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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. [1] As of the first half of 2020, the idea of a practical coronavirus breathalyzer was concomitantly developed by unrelated research groups in Australia, Canada, Finland, Germany, Indonesia, Israel, Netherlands, Poland, Singapore, United Kingdom and USA. [2] [3]
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. [4]
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. [5] 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. [6] [7]
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, [8] 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. [9] The efficacy of the Forum Virium Helsinki / Deep Sensing Algorithms device hinges on its AI component. [10] "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. [11]
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. [12] 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. [13]
Since April 2020, a team of researchers from Gadjah Mada University (UGM) has been developing an electronic nose called GeNose C19. [14] 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. [15] 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. [16]
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. [17] Moreover, they aim to manufacture 10,000 units by February 2021. [18] [19]
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. [20] 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. [21]
Questionable intellectual property of Gabby Sarusi regarding this project is now under discussion in the court in Israel. [22] [23] [24]
A breath test with the SpiroNose device, made by the Dutch company Breathomix, [1] 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.[ citation needed ]
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.[ citation needed ]
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. [25] [26] In July 2021, the ministry stopped the tests with the SpiroNose because, according to the GGD, the device gives unusable results in some cases. Breathomix indicates that this is the result of the way in which the SpiroNose is deployed. The SpiroNose is and remains a reliable instrument for lung diseases.[ citation 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).[ citation needed ]
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. [27] 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. [28] 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 Organization. [29] Moreover, ML System in partnership with Rzeszów–Jasionka Airport published a statement indicating their intention to test the device at the airport. [30] Similar plans exist between the manufacturer and the Warsaw Chopin Airport. [31] 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.[ citation needed ]
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. [32]
"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. [33]
In April 2022, the FDA authorized for emergency use the first COVID-19 diagnostic test using breath samples. [34] [35] "The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath," said the FDA. [34]
Researchers at the Washington University in St. Louis in 2023 reported developing a point-of-care COVID-19 test device using a sensor to directly detect the SARS-CoV-2 virus in exhaled breath. In early testing, the experimental breathalyzer design provided results with high accuracy in about a minute. It functions by collecting a breath sample and directing it towards an electrochemical biosensor coated with antibodies specific to the SARS-CoV-2 virus. If the virus is present, the sensor produces a signal, indicating a positive test. This approach directly detects the virus itself, unlike some breath tests that identify indirect markers of infection. [36] [37] [38] [39] In late 2023, the researchers announced they had been awarded a $3.6 million grant to investigate the possibility of adapting the device to include testing for other respiratory viruses, such as influenza, and to further develop and commercialize their breathalyzer technology. [40]
A surgical mask, also known by other names such as a medical face mask or procedure mask, is a personal protective equipment used by healthcare professionals that serves as a mechanical barrier that interferes with direct airflow in and out of respiratory orifices. This helps reduce airborne transmission of pathogens and other aerosolized contaminants between the wearer and nearby people via respiratory droplets ejected when sneezing, coughing, forceful expiration or unintentionally spitting when talking, etc. Surgical masks may be labeled as surgical, isolation, dental or medical procedure masks.
A breath test is a type of test performed on air generated from the act of exhalation.
A breathalyzer or breathalyser, also called an alcohol meter, is a device for measuring breath alcohol content (BrAC). It is commonly utilized by law enforcement officers whenever they initiate traffic stops. The name is a genericized trademark of the Breathalyzer brand name of instruments developed by inventor Robert Frank Borkenstein in the 1950s.
A lateral flow test (LFT), is an assay also known as a lateral flow device (LFD), lateral flow immunochromatographic assay, or rapid test. It is a simple device intended to detect the presence of a target substance in a liquid sample without the need for specialized and costly equipment. LFTs are widely used in medical diagnostics in the home, at the point of care, and in the laboratory. For instance, the home pregnancy test is an LFT that detects a specific hormone. These tests are simple and economical and generally show results in around five to thirty minutes. Many lab-based applications increase the sensitivity of simple LFTs by employing additional dedicated equipment. Because the target substance is often a biological antigen, many lateral flow tests are rapid antigen tests.
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 United States and in Canada (Toronto). The company is a constituent of the FTSE MIB index.
Cepheid is an American molecular diagnostics company that is a wholly owned subsidiary of Danaher Corporation. 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.
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by the coronavirus SARS-CoV-2. The first known case was identified in Wuhan, China, in December 2019. Most scientists believe the SARS-CoV-2 virus entered into human populations through natural zoonosis, similar to the SARS-CoV-1 and MERS-CoV outbreaks, and consistent with other pandemics in human history. Social and environmental factors including climate change, natural ecosystem destruction and wildlife trade increased the likelihood of such zoonotic spillover. The disease quickly spread worldwide, resulting in the COVID-19 pandemic.
COVID-19 testing involves analyzing samples to assess the current or past presence of SARS-CoV-2, the virus that cases COVID-19 and is responsible for the COVID-19 pandemic. The two main types of tests detect either the presence of the virus or 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.
The transmission of COVID-19 is the passing of coronavirus disease 2019 from person to person. COVID-19 is mainly transmitted when people breathe in air contaminated by droplets/aerosols and small airborne particles containing the virus. Infected people exhale those particles as they breathe, talk, cough, sneeze, or sing. Transmission is more likely the closer people are. However, infection can occur over longer distances, particularly indoors.
Part of managing an infectious disease outbreak is trying to delay and decrease the epidemic peak, known as flattening the epidemic curve. This decreases the risk of health services being overwhelmed and provides more time for vaccines and treatments to be developed. Non-pharmaceutical interventions that may manage the outbreak include personal preventive measures such as hand hygiene, wearing face masks, and self-quarantine; community measures aimed at physical distancing such as closing schools and cancelling mass gathering events; community engagement to encourage acceptance and participation in such interventions; as well as environmental measures such surface cleaning. It has also been suggested that improving ventilation and managing exposure duration can reduce transmission.
The COVID-19 pandemic has affected animals directly and indirectly. SARS-CoV-2, the virus that causes COVID-19, is zoonotic, which likely to have originated from animals such as bats and pangolins. Human impact on wildlife and animal habitats may be causing such spillover events to become much more likely. The largest incident to date was the 2020 Danish mink cull, the slaughter of all 17 million mink in Denmark after it was discovered that they were infected with a mutant strain of the virus.
The Beta variant, (B.1.351), was a variant of SARS-CoV-2, the virus that causes COVID-19. One of several SARS-CoV-2 variants initially believed to be of particular importance, it was first detected in the Nelson Mandela Bay metropolitan area of the Eastern Cape province of South Africa in October 2020, which was reported by the country's health department on 18 December 2020. Phylogeographic analysis suggests this variant emerged in the Nelson Mandela Bay area in July or August 2020.
COVID-19 vaccination in Kazakhstan is an ongoing immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country.
COVID-19 rapid antigen tests or RATs, also frequently called COVID-19 lateral flow tests or LFTs, are rapid antigen tests used to detect SARS-CoV-2 infection (COVID-19). They are quick to implement with minimal training, cost a fraction of other forms of COVID-19 testing, and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches. Many RATs can be used for self-testing, in which an individual "collects their own specimen… and interpret[s] their test result themselves".
Seegene, Inc is a Korean manufacturer of in vitro diagnostic (IVD) products, particularly molecular diagnostics. Its portfolio includes a range of assays and screening products for sepsis, respiratory diseases such as influenza and respiratory syncytial virus, as well as sexually transmitted infections (STIs). It was founded in 2000. In early 2020, it began developing and distributing a range of tests for SARS-CoV-2, the virus that causes COVID-19.
The United Kingdom's response to the COVID-19 pandemic consists of various measures by the healthcare community, the British and devolved governments, the military and the research sector.
Smell as evidence of disease has been long used, dating back to Hippocrates around 400 years BCE. It is still employed with a focus on volatile organic compounds (VOCs) found in body odor. VOCs are carbon-based molecular groups having a low molecular weight, secreted during cells' metabolic processes. Their profiles may be altered by diseases such as cancer, metabolic disorders, genetic disorders, infections, and among others. Abnormal changes in VOC composition can be identified through equipment such as gas chromatography-mass spectrometry(GC-MS), electronic nose (e-noses), and trained non-human olfaction.
The Wyss Institute for Biologically Inspired Engineering is a cross-disciplinary research institute at Harvard University focused on bridging the gap between academia and industry by drawing inspiration from nature's design principles to solve challenges in health care and the environment. It is focused on the field of biologically inspired engineering to be distinct from bioengineering and biomedical engineering. The institute also has a focus on applications, intellectual property generation, and commercialization.