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FDA approves first coronavirus home test that does not have to be sent to the laboratory | The State

Regulators of the United States Food and Drug Administration (FDA) passed a home test that is capable of detecting coronavirus in 30 minutes, but the exam must be approved by prescription.

Lucira Health’s diagnostic kit allows users to insert a swab into the nose that is then dipped into a laboratory solution that connects to a portable device, which, similar to pregnancy tests, marks the negative and positive result.

Requires a prescription

However, the FDA approved the test Tuesday for emergencies and not for everyone who wants to get one. The exam will require a prescription to limit its use in the initial phase.

So far, the FDA has authorized about 300 tests to detect coronavirus. Most of these involve the participation of a health professional and the sample has to be processed in laboratories with high-tech equipment.

Although there are tests that allow people to collect the sample at home through a runny nose or saliva, the material must be sent to a laboratory for the result, a process that could take several days.

Indeed, the Lucira Health home test would break this pattern.

Part of the advantages of these types of exams is that they prevent people from having to leave their homes; this reduces time and risks of contagion.

“This new testing option is an important diagnostic advancement in addressing the pandemic and reducing the public burden of disease transmission,” FDA Commissioner Stephen M. Hahn said in a news release.

“Today’s action highlights the FDA’s continued commitment to expanding access to COVID-19 testing,” the official said.

Additionally, rapid tests promote immediate quarantine, which in turn implies a lower level of spread of the virus.

A bigger challenge

The challenge for health authorities is that users of these tests report the results.

If the results are not reported back, it will be difficult to know what is happening in the community in general, according to experts on the subject.

The FDA added that the Lucira test may also be performed in doctors’ offices and testing centers. At the moment, the spaces in the US that perform the tests must report the results to state and federal authorities. Doctors are required to report the results of home tests.


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