The FDA approves EUA for breathalyzer testing for COVID-19
The FDA approves EUA for breathalyzer testing for COVID-19

The FDA approves EUA for breathalyzer testing for COVID-19

Photo: Monkhonkhamsao / Getty Images

Tests for COVID-19 have become all too common during the pandemic and usually rely on a nasal swab to detect the presence of the SARS-CoV-2 virus that causes the disease. However, the Food and Drug Administration has just granted an emergency use permit for the first ever breathalyzer test for the virus, which can be used in doctors’ offices, hospitals and mobile test sites.

It is unlikely that a consumer will be able to use the device himself, at least in the beginning. Its use will be in clinical settings where trained operators will perform the test using an instrument the size of a piece of hand luggage.

The test, called the InspectIR COVID-19 Breathalyzer, is performed under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests and may provide results in less than three minutes. according to the FDA.

WHAT IS THE EFFECT

Product performance was validated in a study of 2,409 individuals, including those with and without symptoms. In the study, the test was shown to have 91.2% sensitivity (the percentage of positive samples that the test correctly identified) and 99.3% specificity (the percentage of negative samples that the test correctly identified).

The study also showed that in a population with only 4.2% of the individuals positive for the virus, the test had a negative predictive value of 99.6%, which means that people who receive a negative test result are likely to be real negative in low-level areas. disease prevalence.

The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant.

A technique called gas chromatography gas mass spectrometry (GC-MS) is used to separate and identify chemical mixtures and to quickly detect five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection in exhalation. When the breathalyzer detects the presence of VOC markers, a putative, 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 exclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions, “according to the FDA.

InspectIR expects to be able to produce around 100 instruments per week, each of which can be used to evaluate around 160 samples per day. At this level of production, the total test capacity is expected to increase by about 64,000 samples per month.

THE BIGGER TREND

Testing has been considered as one of the mail tools used in the fight against COVID-19. The Biden Administration has set such a high priority on testing that the Department of Health and Human Services in November invested $ 650 million from the U.S. rescue plan to strengthen production capacity for rapid diagnostic testing through rapid point-of-care molecular testing.

Hospitals, acute care centers, pharmacies and other local healthcare environments use rapid molecular testing to diagnose COVID-19, screen patients before surgery without unnecessary delays, identify individuals who can benefit from COVID-19 therapies, and confirm test results at home.

To support access to this type of diagnostic test, HHS planned to use these funds to increase US domestic production capacity. The idea is that by strengthening the ability to produce the tests in the United States, dependence on overseas imports will be reduced, enabling the country to maintain robust long-term production throughout this year.

Apart from the vaccination campaign, which the administration and the scientific community believe is the best way to prevent the spread of COVID-19, rapid and frequent testing for the virus is seen as an important mitigation measure and has long been the focus of Biden White. House.

In July 2021, for example, HHS said it would invest more than $ 1.6 billion from the U.S. rescue plan to support testing and mitigation measures in “high-risk gatherings.” This aims to prevent the spread of COVID-19 and to detect and contain potential outbreaks.

Twitter: @JELagasse
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