Miami-Dade explores self-testing kits for Covid-19

 

By mid-January, Miami-Dade could gain another useful tool in battling the spread of Covid-19: at-home tests.

Commissioners last month directed Mayor Daniella Levine Cava’s administration to explore the possibility of using the Lucira Covid-19 All-In-One Test Kit or other similar tests, which residents can use for rapid results without leaving home.

A report on what staff determine, including a recommendation for whether to use the test, how much it would cost and where the money to pay for it would come from, is due Jan. 15.

“It is well worth closely examining additional kinds of Covid-19 testing the county can provide,” said Commissioner Danielle Cohen Higgins, the sponsor of the resolution directing the mayor’s office to look into the test. “The promotion and facilitation of this convenient mode of testing in a meaningful way provides an innovative solution in our battle against Covid-19.”

In November, the Food and Drug Administration (FDA) issued an emergency use authorization for the Lucira test, the first rapid-result Covid-19 test available for home use.

It works much like in-lab tests. A person swabs both nostrils with what looks like a long Q-tip, touching the inside walls of their nasal cavity while rotating the swab. They then swirl the swab in a vial, which is then placed into the test unit. In 30 minutes or less, the test unit will show the results.

To get a single-use test for home use, a person 14 or older must first get a prescription. For people 13 or younger, the test must be administered by a healthcare provider at a doctor’s office, clinic or other medical point of care.

Compared to the standard RT-PCR test doctors and clinics use to detect Covid-19 in patients now, the Lucira test correctly detected 94% of positive cases.

Lucira Health, based in Emeryville, CA, said in November that it planned to make the test available in Florida and California first and then throughout the US by spring 2021.

The cost: $50 per kit.

“This new testing option is an important diagnostic achievement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen Hahn said in a statement Nov. 17.

On Dec. 15, the same day Miami-Dade commissioners unanimously OK’d Ms. Cohen Higgins’ item, the FDA authorized the emergency use of a second at-home test by Ellume.

Unlike the Lucira test, the Ellume Covid-19 Home Test was cleared for use without a prescription – the first such test. The Australian manufacturer said the test, which it expects will be available in the first half of 2021 at around a $30 per kit, can produce results in about 15 minutes.

The test was found to be 96% accurate compared to the RT-PCR test.

Even cheaper, at just $25 a kit, is Chicago-based manufacturer Abbott Laboratories’ BinaxNow home test, which won an FDA emergency use authorization Dec. 16. However, the test will only be available to patients by prescription aged 15 or older after they fill out a symptom questionnaire.

Early comparisons to the RT-PCR test successfully detected about 92% of positive cases and confirmed 100% of negative cases.

Since the onset of the pandemic, the FDA has authorized more than 225 Covid-19 tests, including 25 tests for at-home collection and in-lab analysis. 

Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said the FDA “will continue to work with test developers to support the availability of more innovative testing options.”