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A coronavirus breathalyzer is a diagnostic medical device enabling the user to test with 90% or greater accuracy the presence of severe acute respiratory syndrome coronavirus 2 in an exhaled breath.As of the first half of 2020, the idea of a practical coronavirus breathalyzer was concomitantly developed by unrelated research groups in the Singapore, United States, The Netherlands, Finland, Germany, Israel, England, Australia, Indonesia, Canada, Poland and United Kingdom.
People with COVID-19 have higher levels of aldehydes, compounds produced when cells or tissues are damaged by inflammation, and ketones, which fits with research suggesting that the virus may damage the pancreas and cause ketosis. Diagnostics researchers hope to find the components in exhaled air that are truly characteristic of a disease and develop more specific sensors for them, This is done by studying breath samples using sensors in parallel with mass spectrometry analyses.
Different diseases may cause similar breath changes. Diet can affect the chemicals someone exhales, as can smoking, alcohol consumption and medicines.
In Australia, GreyScan CEO Samantha Ollerton and Prof. Michael Breadmore of the University of Tasmania are basing a coronavirus breathalyzer on existing technology that is used around the world to detect explosives.
Canary Health Technologies, headquartered in Toronto with offices in Cleveland, Ohio, is developing a breathalyzer with disposable nanosensors using AI-powered cloud-based analysis. According to a press release, clinical trials began in India during November 2020.The stated goal is to develop an accurate, reasonably priced screening tool that can be used anywhere and deliver a result in less than a minute. The company postulates that analyzing volatile organic compounds in human breath could potentially detect diseases before the on-set of symptoms, earlier than currently available methods. Moreover, the cloud-based technology is designed to be used as a disease surveillance apparatus.
By the end of June 2020, Forum Virium Helsinki, in collaboration with Finnish software firm Deep Sensing Algorithms, funded by the Helsinki-Uusimaa Regional Council,announced that testing of their device had begun with a control group in Kazakhstan, with plans to expand to the Netherlands, the United States, South Africa, Brazil and Finland throughout the summer. The efficacy of the Forum Virium Helsinki / Deep Sensing Algorithms device hinges on its AI component. "We are engaged in innovative cooperation with corporations to solve the coronavirus crisis, and we will help firms to use the city as a development platform. We are utilizing artificial intelligence and digitalization," said Forum Virium Helsinki CEO Mika Malin.
In March 2020, the Singaporean company RAM Global conducted research in Germany in hopes of developing a one-minute breathalyzer test for SARS-CoV-2 based on terahertz time-domain spectroscopy. The company attempted to develop a disposable test kit for direct detection of COVID-19 virion particles in breath, saliva and swab samples.On 31 March, RAM Global completed an initial clinical study on live patients at University Hospital Saarland. In April, the company pursued a small unknown sample study in which hospital doctors provided unknown samples in order to test accuracy in differentiating positive and negative samples. The company named its product platform ThEA, or Terahertz Express Analyzer.
Since April 2020, a team of researchers from Gadjah Mada University (UGM) has been developing an electronic nose called GeNose C19.The GeNose C19 can be used as a rapid, non-invasive screening tool in less than two minutes. A profiling test was carried out at the Bhayangkara Hospital and the Covid Bambanglipuro Special Field Hospital in Yogyakarta. GeNose C19 consists of gas sensors and an artificial intelligence-based pattern recognition system. The diagnostic test was carried out with the cooperation of nine multi-center hospitals.
In the end of December 2020, GeNose C19 received a distribution permit from Indonesia's Health Ministry. Initially, 100 units will be released and each device will be able to perform 120 tests per day. The test is estimated to cost 15,000–25,000 Indonesian rupiah ($1–$1.8) and would take three minutes for the test and another two minutes to yield a result. Researchers hope to manufacture up to 1,000 GeNose C19 units, increasing the country's testing capabilities by 120 thousand subjects per day.Moreover, they aim to manufacture 10,000 units by February 2021.
In Israel, it is at the photonics lab of Gabby Sarusi, professor at Ben-Gurion University of the Negev, that research is underway as of midsummer 2020.Separately from Sarusi's project, in July 2020, it was reported that Israeli start-up Nanoscent in cooperation with Sheba Medical Center had devised a breathalyzer that Magen David Adom (MDA) is seeking to incorporate into existing drive-thru testing stations located throughout the country.
Questionable intellectual property of Gabby Sarusi regarding this project is now under discussion in the court in Israel.
A breath test with the SpiroNose device, made by the Dutch company Breathomix,has been developed and tested in collaboration with the Leiden University Medical Center (LUMC), Franciscus Gasthuis & Vlietland and the GGD Amsterdam. The breath test has been validated as a pre-screening test for people who have no or mild symptoms of COVID-19. From April 2021, the device was operational in COVID-19 test drive-ins, conferences and events, i.e. Eurovision Song Contest 2021. Subjects must abstain from alcohol for eight hours prior to taking the breath test.
The SpiroNose contains four sets of seven different sensors that can measure the mixture of volatile organic compounds (biomarkers) in the exhaled air. These VOCs provide a picture of a person's metabolism. This ‘breath profile’ is forwarded to an online analysis platform. Here the breath profile is compared with other breath profiles of people with and without a COVID-19 diagnosis and analysed by algorithms. Data-analysis involves advanced signal processing and statistics based on independent t-tests followed by linear discriminant and ROC analysis. The test result is known within minutes.
The breath test has a sensitivity/specificity for SARS-CoV-2 infection of 100/78, >99/84, 98/82% in validation, replication and asymptomatic cohorts of patients. The breath test reliably detects who is not infected. Such a subject will receive a test result immediately. Other subjects must promptly conduct a subsequent test, for example a PCR test or LAMP test. The test results can be viewed by the client and are not automatically interfaced to other databases, i.e. for public health surveillance, source and contact tracing, vaccination programs.In additional control tests in July 2021, it was not possible to obtain sufficiently reliable results specific for the GGD test drive-in setting. Additional investigation of the cause(s) is needed.
The analysis platform is developed conform the requirements of the standard ISO 27001 (Information Security) and NEN 7510 (Information Security in Health Care). A CE marking has been requested. In the meantime, the Dutch minister has granted a CE marking exemption on 25 January 2021. The device may also be used to detect other diseases, e.g., asthma, COPD, lung cancer, interstitial lung diseases (ILD).
In February 2021, the President of Poland, Andrzej Duda, announced that ML System S. A., headquartered in Zaczernie, Poland, had successfully developed a means of analyzing a patient's breath to test for the presence of coronavirus.According to an anonymous press release, test subjects exhale into a device in order to determine the presence of the coronavirus. The procedure, similar to that of a police breathalyzer, is said to take less than ten seconds. Independent clinical trials were begun in April 2021. In the first half of May 2021, a brief text concerning partial results was published by ML System, stating that independent clinical trials were successful with specificity (97,15%) and accuracy/sensitivity (86,86%), for CT (Cycle Threshold) assumed at 25, which is in line with the guidelines set out by the World Health Organisation. Moreover, ML System in partnership with Rzeszów–Jasionka Airport published a statement indicating their intention to test the device at the airport. Similar plans exist between the manufacturer and the Warsaw Chopin Airport. Two large networks of laboratories in Poland, "Diagnostyka" and "ALAB Laboratoria", have signed a letter of intent with ML System. In agreement with ALAB, the parties declared cooperation in the implementation of the product named "COVID DETECTOR" on the Polish, German and Ukrainian markets. In addition, the companies declared joint activities aimed at extending the diagnosis with the use of "COVID Detector" to include mutations of the SARS-CoV-2 virus, differentiate the stage of the disease and other pathogens, including tuberculosis. Cooperation with laboratories Diagnostyka, including detection of mutations of SARS-CoV-2 virus or other pathogens, also involves the diagnosis of cancer with the use of the device.
In January 2021, Exhalation Technology Ltd (ETL) in Cambridge announced a clinical trial study for a cohort of up to 150 patients for its CoronaCheck breath test for COVID-19.
In June 2020, American researchers at UCLA and Ohio State University received grants to test coronavirus breathalyzer concepts, one of which could produce results in 15 seconds. The testing system would be able to take certain compounds of an individual breath to detect coronavirus.“The goal in this research is to develop cheap, massively deployable, rapid diagnostic and sentinel systems for detecting respiratory illness and airborne viral threats,” says Prof. Pirouz Kavehpour of UCLA Henry Samueli School of Engineering and Applied Science, whose research team received a one-year, $150,000 research grant from the National Science Foundation.
Commercial Research Developments
Technology start-up Global e∙dentity™ founder Dr. Robert Adams first discussed chemosensory biometrics detection during a TEDx talk in Norwich England July 2019 and by February 2020 the company had focused its chemosensory detection developments on the emerging SARS-CoV-2 (Covid-19) pandemic. The team discovered that it could distinguish between the odor of individuals with asymptomatic or mild symptomatic SARS-CoV-2 infection and uninfected individuals, essentially they had identified the chemical odor signature associated with the metabolism of Covid-19 on a human or non-human. The team went on to tune the associated AI algorithms to achieve an almost faultless 100% detection accuracy and to file and be granted the first Covid detection patent 29 Dec 2020:U.S. Patent number 10880303. Global e∙dentity™ fourth patent issued in two years.
In immunology, seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization. After seroconversion has occurred, the antibodies can be detected in blood tests for the disease. During an infection or immunization, antigens enter the blood, and the immune system begins to produce antibodies in response. Before seroconversion, the antigen itself may or may not be detectable, but the antibody is, by definition, absent. During seroconversion, the antibody is present but not yet detectable.
A breath test is a type of test performed on air generated from the act of exhalation.
A breathalyzer or breathalyser is a device for estimating blood alcohol content (BAC), or to detect viruses or diseases from a breath sample.
Mouth breathing is breathing through the mouth. It often is caused by an obstruction to breathing through the nose, the innate breathing organ in the human body. Chronic mouth breathing may be associated with illness. The term "mouth-breather" has developed a pejorative slang meaning.
Bronchoalveolar lavage (BAL) is a diagnostic method of the lower respiratory system in which a bronchoscope is passed through the mouth or nose into an appropriate airway in the lungs, with a measured amount of fluid introduced and then collected for examination. This method is typically performed to diagnose pathogenic infections of the lower respiratory airways, though it also has been shown to have utility in diagnosing interstitial lung disease. Bronchoalveolar lavage can be a more sensitive method of detection than nasal swabs in respiratory molecular diagnostics, as has been the case with SARS-CoV-2 where bronchoalveolar lavage samples detect copies of viral RNA after negative nasal swab testing.
Canine cancer detection is an approach to cancer screening that relies upon the claimed olfactory ability of dogs to detect, in urine or in breath, very low concentrations of the alkanes and aromatic compounds generated by malignant tumors.
Point-of-care testing is defined as medical diagnostic testing at or near the point of care—that is, at the time and place of patient care. This contrasts with the historical pattern in which testing was wholly or mostly confined to the medical laboratory, which entailed sending off specimens away from the point of care and then waiting hours or days to learn the results, during which time care must continue without the desired information.
Lateral flow tests (LFTs), also known as lateral flow immunochromatographic assays or rapid tests, are simple devices intended to detect the presence of a target substance in a liquid sample without the need for specialized and costly equipment. These tests are widely used in medical diagnostics for home testing, point of care testing, or laboratory use. For instance, the home pregnancy test is an LFT that detects a specific hormone. These tests are simple, economic and generally show results in around five to 30 minutes. Many lab-based applications increase the sensitivity of simple LFTs by employing additional dedicated equipment.
Breath diagnostics involves the analysis of a sample of human breath to monitor, diagnose, and detect diseases and conditions. Besides its primary constituents – nitrogen, oxygen, carbon dioxide and water vapour – exhaled human breath contains over one thousand other compounds at trace levels. Many of these species are formed as the by-products of metabolic processes and can be indicative of a number of different diseases and conditions. Examples of such biomarkers are outlined below:
Breath gas analysis is a method for gaining information on the clinical state of an individual by monitoring volatile organic compounds (VOCs) present in the exhaled breath. Exhaled breath is naturally produced by the human body through expiration and therefore can be collected in non-invasively and in an unlimited way. VOCs in exhaled breath can represent biomarkers for certain pathologies. Breath gas concentration can then be related to blood concentrations via mathematical modeling as for example in blood alcohol testing. There are various techniques that can be employed to collect and analyze exhaled breath. Research on exhaled breath started many years ago, there is currently limited clinical application of it for disease diagnosis. However, this might change in the near future as currently large implementation studies are starting globally.
DiaSorin is an Italian multinational biotechnology company that produces and markets in vitro diagnostics reagent kits used in immunodiagnostics and molecular diagnostics and since July 2021, it is also active in the Life Science business. The group was founded in 2000 and is headquartered in Saluggia, Italy. Its production is at several plants located in Europe and the United States: Saluggia and Gerenzano (Italy), Dietzenbach (Germany), Stillwater, Minnesota (US), Dartford (UK). Following the acquisition of Luminex, the Company acquired five additional production plants located in the USA and in Canada (Toronto). The company is a constituent of the FTSE MIB index.
Cepheid is an American molecular diagnostics company. Its systems automate traditional nucleic acid tests. The tests can be used to identify and analyze pathogens and genetic disorders. Cepheid sells clinical tests for healthcare-associated infections, infectious diseases, sexual health, oncology and genetics.
A nasopharyngeal swab is a device used for collecting a sample of nasal secretions from the back of the nose and throat. The sample is then analyzed for the presence of organisms or other clinical markers for disease. This diagnostic method is commonly used in suspected cases of whooping cough, diphtheria, influenza, and various types of diseases caused by the coronavirus family of viruses, including SARS, MERS, and COVID-19.
Janice Chen is co-founder and chief research officer of the South San Francisco-based company, Mammoth Biosciences, which is applying DETECTR, its programmable DNA detection technology, to reliable and rapid COVID-19 detection leading to quick diagnoses in even asymptomatic coronavirus patients. Founded in 2017, Mammoth uses CRISPR as a genetic “search engine” to alert researchers of disease markers it identifies. As a graduate student at the University of California at Berkeley, Chen worked in the lab of CRISPR pioneer Jennifer Doudna, receiving her PhD in Molecular and Cell Biology. Other Mammoth Biosciences founders are Jennifer Doudna, Lucas Harrington, CEO Trevor Martin and CTO Ashley Tehranchi--all Bay Area-trained scientists; at founding, the company set out to apply CRISPR technology to new frontiers.
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease has since spread worldwide, leading to an ongoing pandemic.
COVID-19 testing involves analyzing samples to assess the current or past presence of SARS-CoV-2. The two main branches detect either the presence of the virus or of antibodies produced in response to infection. Molecular tests for viral presence through its molecular components are used to diagnose individual cases and to allow public health authorities to trace and contain outbreaks. Antibody tests instead show whether someone once had the disease. They are less useful for diagnosing current infections because antibodies may not develop for weeks after infection. It is used to assess disease prevalence, which aids the estimation of the infection fatality rate.
COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research, with 419 potential COVID-19 drugs in clinical trials, as of April 2021.
Abingdon Health is a British manufacturer of lateral flow assay diagnostic tests, sometimes called rapid tests, lateral flow immunoassays (LFIA), lateral flow tests (LFT) or quick tests. Since its formation in 2008, Abingdon Health has grown to become an organisation of over 200 people and has developed and manufactured lateral flow rapid tests across multiple industries.
EpiVacCorona is a peptide-based vaccine against COVID-19 developed by the VECTOR center of Virology. It consists of three chemically synthesized peptides that are conjugated to a large carrier protein. This protein is a fusion product of a viral nucleocapsid protein and a bacterial MBP protein. The third phase of a clinical trial, which should show whether the vaccine is able to protect people from COVID-19 or not, was launched in November 2020 with more than three thousand participants.
The development of COVID-19 tests was a major public health priority during the early months of the COVID-19 pandemic.