FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples with results in less than three minutes
As COVID-19 variants continue to emerge, the virus continues to wreak new havoc on society, although it may be quieter and more subtle than before. The new variant molecules are smaller and lighter in weight than the Alpha strain, meaning they can travel farther and remain suspended in the air longer than the original virus.
The variants are determined by the mutations in the viral spike proteins. In some ways the variants are not as threatening now as the Alpha was, but they are more contagious. The spike proteins continue to cause long term temporary or permanent damage in a percentage of the population, resulting in Long COVID (PASC). We can see the impact in our Facebook COVID-19 Long Haulers Support community, with an average 1000-1500 new members joining weekly, seeking education on recovery and resources. So while society has made strides in returning to normalcy, the virus is still a threat to some. We cannot predict who will develop long COVID, so it is important that we remain diligent in keeping ourselves and our families safe through avoiding crowded places with poor ventilation, hand washing, and covering the face and mouth when coughing and sneezing.
Thankfully scientists have continued to research and develop new ways to detect and treat COVID-19. Several countries have announced a new breath test that can detect COVID-19 in minutes. This advancement is important in many ways including:
Safety for lab workers
Accuracy in diagnosis, including lower rates of false negatives
Simplicity in testing without risk of injury to nasal passages
Immediate diagnosis which will lead to early treatment interventions and prevention of spread
Reduction in costs associated with collecting, storing, transporting and processing nasal swab samples
FDA ANNOUNCEMENT
On April 14, 2022, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage. The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes.
The performance of the InspectIR COVID-19 Breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test was shown to have 91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified). The study also showed that, in a population with only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence. The test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant.
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. When the InspectIR COVID-19 Breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, as they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.
FDA Consumer Contact: 888-INFO-FDA
Read the full announcement at Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples | FDA
Resources from covidCAREgroup
Recovery Tools — covidCAREgroup
Education Blog Table of Contents — covidCAREgroup
Long COVID Recovery Information and Resources — covidCAREgroup
Long COVID FAQ — covidCAREgroup
COVID-19 Long Haulers Support Group (Facebook)
Keep moving, keep breathing.
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Blog Author/Researcher: Delainne Bond, BSN, RN