News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Breath Sample Is Used by Opteev Technologies’ Combined COVID/Influenza/RSV Screening Device with 95% Sensitivity and 90% Specificity

Clinical laboratories and point-of-care settings may have a new diagnostic test if this novel handheld device and related technology is validated by clinical trials

Efforts to develop breath analyzers that accurately identify viral infections, such as SARS-CoV-2 and Influenza, have been ongoing for years. The latest example is ViraWarn from Opteev Technologies in Baltimore, Maryland, and its success could lead to more follow-up PCR tests performed at clinical laboratories.

ViraWarn is a pocket-size breath analyzer that detects COVID-19, influenza, and respiratory syncytial virus (RSV) in about a minute, according to an Opteev news release. The technology company just submitted ViraWarn to the US Food and Drug Administration (FDA) for Pre-Emergency Use Authorization (Pre-EUA).

“Breath is one of the most appealing non-invasive sample types for diagnosis of infectious and non-infectious disease,” said Opteev in its FDA Pre-EUA application. “Exhaled breath is very easy to provide and is less prone to user errors. Breath contains a number of biomarkers associated with different ailments that include volatile organic compounds (VOCs), viruses, bacteria, antigens, and nucleic acid.”

Further clinical trials and the FDA Pre-EUA are needed before ViraWarn can be made available to consumers. In the meantime, Opteev announced that the CES (Consumer Electronic Show) had named ViraWarn as a 2023 Innovation Award Honoree in the digital health category. 

Conrad Bessemer

“ViraWarn is designed to allow users an ultra-fast and convenient way to know if they are spreading a dangerous respiratory virus. With a continued increase in COVID-19 and a new surge in RSV and influenza cases, we’re eager to bring ViraWarn to market so consumers can easily blow into a personal device and find out if they are positive or negative,” said Conrad Bessemer (above), Opteev President and Co-Founder, in a news release.

Opteev is a subsidiary of Novatec, a supplier of machinery and sensor technology, and a sister company to Prophecy Sensorlytics, a wearable sensors company. 

The ViraWarn breath analyzer uses a silk-based sensor that “traces the electric discharge of respiratory viruses coupled with an artificial intelligence (AI) processor to filter out any potential inaccuracies,” according to the news release.

Here is how the breath analyzer (mouthpiece, attached biosensor chamber, and attached printed circuit board chamber) is deployed by a user, according to the Opteev website:

  • The user turns on the device and an LED light indicates readiness.
  • The user blows twice into the mouthpiece.
  • A carbon filter stops bacteria and VOCs and allows virus particles to pass through.
  • As “charge carriers,” virus particles have a “cumulative charge.”
  • In a biosensor chamber, virus particles create a change in “electrical resistivity.”
  • Electrical data are forwarded to the AI processor.
  • The AI processer delivers a result.
  • Within 60 seconds, a red signal indicates a positive presence of a virus and a green signal indicates negative one.

“The interaction of the virus with a specially designed liquid semiconductive medium, or a solid polymer semiconductor, generates changes in the conductivity of the electrical biosensor, which can then be picked up by electrodes. Such electrical data can be analyzed using algorithms and make a positive or negative call,” explains an Opteev white paper on the viral screening process.

While the ViraWarn breath analyzer can identify the presence of a virus, it cannot distinguish between specific viruses, the company noted. Therefore, a clinical laboratory PCR test is needed to confirm results.

Other Breath Tests

Opteev is not the only company developing diagnostic tests using breath samples.

In “Will Blowing in a Device Be Useful in Screening for COVID-19? FDA Grants Its First EUA for a Breathalyzer SARS-CoV-2 Screening Test,” Dark Daily reported on the FDA issuing an EUA in 2022 for the InspectIR COVID-19 Breathalyzer, the first test to detect compounds in breath samples linked to SARS-CoV-2 infection, an FDA statement noted.

And in “NIST Scientists Enhance Frequency Comb Breathalyzer Enabling It to Detect Multiple Disease Biomarkers,” we covered how researchers at JILA, a research center jointly operated by the National Institutes of Standards and Technology (NIST) and the University of Colorado Boulder, have developed a breath test that can detect and monitor four disease biomarkers at one time with the potential to identify six more.

For clinical laboratory managers and pathologists, Opteev’s ViraWarn is notable in breath diagnostics development because it is a personal hand-held tool. It empowers people to do self-tests and other disease screenings, all of which would need to be confirmed with medical laboratory testing in the case of positive results.

Further, it is important to understand that consumers are the primary target for this novel diagnostic device. This is consistent with investor-funding companies wanting to develop testing solutions that can be used by consumers. At the same time, a device like ViraWarn could be used by clinical laboratories in their patient service centers to provide rapid test results.  

Donna Marie Pocius

Related Information:

Pocket-Sized Breath Analyzer Detects COVID-19, RSV, Influenza in Under 60 Seconds

COVID-19, RSV, and Influenza Breath Analyzer, ViraWarn, Wins CES 2023 Innovation Award

Baltimore Company Launches Device That Detects COVID-19, Flu

ViraWarn Pre-EUA Application

The Missing Piece in the Fight Against the Pandemic is Finally Here: The Evolution of Screening for COVID-19

FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

Will Blowing in a Device Be Useful in Screening for COVID-19? FDA Grants Its First EUA for a Breathalyzer SARS-CoV-2 Screening Test

NIST Scientists Enhance Frequency Comb Breathalyzer Enabling It to Detect Multiple Disease Biomarkers

Study into Use of Breath Analysis to Monitor Lung Cancer Therapy Enhances Clinical Laboratories’ Ability to Support Precision Medicine

A recent study adds to the growing body of research into breath analysis as a diagnostic and treatment-monitoring tool

More progress is being made on the diagnosis and treatment of lung cancer. The newest developments will be of interest to anatomic pathologists who work with lung specimens. A new study suggests it is possible to use breath specimens to monitor the progress of lung cancer patients undergoing therapy.

The study was conducted by Inbar Nardi-Agmon, MD, Thoracic Cancer Research and Detection Center at Sheba Medical Center, Tel-Aviv, Israel, and colleagues, and was published in the Journal of Thoracic Oncology (JTO). The study investigated the use of breath analysis to monitor lung cancer therapy.

The authors of the study took 143 exhaled breath samples from 39 patients who were undergoing treatment for advanced lung cancer. They used gas chromatography and mass spectrometry analysis to identify three different volatile organic compounds (VOCs) that indicate partial response (PR) or stable disease. One of those compounds discriminated between PR/stable disease and progressive disease. (more…)

In the UK, Pathologists Are Watching Phase II of a Clinical Trial for a Breathalyzer System That Uses Only a Breath Specimen to Diagnose Lung Cancer

If the clinical study validates this patient-friendly, non-invasive approach to diagnosing lung cancer, it could eventually mean fewer referrals of tissue biopsies to medical laboratories

For almost a decade, pathologists have seen a regular stream of news stories about technologies that utilize a sample of human breath to diagnose a disease or health condition. Now comes news that just such a diagnostic test for lung cancer is beginning clinical trials in the United Kingdom.

The clinical trials will evaluate breathalyzer technology developed by Engineer Billy Boyle, M.S., Co-founder and President of Operations at Cambridge-based Owlstone Ltd.. The clinical trials of this new breathalyzer technology to detect lung cancer are taking place at two National Health Service (NHS) hospitals: University Hospitals of Leicester and Cambridge’s Papworth Hospital in the United Kingdom.

The reason why so much research is happening in this field will be familiar to clinical laboratory managers and pathologists. Use of volatile organic compound (VOC) biomarkers in breath to diagnose disease is an ideal concept because it is convenient, non-invasive, and well tolerated by patients. However, until the start of this clinical study, researchers have explored the potential of this diagnostic approach for some time, but with limited success. (more…)

In Clinical Trials, Breath Test for Lung Cancer Shows Promise for Earlier Detection

Pathologists may do fewer lung biopsies should non-invasive breath testing technology make it into clinical practice

Here’s a medical laboratory test for diagnosing cancer that has the potential to score two runs with one swing of the bat. First, researchers have completed the first clinical trial of a non-invasive cancer test that utilizes a breath specimen.

Second, the subject of this clinical trial was lung cancer—a type of cancer that would benefit from a pathology test that can detect the disease much earlier. This would increase the survival rates for lung cancer, which currently has a five-year mortality rate of 90%.

As many pathologists and clinical laboratory managers know, it is possible to use breath specimens to diagnose a variety of diseases and health conditions. For almost 20 years, breath samples have been used to test for Helicobacter pylori, the bacteria which causes ulcers in the stomach.
(more…)

;