A coronavirus breathalyzer is a diagnostic medical device enabling the user to
test
Test(s), testing, or TEST may refer to:
* Test (assessment), an educational assessment intended to measure the respondents' knowledge or other abilities
Arts and entertainment
* ''Test'' (2013 film), an American film
* ''Test'' (2014 film), ...
with 90% or greater accuracy the presence of
severe acute respiratory syndrome coronavirus 2
Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a No ...
in an exhaled breath.
[Anthes, E.]
"A Covid Test as Easy as Breathing"
The New York Times
''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid ...
, July 11, 2021.
As of the first half of 2020, the idea of a practical coronavirus
breathalyzer
A breathalyzer or breathalyser (a portmanteau of ''breath'' and ''analyzer/analyser'') is a device for estimating blood alcohol content (BAC), or to detect viruses or diseases from a breath sample.
The name is a genericized trademark of the Br ...
was concomitantly developed by unrelated research groups in Australia, Canada, Finland, Germany, Indonesia, Israel, Netherlands, Poland, Singapore, United Kingdom and USA.
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.
Australia
In Australia, GreyScan CEO Samantha Ollerton and Prof. Michael Breadmore of the
University of Tasmania
The University of Tasmania (UTAS) is a public research university, primarily located in Tasmania, Australia. Founded in 1890, it is Australia's fourth oldest university. Christ College, one of the university's residential colleges, first pro ...
are basing a coronavirus breathalyzer on existing technology that is used around the world to detect explosives.
Canada
Canary Health Technologies, headquartered in
Toronto
Toronto ( ; or ) is the capital city of the Canadian province of Ontario. With a recorded population of 2,794,356 in 2021, it is the most populous city in Canada and the fourth most populous city in North America. The city is the ancho ...
with offices in
Cleveland
Cleveland ( ), officially the City of Cleveland, is a city in the U.S. state of Ohio and the county seat of Cuyahoga County. Located in the northeastern part of the state, it is situated along the southern shore of Lake Erie, across the U.S. ...
, 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.
Finland
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
Kazakhstan, officially the Republic of Kazakhstan, is a transcontinental country located mainly in Central Asia and partly in Eastern Europe. It borders Russia to the north and west, China to the east, Kyrgyzstan to the southeast, Uzbeki ...
, with plans to expand to the
Netherlands
)
, anthem = ( en, "William of Nassau")
, image_map =
, map_caption =
, subdivision_type = Sovereign state
, subdivision_name = Kingdom of the Netherlands
, established_title = Before independence
, established_date = Spanish Netherl ...
, the
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...
,
South Africa
South Africa, officially the Republic of South Africa (RSA), is the southernmost country in Africa. It is bounded to the south by of coastline that stretch along the South Atlantic and Indian Oceans; to the north by the neighbouring countri ...
,
Brazil
Brazil ( pt, Brasil; ), officially the Federative Republic of Brazil (Portuguese: ), is the largest country in both South America and Latin America. At and with over 217 million people, Brazil is the world's fifth-largest country by area ...
and
Finland
Finland ( fi, Suomi ; sv, Finland ), officially the Republic of Finland (; ), is a Nordic country in Northern Europe. It shares land borders with Sweden to the northwest, Norway to the north, and Russia to the east, with the Gulf of B ...
throughout the summer. The efficacy of the Forum Virium Helsinki / Deep Sensing Algorithms device hinges on its
AI component.
[Anon]
"Helsinki to trial coronavirus breathalyser"
Yle
Yleisradio Oy ( Finnish, literally "General Radio Ltd." or "General Broadcast Ltd."; abbr. Yle ; sv, Rundradion Ab, italics=no), translated to English as the Finnish Broadcasting Company, is Finland's national public broadcasting company, found ...
, June 29, 2020. "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.
Germany
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
In physics, terahertz time-domain spectroscopy (THz-TDS) is a spectroscopic technique in which the properties of matter are probed with short pulses of terahertz radiation. The generation and detection scheme is sensitive to the sample's effect on ...
. 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.
Indonesia
Since April 2020, a team of researchers from
Gadjah Mada University
Gadjah Mada University ( jv, ꦈꦤꦶꦥ꦳ꦼꦂꦱꦶꦠꦱ꧀ꦓꦗꦃꦩꦢ; id, Universitas Gadjah Mada, abbreviated as UGM) is a Public university, public research university located in Sleman Regency, Sleman, Yogyakarta (special region) ...
(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
Yogyakarta (; jv, ꦔꦪꦺꦴꦒꦾꦏꦂꦠ ; pey, Jogjakarta) is the capital city of Special Region of Yogyakarta in Indonesia, in the south-central part of the island of Java. As the only Indonesian royal city still ruled by a monarchy, ...
. 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.
Israel
In Israel, it is at the photonics lab of Gabby Sarusi, professor at
Ben-Gurion University of the Negev
Ben-Gurion University of the Negev (BGU) ( he, אוניברסיטת בן-גוריון בנגב, ''Universitat Ben-Guriyon baNegev'') is a public research university in Beersheba, Israel. Ben-Gurion University of the Negev has five campuses: the ...
, 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
Chaim Sheba Medical Center at Tel HaShomer ( he, המרכז הרפואי ע"ש חיים שיבא – תל השומר), also Tel HaShomer Hospital, is the largest hospital in Israel, located in the Tel Aviv District city of Ramat Gan at Tel HaShome ...
had devised a breathalyzer that
Magen David Adom
The Magen David Adom ( he, מגן דוד אדום, abbr. MDA, pronounced ''MAH-dah'' per its Hebrew acronym, ) is Israel's national emergency medical, disaster, ambulance and blood bank service. The name means "Red Shield" or "Red Star of Davi ...
(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.
The Netherlands
A breath test with the
SpiroNose device, made by the Dutch company Breathomix,
has been developed and tested in collaboration with the
Leiden University
Leiden University (abbreviated as ''LEI''; nl, Universiteit Leiden) is a Public university, public research university in Leiden, Netherlands. The university was founded as a Protestant university in 1575 by William the Silent, William, Prince o ...
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
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...
. From April 2021, the device was operational in COVID-19 test drive-ins, conferences and events, i.e.
Eurovision Song Contest 2021
The Eurovision Song Contest 2021 was the 65th edition of the Eurovision Song Contest. It took place in Rotterdam, Netherlands, following the country's win at the with the song "Arcade" by Duncan Laurence. The Netherlands was set to host the , ...
. Subjects must abstain from alcohol for eight hours prior to taking the breath test.
The SpiroNose contains four sets of seven different
sensor
A sensor is a device that produces an output signal for the purpose of sensing a physical phenomenon.
In the broadest definition, a sensor is a device, module, machine, or subsystem that detects events or changes in its environment and sends ...
s that can measure the mixture of
volatile organic compound
Volatile organic compounds (VOCs) are organic compounds that have a high vapour pressure at room temperature. High vapor pressure correlates with a low boiling point, which relates to the number of the sample's molecules in the surrounding air, a ...
s (
biomarker
In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, ...
s) 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
Signal processing is an electrical engineering subfield that focuses on analyzing, modifying and synthesizing ''signals'', such as audio signal processing, sound, image processing, images, and scientific measurements. Signal processing techniq ...
and statistics based on independent
t-test
A ''t''-test is any statistical hypothesis testing, statistical hypothesis test in which the test statistic follows a Student's t-distribution, Student's ''t''-distribution under the null hypothesis. It is most commonly applied when the test stati ...
s followed by
linear discriminant and
ROC analysis
A receiver operating characteristic curve, or ROC curve, is a graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied. The method was originally developed for operators of ...
. 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
The polymerase chain reaction (PCR) is a method widely used to rapidly make millions to billions of copies (complete or partial) of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it (or a part of it) t ...
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 Public health surveillance (also epidemiological surveillance, clinical surveillance or syndromic surveillance) is, according to the World Health Organization (WHO), "the continuous, systematic collection, analysis and interpretation of health-relat ...
, source and
contact tracing
In public health, contact tracing is the process of identifying persons who may have been exposed to an infected person ("contacts") and subsequent collection of further data to assess transmission. By tracing the contacts of infected individua ...
, 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. 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.
The analysis platform is developed conform the requirements of the standard
ISO 27001
ISO is the most common abbreviation for the International Organization for Standardization.
ISO or Iso may also refer to: Business and finance
* Iso (supermarket), a chain of Danish supermarkets incorporated into the SuperBest chain in 2007
* Iso ...
(Information Security) and NEN 7510 (Information Security in Health Care).
A
CE marking
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificatio ...
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 disease
Interstitial lung disease (ILD), or diffuse parenchymal lung disease (DPLD), is a group of respiratory diseases affecting the interstitium (the tissue and space around the alveoli (air sacs)) of the lungs. It concerns alveolar epithelium, pulmo ...
s (ILD).
Poland
![COVID Detector](https://upload.wikimedia.org/wikipedia/commons/2/2c/COVID_Detector.jpg)
In February 2021, the
President of Poland
The president of Poland ( pl, Prezydent RP), officially the president of the Republic of Poland ( pl, Prezydent Rzeczypospolitej Polskiej), is the head of state of Poland. Their rights and obligations are determined in the Constitution of Polan ...
,
Andrzej Duda
Andrzej Sebastian Duda (; born 16 May 1972) is a Polish lawyer and politician who has served as president of Poland since 6 August 2015. Before becoming president, Andrzej Duda was a member of Polish Lower House (Sejm) from 2011 to 2014 and the ...
, announced that ML System S. A., headquartered in
Zaczernie
Zaczernie is a village in the administrative district of Gmina Trzebownisko, within Rzeszów County, Subcarpathian Voivodeship, in south-eastern Poland. It lies approximately north-west of Trzebownisko and north of the regional capital Rzeszó ...
,
Poland
Poland, officially the Republic of Poland, is a country in Central Europe. It is divided into 16 administrative provinces called voivodeships, covering an area of . Poland has a population of over 38 million and is the fifth-most populous ...
, 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
Rzeszów–Jasionka Airport is an international airport located in southeastern Poland, in Jasionka, a village from the center of the city of Rzeszów. It is the eighth-busiest airport in Poland.
History
Passenger domestic services to Rzesz ...
published a statement indicating their intention to test the device at the airport. Similar plans exist between the manufacturer and the
Warsaw Chopin Airport
Warsaw Chopin Airport ( pl, Lotnisko Chopina w Warszawie, ) is an international airport in the Włochy district of Warsaw, Poland. It is Poland's busiest airport with 18.9 million passengers in 2019, thus handling approximately 40% of th ...
. 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.
United Kingdom
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.
United States
In June 2020, American researchers at
UCLA
The University of California, Los Angeles (UCLA) is a public land-grant research university in Los Angeles, California. UCLA's academic roots were established in 1881 as a teachers college then known as the southern branch of the California St ...
and
Ohio State University
The Ohio State University, commonly called Ohio State or OSU, is a public land-grant research university in Columbus, Ohio. A member of the University System of Ohio, it has been ranked by major institutional rankings among the best publ ...
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 from 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
The UCLA Henry Samueli School of Engineering and Applied Science, informally known as UCLA Samueli School of Engineering or UCLA Engineering, is the school of engineering at the University of California, Los Angeles (UCLA). It opened as the Colle ...
, whose research team received a one-year, $150,000 research grant from the
National Science Foundation
The National Science Foundation (NSF) is an independent agency of the United States government that supports fundamental research and education in all the non-medical fields of science and engineering. Its medical counterpart is the National I ...
.
Commercial Research Developments
In July 2019, 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 it 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 of Volatile Organic Compounds (VOCs) a.k.a. smell associated with the metabolism of COVID-19 infection in a human or non-human. The team went on to tune their associated AI algorithms to achieve an almost faultless 100% detection accuracy in 5 seconds. The company was granted the first real-time Covid detection patent on 29 Dec 2020, U.S. Patent number US 10,880,303 Real-time COVID-19 outbreak identification with non-invasive, internal imaging for dual biometric authentication and biometric health monitoring its fourth patent issued in two years, on March 15, 2022, they were granted U.S. Patent number 11,277,405 Dual biometric authentication and biometric health monitoring using chemosensory and internal imaging data.
In April 2022, the
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
authorized for emergency use the first COVID-19 diagnostic test using breath samples.
"The InspectIR COVID-19 Breathalyzer uses a technique called
gas chromatography
Gas chromatography (GC) is a common type of chromatography used in analytical chemistry for separating and analyzing compounds that can be vaporized without decomposition. Typical uses of GC include testing the purity of a particular substance, ...
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.
References
External links
COVID-19 Diagnostics & testing of FINDSpiroNose
{{COVID-19 pandemic
Applications of artificial intelligence
Biomarkers
Biosensors
Breath tests
Breathalyzer
COVID-19 testing
Medical tests