We asked an expert.

By Maggie Seaver
January 27, 2021
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Diagnostic testing for the coronavirus remains one of the primary ways to help prevent and trace the spread of infection. But for the average American who's just trying to stay safe and vigilant, the entire testing process—finding and getting to a nearby test site, scoring an open appointment, and receiving results quickly—isn't always smooth sailing. Things get even more complicated if you're showing symptoms.

To make screening for the coronavirus as convenient, available, and reliable as possible, dozens of companies have spent the last few months developing at-home testing kits that are as good as on-site tests at detecting the presence of the SARS-CoV-2 virus. For much of 2020, existing self-administered diagnostic tests were given priority allocation to frontline healthcare workers and sick patients, but multiple test kits are now available over-the-counter (OTC) or with a prescription for purchase by the general population, both individuals and organizations (universities, companies, sports leagues/teams). 

"As of January 20, the Food and Drug Administration website (FDA) listed Emergency Use Authorization for 39 COVID-19 tests with an at-home claim from 32 companies," says Heather Fehling, PhD, chief scientific officer, molecular diagnostics at Clinical Reference Laboratory. The Clinical Reference Laboratory (CRL) Rapid Response self-collection, saliva-based test was among those authorized last year by the FDA. "At-home/self-administered tests are intended to improve access to testing so as to curb the spread of COVID-19," she says. "If you're able to administer a test at home yourself, there's less chance of exposure." 

Before you add to cart, here's what else to know about self-administered, at-home coronavirus tests.

Fehling confirms that home tests are just as accurate as those facilitated by a medical provider—when done correctly, of course. Remember, no diagnostic test can be 100 percent accurate, and this holds true whether you're conducting it at home or a nurse is facilitating at the doctor's office. 

The FDA has stated, for example, that it worked with Laboratory Corporation of America's (LabCorp) for the Pixel by Labcorp test to ensure that "data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor's office, hospital or other testing site." 

All at-home tests given emergency use authorization by the FDA have been thoroughly vetted and meet the agency's strict safety and efficacy guidelines.

"It’s important to choose a test that is backed by a reputable lab with strong core values," Fehling says, adding that CRL, for example, has a long, reputable history in diagnostic testing since its founding in 1979. "Whichever test you choose, always make sure it has the proper FDA authorizations and processed by a CLIA-certified lab." One easy way to check is by a quick internet search, or by visiting the test maker's website directly. FDA authorization is a badge of honor to be boasted about, so if an FDA stamp of approval is not immediately visible or easy to find on the website literature or test kit box/packaging, be wary.

A number of large retailers, including Costco and Walmart have begun selling COVID-19 test kits. There's also one option, the saliva-based PCR test from DxTerity Diagnostics, available to buy on amazon.com ($110 for one or $1,000 for 10).

"Most at-home COVID-19 test makers like CRL also sell kits directly to consumers through their websites," Fehling says. "While the majority of tests are available for individual purchase, some companies are only focusing on supporting the commercial market, and some others are [still] ramping up production for eventual consumer availability." The at-home antigen test, Ellume, for example, is still pending availability while in production. 

For the majority of tests that don't require a prescription, you'll need to complete a brief questionnaire or online consultation to determine your eligibility to buy one. For example, you might be asked to provide your name and birthdate, whether you're showing symptoms, your potential exposure/risk factor, if you've been asked to get a test for work or travel, and so on.

Here are just a few FDA-authorized, at-home test options currently on the market:

BinaxNOW COVID-19 Ag Card

  • Antigen test
  • Prescription required
  • Nasal swab
  • Fully at-home, self-administered: Sample collected and processed with a trained telehealth expert to guide users through process
  • Estimated turnaround time: 15 minutes

CRL Rapid Response ($110)

  • RT-PCR test
  • No prescription needed; must complete questionnaire
  • Saliva sample
  • Mail to lab for testing
  • Estimated turnaround time: within 48 hours of receipt at lab

DxTerity ($110)

  • RT-PCR Test
  • No prescription needed; must complete questionnaire and online registration and authorization (included in kit)
  • Saliva sample
  • Mail to lab for testing
  • Estimated turnaround time: within 24–72 hours hours of receipt at lab

Ellume (estimated to be around $30; not yet available for purchase)

  • Antigen test
  • No prescription needed
  • Nasal swab
  • Fully at-home, self-administered: Sample collected and processed via analyzer connected to your smartphone via Bluetooth
  • Estimated turnaround time: 15 minutes 

Everlywell ($109)

  • RT-PCR Test
  • No prescription needed; must complete questionnaire
  • Nasal swab
  • Mail to lab for testing
  • Estimated turnaround time: within 72 hours of receipt at lab

LetsGetChecked ($119)

  • RT-PCR test
  • No prescription needed; must complete questionnaire (you won’t qualify for this test if you have severe symptoms)
  • Nasal swab
  • Mail to lab for testing
  • Estimated turnaround time: within 24–72 hours of receipt at lab

Lucira 

  • Molecular (real-time loop mediated amplification reaction) test
  • Prescription-only
  • Nasal swab
  • Fully at-home, self-administered
  • Estimated turnaround time: 30 minutes

Vault ($119)

  • RT-PCR test
  • No prescription needed; must complete questionnaire
  • Saliva sample (collected over Zoom with a Vault test supervisor for guidance)
  • Mail to lab for testing
  • Estimated turnaround time: within 48–72 hours of receipt at lab

Phosphorus ($140)

  • RT-PCR test
  • No prescription needed
  • Saliva sample
  • Mail to lab for testing
  • Estimated turnaround time: within 72 hours of receipt at lab

Pixel by LabCorp (no upfront cost; can be covered by insurance or government funds)

  • RT-PCR test
  • No prescription needed; must complete questionnaire
  • Nasal swab
  • Mail to lab for testing
  • Estimated turnaround time: within 24–48 hours of receipt at lab

Note that the above tests are not antibody tests, which tell you if you’ve had COVID-19 previously; at-home tests referred to here are designed to determine if you are currently infected with COVID-19 and have the potential to infect others.

Just like point-of-care diagnostic tests (ones administered at doctors offices, nursing home facilities, or other authorized testing sites), you’ll find that the range of available at-home tests vary slightly in a few ways, including how you collect a sample (e.g., saliva or nasal swab), virus detection method (molecular or antigen tests), and where the samples get tested (in a lab or right there in your home).

The method used to detect the presence of the virus: molecular vs. antigen testing

“Of the 39 FDA-authorized tests, there are 37 PCR (molecular) tests and two antigen tests,” Fehling says. As defined by the FDA, a molecular test detects the genetic material present in a virus particle, and most molecular tests are polymerase chain reaction (PCR) tests. Antigen tests, on the other hand, detect specific proteins from a virus particle. 

What’s the difference—is one better than the other?

The timeline for results does differ between the two. PCR test results come back anywhere from several hours to several days, although some point-of-care results can be less than an hour. Antigen tests are typically much more rapid, taking less than an hour to receive results. 

Fehling explains the main difference between antigen and PCR tests is the amount of viral load they require to detect the presence of COVID-19 reliably. PCR tests can detect COVID-19 in lower viral amounts using an amplification technique, and can identify the presence of the virus earlier in the course of infection than an antigen test can. “For example, consumers can use PCR/molecular tests throughout an infection period, while antigen-based tests have a finite window of detection and are typically the most accurate five to seven days from symptom onset,” she says. 

Additionally, “antigen tests need higher amounts of the virus to be present in an individual’s system for the best chance of detection,” Fehling says. She adds that while antigen tests tend to be best for individuals showing symptoms—especially when they need results ASAP—recent “research has found that the accuracy of antigen tests dropped to 41.2 percent when used for individuals not displaying symptoms of COVID-19.” On the whole, molecular tests are less likely to give you a false positive or false negative when compared to antigen tests. 

“The FDA and CDC still consider PCR tests as the ‘gold standard’ in COVID-19 testing since they have much lower rates of false positives and negatives; both organizations find PCR tests are highly accurate and individuals typically do not require additional confirmation or testing if their results come back positive,” Fehling says. “While an antigen test can enable rapid at-home testing, individuals may actually end up spending more time and money on additional testing (usually PCR) to confirm their results.”  

For example, the at-home antigen test from Ellume—the first fully at-home test kit confirmed for EUA by the FDA on December 15, 2020—provides super-fast results without requiring a prescription or shipping the nasal swab sample for lab work. However, the FDA does “recommend that any asymptomatic individuals who receive a positive result should be treated as ‘presumptively positive until confirmed by another test as soon as possible,’” Fehling notes, and adds, “likewise, symptomatic individuals who receive a negative result from an antigen test should also confirm their results with additional testing.”

The type of sample required: saliva vs. nasal swab 

“A total of eight tests feature saliva as a sample type while the rest use nasal swabs,” Fehling says. For a saliva sample, users will spit into a test vial; for a nasal sample, users must insert a nasal swab into the nostril and swirl, then seal the swab into a collection tube. 

Is one better than the other? 

Studies have found both saliva and nasopharyngeal nasal swabs to have comparable efficacy rates for detecting the virus. However, saliva collection tends to leave less room for human error.

“Nasal swabs are challenging to self-administer, [and can lead] to improper sample collection that adversely affects test accuracy. Studies have shown nasal swabs have up to a 30 to 40 percent false negative rate.” Fehling says. “By comparison, saliva-based tests are more consumer-friendly and less prone to user error because they have an easier, more comfortable collection process that produces a consistent sample every time. All you have to do is provide a small saliva sample in a tube.”

Where and how the collected samples get tested: at-home vs. in a lab

“Thirty-six tests require self-collected samples to be sent into a laboratory for testing, and three tests can be processed at home,” Fehling says. 

“Individuals can use at-home tests for a variety of scenarios,” Fehling says, and lists the following examples. 

  •  If you’re eligible for a vaccine and want an at-home testing to confirm a negative result before getting your shot. (Fehling says that vaccine manufacturers have advised against vaccine administration in those individuals with active COVID infection.)
  • If you have a disability preventing you from traveling to a testing site.
  • If you’re  traveling and a negative test is required for entry; general precautionary testing during and after travel.
  • If you believe you’ve been exposed to COVID-19.
  • If you live somewhere without convenient access to testing.
  • If you want to test for the virus before and after a group gathering, per individual state regulations (like, a wedding or funeral).
  • If you’re a college student returning to school campus or after exposure during quarantine.