FDA Authorizes First Rapid COVID-19 At-Home Test

[J.Adderton, BSN, MSN]

Need to be tested for COVID-19?  Chances are you’re name will go on a waiting list or you’ll wait for testing in a crowded waiting room.  Wouldn’t it be great if we could test in the comfort of our own home and get the results in real time?  Good news!  The FDA has recently authorized the first rapid at-home test, the Lucira COVID-19 All-In-One Test Kit.

How does the test work?

The test uses reverse transcription loop-mediated isothermal amplification technology(RT-LAMP) .  Sounds complicated, right?  In simpler terms....the test detects the novel coronavirus SARS-CoV-2 that causes COVID-19.  Because this is a molecular test, the risk of false negative results are greatly reduced.

How is the test administered?

The all-in-one kit is for single use only and a nasal swab is used to collect the test sample.

What comes in the Lucira COVID-19 All-In-One Test Kit?

The kit contains everything needed to perform a single test.  Including:

• Instructions
• 1 test unit
• 1 sample vial
• 1 sterile nasal swab
• 2 AA batteries
• 1 disposal bag

How much does the test cost and when will it be available?

The Lucira test is expected to cost around $50.  The first tests will be rolled out to patients served by Sutter Health in Norther California and Cleveland Clinic Florida, in the Miami area.  It is expected to be available throughout the U.S. by early Spring 2021 and will require a prescription from your healthcare provider.

Lucira hopes to amend its emergency use authorization by the second quarter of 2021 so people can consult with a physician online for the prescription.  The test can then be shipped directly to patient homes. 

How long will it take to get the test results?

The testing process takes up to 30 minutes, but a positive test can result in as little as 11 minutes.  Results are reported back to the prescriber's office so data can be tracked and reported to state health departments.

How did Lucira validate the test for accuracy?

Lucira conducted a study of more than 100 people from a wide range of ages, ethnicities and education levels.  Patient suspected of having COVID-19 tested themselves outside of their homes and were observed by trained professionals.  Here are a few key study findings:

• The trial reported 100% of study participants were able to successful run the test.
• When compared to one of the most reliable FDA authorized high sensitivity SARSCoV-2 assays available, Lucira’s home test positive tests agreed 94.1% of the time across all samples.  
• The positive tests agreed 100% of the time when samples containing very low levels of the virus were excluded.
• The negative results agreed 98.0% of the time across all samples

Lucira continues clinical trials at the Cleveland Clinic Florida.

In a November 18th media release, Dr. James Roach, a Principle Investigator on Lucira’s Cleveland Clinic Florida Trial, states

Quote

“Immediate, on-site testing will improve patient care and throughput in urgent care environments. This test will allow patients to isolate at home while waiting for results with faster turnaround.” 

What if the test results are negative?

It is possible for this test to result in a false negative in some people who have COVID-19.  Your healthcare provider will consider what symptoms you are having and if you’ve possibly been exposed when deciding how to treat you if the test is negative.  

The Lucira COVID-19 All-In-One Test Kit may not be accurate if you test too early or too late during a COVID-19 infection.

Does the test have age recommendations?

The test may be prescribed for home use to people age 14 years or older.  For children under 14, the test may be prescribed.. but will need to be administered by a healthcare professional.

Are there any associated risks?

Swabbing your nose can cause nasal discomfort.  There is also the risk of incorrect test results, which could lead to misdiagnosis or unnecessary treatment.  

What Do You Think?

Would you try at-home rapid testing?  Are you concerned about any drawbacks?

Lucira package insert

Fact Sheet for Healthcare Providers

FDA Press Release

[SummitRN, BSN, RN]

I have low confidence in the ability of many people to reliably collect and test at home.

However, I do want my very own LAMP analyzer for my house.

[JVBT, ASN]

I've been wanting rapid easy testing since I first heard Michael Mina. But the big media interests and who knows who all else poo poohed it, so it hasn't happened. I've paid for my own covid test, early on, but now that I know a bit more, I doubt I'll pay any more (not over $20 at least). Bring the rapid tests - if a rapid test is positive, get a PCR.

[BSN-to-MSN, ADN, BSN, RN]

Nope, would not try.

[toomuchbaloney]

How does this facilitate contact tracing?