Home COVID-19 Tests: Availability, Accuracy, and How They Work

  • Home testing for COVID-19 can be more convenient than traveling to a lab or doctor’s office.
  • It can also help reduce the risk of transmitting or contracting the coronavirus while you’re undergoing testing.
  • In addition, more and faster testing will help us better control the spread of COVID-19.
  • Because of these facts, the Food and Drug Administration has granted emergency use authorization to several home testing kits.
  • The agency believes the benefits of home testing will be greater than any risk that the tests may be less accurate.

During the COVID-19 pandemic, the idea of testing for the coronavirus from the comfort of our own homes can be quite appealing.

Not only is it more convenient, but it also eliminates the risk of transmitting or contracting the virus when we’re out among other people.

In addition, according to Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner for external relations at the Food and Drug Administration (FDA), a key part of the battle against COVID-19 is the need for “more, more accurate, and faster testing.”

In response to this need, the FDA has issued what are known as emergency use authorizations (EUAs) for several home COVID-19 tests.

Even though the effectiveness of these tests hasn’t been fully established, Pitts said that because we’re in the middle of an emergency, the FDA has determined that the benefits of making these tests available outweigh any potential risk that they may not be as accurate as we would like.

How the tests work

Most currently available tests involve taking your own sample at home and then shipping the sample off to a lab for processing.

While there are slight variations among the test providers, the general process is that you’ll need a physician’s approval to obtain testing.

In most cases, if you don’t have a personal physician to order the test, the labs will allow you to take an online screening survey. The results of your survey are then reviewed by their own physician, and an order for testing is issued.

You’ll then need to make arrangements for how to pay for the test, whether that’s through your health insurance, a health savings account (HSA), a flexible savings account (FSA), credit card, or a special provision through your employer.

Once payment has been arranged, test kits are mailed to your home.

Upon receipt of your testing kit, you’ll follow the provided instructions and either take a saliva sample or a nasal swab, depending on what the particular lab uses.

You’ll then return your sample to the lab for testing, either by mail or at a drop-off location designated by the test provider.

Results are generally available online within a few days.

In addition, some labs may provide virtual support, either during sample collection or to discuss the results.

What happens in the lab?

Home tests for COVID-19 that are sent to a laboratory for analysis involve using nucleic acid amplification to detect the presence of the virus.

According to Dr. Daniel Rhoads, section head of microbiology at the Cleveland Clinic, viruses have genomes that are made up of nucleic acids.

One way to detect small amounts of viral nucleic acid in a specimen is to use specialized chemistry and equipment to make more of a very small portion of the virus’s genome, Rhoads said.

To do this, labs use an amplification method called polymerase chain reaction (PCR).

In this method, chemicals are used to double the nucleic acid each time the sample is warmed up and cooled down.

When these steps are performed repeatedly, it greatly increases the amount of nucleic acid until it finally reaches a detectable amount.

And when that happens, it can be inferred that the virus’s nucleic acid must have been present in the original sample.

It’s very important for people to follow home COVID-19 test instructions precisely, especially for sample collection and preparation, to help ensure the most accurate result. Getty Images

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How accurate are the home tests?

Home tests receive the same lab processing that any other sample would, like one that was taken by a medical professional.

Because of that, we know that this portion of the test should have the same accuracy as any other test.

The difference with home tests is that they use either nasal swabs or saliva to collect the sample.

In professional settings, sampling would be done via nasopharyngeal swabs, which are collected more deeply in the nasal cavity than nasal swabs.

“This method is high value,” Rhoads said. “It can be done quickly and in an outpatient setting. Of the quick and easy-to-collect specimen types, the NP (nasopharyngeal) swab collects the most virus.”

However, Rhoads said he believes that nasal swabs and saliva specimens can be adequate for testing.

“Many studies have been performed this year to compare these different specimen types and, if collected properly, these specimen types are valuable tools,” he said.

Sherry Dunbar, PhD, MBA, senior director of global scientific affairs at Luminex, said, “It is important to note that test accuracy may vary depending on the quality of the specimen collected and who is running the test.”

“It will be very important for people to follow the test instructions precisely, especially for sample collection and preparation guidelines,” she said.

Home tests are “likely to have lower sensitivity and specificity than lab-run tests,” Dunbar said.

Sensitivity and specificity refer to the likelihood that the test will generate false-positive or false-negative results.

“On the whole, they are a better option than not having these tests available at all, but because of the potential for lower overall accuracy, they still should be confirmed and require physician follow-up for appropriate medical direction,” she said.

Dunbar added that she urges people who take home tests to follow up with their healthcare provider regardless of the test’s outcome, especially if they have COVID-19 symptoms.CORONAVIRUS UPDATESStay on top of the COVID-19 pandemic

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Are there any at-home tests that don’t need to be sent to a lab?

A rapid home COVID-19 test that doesn’t require a sample to be sent to a lab has been been approved by the FDA and is expected to be available for purchase within the next few months. Getty Images

On Nov. 17, the FDA issued an EUA for the first COVID-19 diagnostic test. It can be used to provide rapid results without the need to send the sample to a lab.

The Lucira COVID-19 All-In-One Test KitTrusted Source is a single-use test.

To do the test, you take a sample with a nasal swab. You then stir the swab into a sample vial and a small, handheld device analyzes it. Results are available in 30 minutes.

Lucira states that the test’s ability to detect the virus is comparable to the results obtained in clinical settings.

The home test is for people 14 years and older. It will be available by prescription only.

Younger people can take the test, but the sample must be taken by a medical professional.

At the time of publication, this test isn’t available to the public for purchase but is expected to become available within the next few months.

Providers of home testing kits

The number of labs providing home testing kits is subject to change over time, but below are some labs that are currently making kits available.

Most labs aren’t filing insurance claims for their patients. You’ll need to check with your health insurance company whether you’ll be reimbursed for the cost of the test.

Pixel by Labcorp

  • Sampling method: nasal swab
  • Cost: $0 upfront if insured or uninsured using public funds; $119 out of pocket
  • Learn more here

Vault Health

  • Sampling method: saliva
  • Cost: $119 out of pocket; accepts HSA and FSA; check with your insurance whether it will reimburse the cost
  • Learn more here

Everlywell

  • Sampling method: nasal swab
  • Cost: $109 out of pocket; accepts HSA and FSA; check with your insurance whether it will reimburse the cost
  • Learn more here

Picture by Fulgent Genetics

  • Sampling method: nasal swab
  • Cost: $119 out of pocket; check with your insurance whether it will reimburse the cost
  • Learn more here

P23 Labs

  • Sampling method: saliva
  • Cost: $75 plus $13 shipping, or $99 with shipping included both ways; check with your insurance whether it will reimburse the cost
  • Learn more here

LetsGetChecked

  • Sampling method: nasal swab
  • Cost: $119 out of pocket; accepts HSA and FSA; check with your insurance whether it will reimburse the cost
  • Learn more here

Phosphorus Diagnostics

  • Sampling method: saliva
  • Cost: $108 test fee, $12 telehealth oversight fee, $30–$40 shipping; check with your insurance whether it will reimburse the cost
  • Learn more here

KPMAS

  • Sampling method: nasal swab
  • Cost: free to Kaiser Permanente members
  • Learn more here

Kroger

  • Sampling method: nasal swab
  • Cost: free when arranged by contracted employers
  • Learn more here

Quest Diagnostics

  • Sampling method: nasal swab
  • Cost: $119 test fee plus $9.30 physician fee; check with your insurance whether it will reimburse the cost
  • Learn more here

Binx Health

  • Sampling method: nasal swab
  • Cost: $99; check with your insurance whether it will reimburse the cost
  • Learn more here

Hims & Hers

  • Sampling method: saliva
  • Cost: $80 lab costs plus $50 shipping and $20 telehealth services; check with your insurance whether it will reimburse the cost
  • Learn more here

Vitagene

  • Sampling method: saliva
  • Cost: $129 out of pocket; accepts HSA and FSA; check with your insurance whether it will reimburse the cost
  • Learn more here

source: healthline.com

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