

Battelle researchers spent several weeks working in the company’s West Jefferson labs to develop a diagnostic assay and complete a validation process, with early results suggesting exceptionally high sensitivity.

Since March 14, more than 100 Ohio State Wexner Medical Center researchers and clinicians have worked with Battelle researchers nights and weekends to stand up the lab that will support COVID-19 testing. After enough data was gathered by researchers at both institutions, Ohio State processed its first 91 tests for diagnosis Wednesday using cutting-edge Battelle and Ohio State equipment in a Centers for Medicare & Medicaid Services (CMS)-certified pathology lab at Ohio State.

Battelle is now working to bring a second lab online in West Jefferson, with the intent of making more test processing available. Battelle is in the process of receiving a Clinical Laboratory Improvement Amendment (CLIA) from CMS to begin its own clinical testing.

“Ohio State and Battelle teams have shown incredible leadership and ingenuity in moving this project forward so rapidly,” said Ohio Gov. Mike DeWine. “With this collaboration, we will increase testing right here in Ohio to better help health care professionals and public health officials understand, treat and prevent the spread of the virus.”

Results of the test can be available in as few as five hours. Initially, the system can process approximately 200 tests per day, but when the infrastructure is fully built over the coming weeks, the goal is to process more than 1,000 test swabs per day.

“Battelle has decades of experience in infectious disease research and has worked with virtually all federal health and national security agencies to respond to emerging health threats,” said Lou Von Thaer, Battelle’s president and CEO. “I am incredibly proud of the Battelle team, the speed at which it was able to work around the clock to quickly get this operational, and our collaboration with The Ohio State University.”

Battelle’s infectious disease, genetic and virology experts teamed up with researchers and scientists across Ohio State’s College of Medicine, including immunologists, microbiologists, pathologists, epidemiologists and data analytics researchers for this project.

“We’re proud of the partnership of our dedicated scientists with Battelle researchers to help find innovative solutions for the coronavirus pandemic sweeping the world,” said Dr. Hal Paz, executive vice president and chancellor for health affairs at Ohio State and CEO of the Ohio State Wexner Medical Center. “Our physicians and nurses are eager to start administering these tests that will greatly increase our capacity to diagnose more people and assist us in finding solutions for this disease. Testing is just one of more than 50 new research areas aimed at combatting COVID-19 underway at the Wexner Medical Center. We are working hand in hand with Battelle on many of these critical projects.”

Battelle is contributing its expertise and using its specialty facilities, including the largest, private BSL-3 laboratory in the United States, and is actively working on several other solutions related to the COVID-19 pandemic.

COVID-19 testing requires an order from a physician or other advanced practice provider. Based on feedback from the Ohio Department of Health, testing is prioritized for inpatients in hospitals and other facilities, outpatients who are moderately ill but who are at high risk for serious illness (e.g, elderly, immune compromised, underlying lung disease, etc.), health care providers and first responders. Asymptomatic patients do not need to be tested.

People who believe they need to be tested should contact their primary care provider, local hospital or your local health department for further direction.

Monday, March 30, 2020

Philippines FDA Approves Five COVID-19 Rapid Test Kits Despite Accuracy Concerns

The Philippines Food and Drug Administration (FDA) announced on Monday that it has approved COVID-19 rapid test kits despite the Department of Health’s preference for real-time polymerase chain reaction (RT-PCR) based test kits.

FDA Director General Eric Domingo said they have approved the use of 5 brands of rapid test kits. "We approved kits that are registered and used in countries with advanced technology and wide experience with COVID-19,” he said in a statement.

These are the Nanjing Vazyme 2019-nCoV IgG/IgM Detection Kit, the Novel Coronavirus (2019-NCOV) IgM/IgG Antibody Detection Kit (Colloidal Gold Method), the Diagnostic Kit for IgM/IgG Antibody to Coronavirus (Sars-CoV-2) (Colloidal Gold), the 2019-nCoV Antibody Test (Colloidal Gold) and the SARS-CoV-2 Antibody Test (Lateral Flow Method). The test kits are from China and Singapore.


Domingo also announced the FDA’s approval of the SARS Cov2 kit of Gene Xpert, as well as their coordination with Abbott Laboratories, which invented a test that can detect the COVID-19 virus within 5 minutes.

“Both tests were recently approved by the US FDA and can detect the virus in just a few minutes,” Domingo said in Filipino. He said they are awaiting for the production of the said test kits.

Unlike the rapid test kits, this one is PCR-based like the 17 other test kits already approved by FDA for commercial use.

For the past weeks, the FDA has only been approving PCR-based test kits, which the Department of Health considers the “gold standard” for COVID-19 testing. PCR-based test kits are used in laboratories to extract genetic material from throat and nose swab samples to compare it with the COVID-19 virus.

Rapid test kits, on the other hand, only measure the antibodies from a patient’s blood samples.

Domingo said that while the DOH does not believe that rapid test kits can be used for mass screening, it will yield a faster result, making it useful in some cases, such as when there is an immediate need to test a patient with severe symptoms or for communities where there is an outbreak. However, it is not as accurate as PCR-based kits.

During a televised briefing, Doming explained in Filipino that the results of rapid test kits must be interpreted by a health professional.

FDA is requiring all rapid test kits to have the following label: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

“The body takes time to develop antibodies and this might give a negative result for patients who have been infected but have not yet developed antibodies,” Domingo said. “A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” he added.

He emphasized that the rapid test kits cannot be used at home as it requires the preparation of a solution and the proper handling of the drug samples. “This is important because blood can be used to transmit diseases like hepatitis or HIV,” Domingo said.

Because of the backlogs due to limited test kits and laboratories, it takes 5 to 7 days to get COVID-19 test results. But the DOH said it will soon go back to 24 to 48 hours once they are done testing backlog samples.

The FDA reminded local government units to be careful with the test kits they are using.

Recently, one mayor posted a photo of the rapid test kits that his LGU purchased for his city. However, the FDA said it cannot be used yet because it has not been approved.

It also called on the DOH to increase the number of laboratories for the PCR-based tests.

“We are also calling on doctors to help and guide in the use of test kits and to properly explain the results to patients,” Domingo said.

The FDA official also warned against fake or unregistered medicine and medical devices.

Head of NanoBio Lab Develops 5-Minute Coronavirus Test

Professor Jackie Ying, who heads the NanoBio Lab at the Agency for Science, Technology and Research (A*Star), and her team have come up with a rapid test that can tell if a person has Covid-19 in as little as five minutes. When approved, this would be about the fastest test out there for Covid-19.

They hope to submit the test for approval in a month's time. The test looks for the genetic material of the virus in a patient's secretions collected from a swab.

This sample is then put in a portable device that will give the result in about five to 10 minutes, using an extremely rapid amplification method that they have named Cepat.

"We have done some preliminary clinical validation at the KK Women's and Children's Hospital using real patients' samples, and found the test to be very sensitive and accurate," said Prof Ying.

Once it is approved, the technology can be used to make such kits for use in hospitals. It will also be adapted for use in general practitioner clinics, said Prof Ying.

She and her team are among the researchers here and around the world who are racing to come up with point-of-care tests that can tell you if you have Covid-19 much faster than the current standard lab test. The challenge, Prof Ying said, is to develop rapid and accurate diagnostics that can be done without the use of expensive machines.

As the pandemic grows, the spotlight is increasingly falling on testing as a way to contain the spread - for the lack of it has potentially been hiding a large number of cases.

The World Health Organisation has emphasised the need to "test, test, test", as it allows cases to be picked up earlier and promptly isolated, before they spread it to more people.

Some countries are able to do widespread testing; others, like the United States, are experiencing a shortage of tests.

In Singapore, testing started in January at the National Centre for Infectious Diseases, where the National Public Health Laboratory is based. By the end of January, all of Singapore's public hospitals could test for Covid-19, said the group director of medicine at the National University Health System, Professor Dale Fisher. Singapore then tested anyone coming to a hospital with a respiratory illness and anyone who had been in contact with a Covid-19 patient.

"Less than 1 per cent of tests are positive, which reflects the large number being done," he said. These are the standard lab tests that look for the genetic material of the virus in the patient's secretions, often collected with a nasopharyngeal swab.

The test takes at least two to three hours to show results and requires the use of specialised machines. If samples need to be transported, the turnaround time is even longer.

These tests work by first converting the coronavirus' RNA to DNA in a method known as reverse transcription (RT). Then, the polymerase chain reaction (PCR) technique is used to amplify the genetic material of the virus so that it can be easily detected. It is called the RT-PCR test. "It is essentially a molecular photocopier. PCR was invented in 1984, and even in today's machines, about 60 per cent of the time is spent waiting for the PCR machine to heat up and cool down," said Prof Ying.

The latest invention by her and PhD student Muhammad Nadjad Abdul Rahim is a new method to amplify specific DNA/RNA at a single temperature. Just like PCR, their method can "photocopy" the genetic material of the virus millions of times. The difference in their new method is that they can hit a rate of millions of copies within a minute.

One key reason is that unlike PCR, their approach does not require any heating and cooling between each controlled amplification step. This is enabled by a special enzyme developed in Prof Ying's lab.

Prof Ying said she and her team of scientists have been working tirelessly for around six weeks to come up with the fast test, after A*Star's chief executive Frederick Chew gave them the challenge of coming up with rapid tests for Covid-19. Earlier, A*Star had developed PCR test kits for use here and overseas, and has passed the baton to local firm MiRXES, which can mass produce them.

Another local biotech firm Veredus Laboratories developed a three-hour PCR test kit that is being used at checkpoints here.

Associate Professor Hsu Li Yang, the programme leader for infectious diseases at the National University of Singapore's Saw Swee Hock School of Public Health, said that there are many diagnostic tests and kits being developed in China and the US, as well as those by local companies such as MiRXES and Veredus Laboratories, and it is a matter of time before the ones from overseas are available here.

US firm Cepheid has received emergency authorisation from the US Food and Drug Administration for its rapid molecular test, which can be used at the point of care for patients and gives a result in 45 minutes. It makes use of machines to run the test, which are already available in Singapore hospitals.

Other types of tests done to find Covid-19 in patients are the sero-logical tests. These look for immunoglobulins, which are the antibodies made by the immune system to fight the virus - in patients' blood.

These antibodies take a few days to show though, and will not appear in the early stage of the disease. Hence, a blood test will not detect Covid-19 if someone has just been infected with it.

Duke-NUS Medical School was the first in the world to develop a serological test that was put to good use last month to trace two people who were the source of infection of two clusters here. The two had mild symptoms, were not hospitalised and had recovered, but the test found they had antibodies against the coronavirus.

As serological tests pick up such mild cases, they can be done to ascertain the extent of community spread, as well as asymptomatic spread. Such tests, however, take several hours to show results. Fast test kits solve the problem but it is very important to note the sensitivity of the tests, said Prof Ying.

There is little point using a very fast test kit when it cannot detect the virus in you most of the time. Or, worse, it may tell you that you are not sick, even though you are infected with Covid-19. The latter is what is called a false negative, and it can happen, for instance, when the test kit is unable to pick up the virus in a person with a low viral load.

People infected with Covid-19 are believed to shed large quantities of the virus early in their illness (high viral load) and less later on. Hence, it would be best if a fast test can pick up the infection from a patient at various stages of the disease, regardless of whether he has a high or low viral load, said Prof Ying.

On Saturday, the US Food and Drug Administration said it is already beginning to see unauthorised fraudulent test kits that are being marketed to test for Covid-19 in the home.

Fraudulent health claims, tests and products may keep some patients from seeking care or delay necessary medical treatment, it said. "When you run a test, you must know what you are testing for," said Prof Ying.

An RT-PCR test should be able to detect the disease in someone who is in the earlier stage of the disease, when he is shedding more of the virus, and, therefore, likely more infectious.

On the other hand, a serological test can find antibodies in someone who is at the late stage or recovered, when he is shedding less or none of the virus, she said.

"This crisis has forced Singapore to re-examine whether we have the ability to do the various things needed to fight it and we do," she said. "We can do the science and we can also develop our own tests."

Source: The Straits Times 

Fluxergy Submits Request For FDA Emergency Use Authorization (EUA) For One-Hour COVID-19 Test At Point-Of-Care

Fluxergy LLC, a research and medical diagnostic test company based in Irvine California, has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company's high-speed Research Use Only (RUO) test system as a COVID-19 diagnostic at the point-of-care (POC).

The Fluxergy Analyzer system, which utilizes state-of-the-art PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in under one hour in bench lab tests performed by the company and in follow-up validation tests with patient samples completed this week by researchers at University of California San Diego (UC San Diego). The UC San Diego physician-scientist research team that conducted the validation, completed on March 27, 2020, has been led by Dr. Davey Smith, Professor of Medicine and Head of the UCSD Division of Infectious Diseases and Global Public Health. Dr. Smith is a member of the Fluxergy Medical Advisory Board.

Advanced rapid point-of-care PCR tests for COVID-19 like the Fluxergy Analyzer system may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy's on-site sample-to-answer test for COVID-19 requires a very small sample, typically a nasal swab. This swab is mixed with a reagent solution, loaded onto the Fluxergy card and inserted into the Fluxergy Analyzer in a convenient two-step procedure.

"The worldwide shortage and inaccessibility of COVID-19 tests have been major impediments to containing the pandemic in the U.S. and globally," said Dr. Ali Tinazli, Chief Commercial Officer at Fluxergy. "We are gratified to be progressing toward the next important milestone in the development of our point-of-care diagnostic technology."

About Fluxergy

Fluxergy, launched in 2013 with funding support of investor John Tu, co-founder of Kingston Technologies, seeks to provide a portable, highly sophisticated and easy to use sample-to-answer POC platform that enables clinicians to cost-effectively conduct a wide range of multiplex and multimodal in vitro diagnostic tests (different types of tests all at once, up to 30 targets). Fluxergy's solution is a portable testing platform based on three core elements: the single-use consumable Fluxergy Card, the Fluxergy Analyzer, and its user interface Fluxergy Works. The Fluxergy Analyzer and the single-use consumable Fluxergy Cards (lab-on-chip) are designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing and microfluidics technologies. Leveraging Fluxergy Works Software, as many as 256 Fluxergy Analyzers can be managed with one local server and linked to the Cloud to provide powerful access to help manage patient data.

Friday, March 27, 2020

Abbott Launches 5-Minute COVID-19 Isothermal Point-of-Care Test

Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments.

The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is already the most widely available molecular point-of-care testing platform in the U.S. today.

ID NOW features a unique isothermal nucleic acid amplification technology targeting COVID-19 RdRp gene, all within a self-contained test cartridge. Instead of thermal cycling, the system uses enzymes to rapidly drive the amplification process.

"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus," said Robert B. Ford, president and chief operating officer, Abbott. "With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots."

Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have the greatest impact.

Abbott is ramping up production to deliver 50,000 ID NOW COVID-19 tests per day, beginning next week, to the U.S. healthcare system.

The arrival of the Abbott ID NOW COVID-19 test comes a week after the company launched its Abbott m2000™ RealTime SARS-CoV-2 EUA test, which runs on the m2000™ RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about 5 million tests per month.

When not being used for COVID-19 testing, ID NOW is the leading molecular point-of-care platform for Influenza A&B, Strep A and respiratory syncytial virus (RSV) testing. Our platform holds the largest molecular point-of-care footprint in the U.S. and is already widely available in physicians' offices, urgent care clinics, and hospital emergency departments across the country.

"Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the front lines, where testing capabilities are needed most," said Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott. "Portable molecular testing expands the country's capacity to get people answers faster."

Bosch and Randox Develop Rapid Test for the Simultaneous Detection of COVID-19 and Nine Other Respiratory Viruses with Similar Symptoms, Including Influenza and Other Human Coronaviruses

Bosch Healthcare Solutions, together with Randox Laboratories Ltd., has developed one of the world’s first fully automated molecular diagnostic tests for COVID-19. The rapid molecular diagnostic test runs on the Vivalytic analysis device from Bosch Healthcare Solutions.

Developed in just six weeks, the rapid test can detect a SARS-CoV-2 coronavirus infection in patients in under two and a half hours, measured from the time the sample is taken to the time the result arrives. Another advantage of the rapid test is that it can be performed directly at the point of care. This eliminates the need to transport samples, which takes up valuable time. It also means patients quickly gain certainty about their state of health, while allowing infected individuals to be identified and isolated immediately. With the tests currently in use, patients must usually wait one to two days for a result.

Bosch’s rapid test is one of the world’s first fully automated molecular diagnostic tests that can be used directly by all medical institutions. What’s more, it allows a single sample to be tested not just for COVID-19 but also for nine other respiratory diseases, including influenza A and B, simultaneously.

The new test utilises Randox Biochip Technology, reporting 540 results in less than 5 hours on the Randox Evidence Investigator, a semi-automated analyser that is capable of processing 54 patient samples simultaneously.

Randox Laboratories have developed a game-changing point of care coronavirus test. The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.

The newly developed test will be available in Germany starting in April, with other markets in Europe and elsewhere to follow.

In various laboratory tests with SARS-CoV-2, the Bosch test delivered results with an accuracy of more than 95%. The rapid test meets the quality standards of the World Health Organization (WHO). A sample is taken from the patient’s nose or throat using a swab. Then the cartridge, which already contains all the reagents required for the test, is inserted into the Vivalytic device for analysis. During the analysis, medical staff can devote themselves to other tasks, for example treating patients.

The Vivalytic analyzer is designed to be so user-friendly that even medical personnel who have not been specially trained on it can reliably perform the test. A Bosch Vivalytic analyzer can perform up to ten tests in the space of 24 hours. This means it takes just 100 devices to evaluate up to 1,000 tests per day. Given the dynamic spread of the coronavirus SARS-CoV-2, laboratories are already working beyond capacity. The Bosch Vivalytic will thus help to increase available testing capacities.