FDA OKs Over-the-Counter COVID-19 Home Test

FDA OKs Over-the-Counter COVID-19 Home Test”

'Today's authorization is a major milestone in diagnostic testing for COVID-19, ' said FDA Commissioner Stephen Hahn.

The U.S. Food and Drug Administration (FDA) has authorized the first at-home coronavirus test that doesn't require a prescription.

The order, issued by health secretary Nitin Madan Kulkarni, also asked private laboratories to conduct the RT-PCR test on the symptomatic patients and allows them to charge extra Rs 200 above the Rs 800 fee to collect samples from the patients' home, if needed. Since it can be used on adults and children no younger than 2 years old, the swab comes with an additional adapter - so users can shorten the device's length when swabbing young people.

Ellume's test looks for viral proteins shed by Covid-19, which is different from the gold standard tests that look for the genetic material of the virus. "In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples".

Earlier, the FDA authorized other tests created to help people test themselves at home to avoid long and potentially-hazardous lines of unwell patients. The test connects to a digital app to help users interpret the results.

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Antigen tests are usually cheaper and return results faster, but they have a sensitivity that varies between 34% to 80%, according to the World Health Organization, meaning "half or more of COVID-19 infected patients might be missed by such tests". Previously, the agency authorized the first prescription COVID-19 test for home use, and the first non-prescription test system that allows people to take their own samples before sending it to a lab for analysis.

Results from these exams usually need to be confirmed with a molecular test, which are accurate about 95% or more of the time, the FDA says.

The agency, however, cautioned that like other antigen tests, a small percentage of results from the test may be false.

The kit includes a nasal swab, a chemical solution and a testing strip. The same action applies to people who test negative but are experiencing coronavirus-like symptoms.

The test, made by California-based Ellume, will sell for around US$30 (S$40) and the company plans to roll out three million units in January 2021, and millions more in subsequent months. A report describing the development and validation of this test has recently been published in the journal Science Advances.

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