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FDA has authorized a breath-based diagnostic test to detect the chemical components in breath samples related to coronavirus infection in just 3 minutes.
On 14 April 2022, the Food and Drug Administration (FDA) granted an emergency use authorization for a novel diagnostic test (InspectIR COVID-19 Breathalyzer) that can easily and rapidly detect SARS-CoV-2 infection in the breath. It exhibits certain remarkable features as depicted below:
When the breathalyzer test detects the presence of volatile organic compounds markers of SARS-CoV-2, a presumptive/unconfirmed positive finding is returned and needs to be validated using a molecular test. The negative outcomes must be taken into consideration with respect to the patient’s recent exposures, past history and the presence of signs and symptoms consistent with coronavirus disease, as they do not rule out viral infection and must not be utilized as the sole basis for therapy or patient management decisions, including decisions for infection alleviation.
In an analysis of 2,409 people, including those without and with symptoms, validation of the performance of the test was done. The test exhibited 99.3% specificity (proportion of negative samples accurately detected) and 91.2% sensitivity ( proportion of positive samples accurately detected). Furthermore, in a population with only 4.2% of people who were positive for SARS-CoV-2, the test exhibited a negative predictive value of 99.6%.
This implied that individuals who receive a negative test result are probably truly negative in regions where there is a low prevalence of the disease. In a follow-up assessment that concentrated on the omicron variants, the breath-based diagnostic test performed with the same sensitivity. The testing capacity utilizing this novel diagnostic test is anticipated to rise by about 64,000 samples/month.
US-FDA
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
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