2 yıl önce

US greenlights first Covid-19 breath test

Through InspectIR Covid-19 Breathalyzer, the test "can be performed in environments where the patient specimen is both collected and analysed, using an instrument about the size of a piece of carry-on luggage, US drug agency says.

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FDA says they carried out tests on over 2,400 people including those with and without symptoms.

The US Food and Drug Administration (FDA) has granted emergency use authorisation for the first ever Covid-19 diagnostic test using breath samples.

Through the InspectIR Covid-19 Breathalyzer, the test "can be performed in environments where the patient specimen is both collected and analysed, such as doctor's offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage," the drug agency said on Thursday in a statement.

"The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorised by state law to prescribe tests and can provide results in less than three minutes," it added.

Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said the authorisation is another example of the rapid innovation occurring with diagnostic tests for Covid-19.

"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 US for the next public health emergency," he said.

High accuracy on tests

The InspectIR Covid-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures.

FDA said that 2,409 individuals participated InspectIR Covid-19 Breathalyzer study including those with and without symptoms.

"In the study, the test was shown to have 91.2 percent sensitivity (the percent of positive samples the test correctly identified) and 99.3 percent specificity (the percent of negative samples the test correctly identified)," the statement said.

The FDA-led study noted that in a population with only 4.2 percent of individuals who are positive for the virus, the test had a negative predictive value of 99.6 percent which indicates that if their tests come negative they are highly likely negative.

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

SOURCE: AA