Covid-19 Breathalyzer test: What do you need to know?
- FDA Authorized first InspectIR’s Covid-19 Breathalyzer.
- BA.2 variant causes an uptick in the USA.
- Pfizer and BioNTech plan to ask the FDA for EUA of Booster dose for the 5 to 11 age group.
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Are you ready for a new era in medical testing? The U.S. Food and Drug Administration (FDA) Yesterday (April 14, 2022) approved a revolutionary new test that will identify Severe acute respiratory syndrome (SARS)-CoV infections in less than three minutes.
“Breathe, it’s just a bad day, not a bad life.” – Author Unknown.
“Breath is the link between mind and body.” – Dan Brule, similar to Dan Brule’s quote, The FDA has approved the first COVID-19 diagnostic test using breath samples, which detects chemical compounds in SARS-CoV-2-infected breath.
InspectIR’s Covid-19 Breathalyzer is a rapid, accurate, and noninvasive test that can give results in less than three minutes, and it’s about the size of a piece of carry-on luggage, so it can be used in doctor’s medical offices, hospitals, and mobile testing sites!
The InspectIR COVID-19 Breathalyzer will be available for testing only “by a qualified, trained operator under the supervision of a health care provider,” according to the FDA.
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said, “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” and he added that “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”
Who is InspectIR?
What is InspectIR COVID-19 Breathalyzer?
The test is carried out by inhaling into a tube in a similar way to blowing up a balloon, according to InspectIR. The InspectIR COVID-19 Breathalyzer utilizes a technique called gas chromatography gas mass spectrometry (GC-MS) to isolate and identify chemical mixtures and quickly detect five VOCs linked with SARS-CoV-2 infection in exhaled breath.
If the InspectIR Covid-19 Breathalyzer detects SARS-CoV-2 VOC markers, a positive test result is returned, which should be validated with a PCR test.
Negative results should be interpreted in view of a patient’s recent exposures, medical history, and the existence of clinical signs and symptoms consistent with COVID-19.
How does the InspectIR Covid-19 Breathalyzer works?
According to the details given on InspectIR’s website, InspectIR covid-19 breathalyzer follows 4 steps to get the results within 3 minutes.
1. The individual exhales through their mouth into a tube connected to the test kit, similar to blowing up a balloon.
2. The chemistry in a person’s breath as captured by the patened InspectIR systems device.
3. Patented measurement process runs, allowing for the identification and quantification of covid-19 markers as well as spectrometry.
4. Using proprietary software, the InspectIR systems device analyses and displays results.
How accurate are the test results of the InspectIR COVID-19 Breathalyzer?
An extensive study of 2,409 people, including those with and without symptoms, was used to validate the performance of the InspectIR COVID-19 Breathalyzer.
The device was 91.2 % accurate at recognizing positive test samples and 99.3% accurate at identifying negative test results, according to the FDA.
A follow-up clinical research focused on the omicron version found that the test had equal sensitivity.
How many tests will be diagnosed with InspectIR in a day?
InspectIR is capable of evaluating around 160 samples per day.
InspectIR aims to be able to create around 100 instruments per week, so the testing capacity for the InspectIR COVID-19 Breathalyzer is estimated to rise by roughly 64,000 samples per month at this quantity of production.
BA.2 variant causes an uptick in the USA
The largest uptick of cases with the BA.2 omicron subvariant in the United States. According to the Centers for Disease Control and Prevention, BA.2 is responsible for roughly 86% of cases in the United States.
However, the picture varies from state to state. Cases are increasing in 25 states, decreasing in 16, and remaining stable in nine others.
Each day, there are slightly more than 500 deaths. Doctors hope that increasing access to treatments, such as monoclonal antibodies and antiviral medications for the most vulnerable, will prevent an increase in Covid-related hospitalizations and deaths.
BA.2 is wreaking havoc in the Northeast, where virus levels in wastewater are rising along with reports of infections in cities like New York, Washington, D.C., and Philadelphia. Concerns about BA.2 prompted Philadelphia to reinstate an indoor mask rule, and CDC expands this week, mask requirements in public transportation until May 3.
New York City had been rethinking its mask necessities for preschoolers, but with cases increasing in the city, Mayor Eric Adams recently stated that masks would continue to be required for the city’s youngest children, who had higher rates of hospitalization during Omicron than in previous waves.
Several universities in the United States, including Columbia, American, Georgetown, George Washington, Johns Hopkins, and Rice, have reinstated mask mandates.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases said, “We are certainly seeing the beginning of a surge of new infections,” and he added, “I can’t say where we are right now, because we’re transitioning.”
Pfizer and BioNTech plan to ask the FDA for EUA of Booster dose for the 5 to 11 age group.
Pfizer and BioNTech plan to ask the FDA to approve the third dose of their COVID-19 vaccine for children aged 5 to 11, the vaccine manufacturers announced Thursday, citing trial results that show a “robust response” of antibodies in this age group after the booster shot.
In children aged 5 to 11, the third dose of Pfizer/Covid-19 BioNTech’s vaccine increased Omicron-fighting antibodies by 36 times, the companies said.
The new findings are based on a small study of 140 children aged 5 to 11 who received a third 10-microgram dose of the Pfizer-BioNTech Covid-19 vaccine at least six months after their first dose.
The researchers examined antibody levels in serum (the clear part of the blood) from a subset of 30 children in this group one month after their third shot and discovered that antibodies against the Omicron variant were 36 times higher than after the second dose of the vaccine.
Antibody levels against the original strain of the SARS-CoV-2 virus were six times higher one month after a booster dose than one month after the second vaccine dose in a study of 140 children with no evidence of prior Covid-19 infection.
According to research from the New York State Department of Health and the US Centers for Disease Control and Prevention, the effectiveness of Pfizer’s vaccine for children aged 5 to 12 dropped significantly during the Omicron surge, falling from 68 percent to around 12 percent against Covid-19 infection.
Two doses of the vaccine, on the other hand, continued to provide protection against more severe illnesses that required urgent care or hospitalization.
Last month, Dr. Peter Marks, the FDA’s top vaccine official, told reporters, “We at FDA really understand the urgency that people feel about wanting to get the youngest children vaccinated. We also understand that this is the age range when people are most concerned about potential side effects and the potential safety of vaccines.”
According to a Pfizer spokesperson, data on three doses in children under the age of 5 will be available in the coming weeks.
Moderna has also released positive interim data from trials involving only two doses of its vaccine in children as young as six months old, with plans to seek FDA approval in the coming weeks.
Are all of your family members had their vaccine doses? Please recheck.
Stay Safe! Stay Healthy!