The US Food and Drug Administration (FDA) on April 14 granted an emergency use authorization for the first Covid-19 breath test kit.
The test kit is named InspectIR, the size of a piece of hand luggage, results in less than three minutes. The device can be used in clinics, hospitals, and mobile, manned testing sites. One machine tests about 160 samples per day.
“The licensing decision is an example of rapid innovation for diagnostic tests for Covid-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
The device was tested in a study of 2,400 asymptomatic people with Covid-19. According to scientists, the machine correctly identifies 91% of positive samples and 99% of negative samples. Patients with positive results should be reconfirmed by molecular testing, such as PCR.
The FDA warned that it is necessary to further consider negative results in close contacts of patients with clinical symptoms of Covid-19 to increase accuracy. The agency also notes that the device should not be used “as the sole basis for patient diagnosis and treatment, including infection control decisions”.
Expanding testing options is a stepping stone to helping the community transition to Covid-19 as an endemic disease, according to Yvonne Maldonado, an infectious disease expert at Stanford University School of Medicine.
“If you think back to the PCR tests at the beginning of the epidemic, they were pretty horrible, frustrating and time-consuming. Everything is easier now,” Ms. Maldonado said.
The company expects to be able to produce 100 breathalyzers per week.
Image of InspectIR testing machine approved by FDA on April 14. Image: CBS news
Thuc Linh (According to NY Times)
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