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Popular Science Review Finds Seven At-Home COVID-19 Antigen Tests ‘Easy to Use’ and ‘An Important Tool to Slow Spread of the Coronavirus’

Jun 2, 2021 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations

Though clinical laboratory RT-PCR tests remain the ‘gold standard’ when diagnosing COVID-19, at-home antigen tests offer convenience and quick test results. But are they accurate?

Less than six months after the US Food and Drug Administration (FDA) issued the first ever emergency use authorization (EUA) for an over-the-counter SARS-CoV-2 diagnostic test to Ellume for its COVID-19 at-home antigen test, the number of do-it-yourself at-home tests available to consumers has grown large enough for Popular Science to publish a review of available consumer COVID-19 testing kits.

Clinical laboratory and pathologists generally acknowledge that RT-Polymerase Chain Reaction (RT-PCR) tests remain the preferred method for detecting COVID-19 disease. However, according to Popular Science, rapid at-home antigen tests that accurately identify people carrying larger loads of the virus are becoming important tools in the fight against spread of the coronavirus.

In “We Vetted Popular At-Home COVID-19 Tests. Here’s What We Learned: Everything you need to know about the growing number of at-home testing options for COVID,” Popular Science evaluated the ease-of-use and effectiveness of the following tests:

Many of the newest at-home tests not only have users collect their own swab or saliva samples, but some also provide results in less than an hour, which can be sent to the user’s smartphone. Conversely, home-based collection kits that are returned to clinical laboratories for testing can take 48 hours or longer for shipping and processing.

ellume-home-covid-test
The FDA’s emergency use authorization announcement (EUA) for Ellume’s $38.99 COVID-19 At Home Test (above) states the test “is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual two years of age or older.” Ellume’s self-collection test was the first such test to receive an FDA EUA for use without a physician’s order. (Photo copyright: Ellume).

Are At-Home COVID-19 Tests a Good Idea?

“The more we can do simple, regular, at-home testing, the less we need it,” Mara Aspinall, Professor, College of Health Solutions at Arizona State University, told Popular Science. “It’ll become a habit, as easy as brushing your teeth,” she added.

But in “Pathologists Urge Caution on At-Home COVID Test Kits,” MedPage Today, reporting on the College of American Pathologists (CAP) March 11 virtual media briefing, pointed out downsides to at-home COVID-19 tests.

Among the issues cited were the potential for inadequate samples and improper handling to cause inaccurate results, as well as uncertainty whether at-home antigen tests will pick up on COVID-19 variants.

At-home tests also are less likely to be covered by insurance, MedPage Today reported.

kalisha-hill-MD-head-shot
During the CAP virtual media briefing, pathologist Kalisha Hill, MD (above), Chief Medical Officer and Chair, Department of Pathology and Medical Director, Laboratory Services, at AMITA Health St. Mary’s Kankakee (Ill.), said, “The gold standard is still a laboratory-performed real-time PCR test and that is the most sensitive and most accurate that we do that is very specific for COVID-19.” Hill called at-home tests a “good screening tool,” but she noted, “You’re testing that moment, that day, and as soon as you leave your home or come in contact with someone else, you could potentially be COVID positive. It’s also important to recognize that when you’re collecting a sample yourself, you may not be able to obtain enough sample for an accurate result … It’s very important how it is collected and also the sensitivity and specificity of the test,” she added. (Photo copyright: AMITA Health/LinkedIn.)

How Do the Tests’ Accuracy Compare?

The Quest Direct and LabCorp Pixel tests—both of which are sent to company labs for PCR testing—scored highest on the two main statistical measures of performance sensitivity (positive percent agreement) and specificity (negative percent agreement). According to Popular Science, each of these tests’ sensitivities and specificities are close to 100%.

According to the websites of the other tests reviewed by Popular Science:

  • DxTerity test, which uses a saliva sample—97.2% sensitivity and a 92.5% specificity.
  • BinaxNOW test—84.6% sensitivity and 98.5% specificity.
  • Cue COVID-19 test—98.7% sensitivity and 97.6% specificity.
  • Lucira Check Its test—98% accuracy.
  • Ellume test—95% sensitivity and 97% specificity.

Rapid Antigen Tests Accurate and Easy to Use, says Popular Science

Popular Science found the tests generally easy to use and concluded they are a beneficial—if imperfect—tool in the fight against COVID-19.

“If you’re unvaccinated and symptomatic, they’re a great way to confirm a COVID-19 infection without risking a trip out of the house,” Popular Science stated in its article. “If you’re unvaccinated and have no symptoms, and just want to know whether you can safely attend a family dinner or soccer game, an at-home test remains an imperfect way of self-screening. Remember: If the test comes back negative, there’s still the chance the result is false, and you could accidentally expose others by being within six feet of them without a mask on.”

As the popularity of at-home COVID-19 tests increases, clinical laboratories that perform RT-PCR tests may want to keep a watchful eye on the demand for at-home rapid antigen testing, especially now that some tests are available without prescription.

—Andrea Downing Peck

Related Information:

We Vetted Popular At-Home COVID-19 Tests. Here’s What We Learned

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Pathologists Urge Caution On At-Home COVID Test Kits

The Rapidly Changing COVID-19 Testing Landscape: Vaccines, Variants, and Health Disparities

Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use

DxTerity SARS-CoV-2 RT-PCR Test EUA Summary

Ellume’s COVID-19 Home Test Shows 96% Accuracy in Multi-Site US Clinical Study

Airlines Are Partnering with Health Companies and Clinical Laboratories to Implement At-Home COVID-19 Testing Prior to Flights

Dec 9, 2020 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations

Because air travel volumes are low, experts believe it is timely to develop COVID-19 testing systems and gain insight on which protocols are most effective

As the COVID-19 pandemic surges on, several international airlines now require customers to complete at-home COVID-19 testing before they can travel. This is triggering unusual business practices. For example, one airline allows its passengers to use frequent flier miles to purchase mail-in COVID-19 test kits.

Frequent Flyer Miles for COVID-19 Testing

Across the United States, Hawaii has one of the lowest rates of infection, partly thanks to the state’s strict quarantine regulations. In a state, however, that depends on tourism for its economic health, the pandemic has caused serious financial difficulties. In an effort to prevent spread of the coronavirus while also encouraging tourism, Hawaiian Airlines now offers “Pre-travel COVID-19 Test Options” on its website.

To be allowed to skip the state’s mandatory 14-day self-quarantine before arriving on the islands, flyers can take a pre-travel coronavirus test with the following conditions:

  • The test must be from a state-approved testing provider.
  • The test must be administered no more than 72 hours prior to the scheduled departure time of the final leg to Hawaii.
  • For trans-pacific travel, test results must be received prior to flight departure.

Additionally, the airline accepts frequent flyer miles to pay for mail-in COVID-19 tests. In exchange for 14,000 HawaiianMiles, a passenger receives a test kit in the mail. The kit features a video call during which a healthcare professional guides the consumer on taking a saliva sample. The user then ships the sample to a qualified clinical laboratory. Results are returned electronically within 24 hours of the lab receiving the sample.

Hawaii’s COVID-19 portal states, “The state of Hawaii will ONLY accept Nucleic Acid Amplification Test (NAAT) from a certified Clinical Laboratory Improvement Amendment (CLIA) lab test results from Trusted Testing and Travel Partners” that are participating in the state’s pre-travel testing program. Honolulu and Maui are the only two arrival airports allowed. A negative result must have come from a test performed within 72 hours prior to the final leg of the passenger’s trip to Hawaii, according to the portal.

“A negative pre-travel test is an alternative to two weeks in self-isolation for arrivals to the archipelago,” the UK’s Independent reported.

JetBlue and Vault Health Partner to Offer COVID Testing to Airline Passengers

In another instance of an airline getting involved in at-home testing, JetBlue (NASDAQ:JBLU) is partnering with Vault Health to offer at-home testing. The process is similar to the Hawaiian Airlines program. However, rather than purchasing the test with frequent flyer miles, JetBlue offers polymerase chain reaction (PCR) tests at a discount.

Business Travel News reported that passengers must provide a confirmation code while ordering the $119 test from Vault Health’s webpage. “Vault provides a kit for an at-home saliva test, and users administrate it while on a video chat supervised by Vault to ensure the test is done properly. The user sends it overnight to a clinical laboratory and the results are provided within 72 hours,” Business Travel News stated.

Joanna Geraghty of JetBlue
“We continue to hear from health officials that [COVID-19] testing is incredibly important in the fight against the coronavirus, and we want to make sure our customers have options for testing, especially prior to travel,” said Joanna Geraghty, President and Chief Operating Officer, JetBlue, in a press release. “As more and more regions reopen, many are requiring test results to enter. Now with easier testing options, those safety requirements may not be a deterrent for travel, but rather provide greater public health and peace of mind with little inconvenience.” (Photo copyright: Spectrum News NY1.)

In “Coronavirus Testing Before Flying Could Become the Norm as Airlines Try to Boost Confidence and Woo Travelers,” the Washington Post reported, “There is no common standard, so it has been left to airlines and airports to design their own SARS-CoV-2 testing programs and for travelers to sort out requirements for their particular destination.”

In addition to airlines such as Hawaii Airlines and JetBlue instituting programs for coronavirus testing, some airports are as well. Tampa International Airport, for example, test-piloted a voluntary testing program for all arriving and departing passengers from October 1st to October 31st. The airport partnered with BayCare, a 15-hospital Tampa area healthcare network, to provide both rapid antigen and PCR tests.

“Testing services will be offered on a walk-in basis … seven days a week from 8 a.m. until 2 p.m. The pilot will be open to all ticketed passengers who are flying or have flown within three days and can show proof of travel. The PCR COVID-19 test costs $125 and the antigen test costs $57,” a press release stated.

Tampa Airport CEO Joe Lopano told the Washington Post, “This could be—especially if adopted by other airports—another way to instill confidence.”

COVID-19 Testing by Retailers Expanding as Well

Travelers aren’t the only people who need testing. Some employers also are requiring negative tests before employees can return to work.

In “Costco Begins Selling an At-Home Self-Collection COVID-19 Test Kit; One of 12 Kits That Have Received FDA Emergency Use Authorization,” Dark Daily reported on retail giant Costco’s (NASDAQ:COST) response to increased demand for COVID-19 testing by offering direct-to-consumer, at-home test kits to its members. The kits sell at two price points: $129 for a “basic” kit, and $139 for a kit that includes “Video observation for travel.” The more expensive test is accepted by Hawaii for its Trusted Testing Partner Program.

As with all at-home kits, the consumer collects their own specimen and sends it off to a qualified clinical laboratory for processing. AZOVA, a telehealth company, supplies the kits to Costco for resale and provides a smartphone app where customers can check and display the test results.

P23 Labs’ TaqPath SARS-CoV-2 assay is the test being used, which, according to P23, “has a 98% sensitivity and 99% specificity,” Business Insider reported.

When COVID-19 Testing Fails

Of course, coronavirus testing isn’t 100% guaranteed. The Independent reported in November that a passenger on a Dubai to New Zealand flight who had tested negative prior to flying, was, in fact, positive for coronavirus and had infected seven other passengers during the flight. New Zealand’s Institute of Environmental Science and Research conducted and published a study following the incident, titled, “A Case Study of Extended In-Flight Transmission of SARS-Cov-2 En Route to Aotearoa New Zealand.”

The researchers found that “All seven SARS-CoV-2 genomes were genetically identical, with the exception of a single mutation in one case, and all genomes had five signature mutations seen in only six other genomes from the >155,000 genomes sequenced globally. Four of these six related genome sequences were from Switzerland, the country of origin of the suspected index case.”

They added, “By combining information on disease progression, travel dynamics, and genomic analysis, we conclude that at least four in-flight transmission events of SARS-CoV-2 likely took place.”

At-home test kits for COVID-19 are here to stay. That large businesses in multiple industries are now partnering with COVID-19 test developers and clinical laboratory companies to accomplish testing of customers and employees means independent labs that process coronavirus testing can look forward to increasing COVID-19 testing business.

“We need to be using the time now, when [travel] volumes are relatively low, to test the systems and gain insight on which protocols are most effective,” Mara Aspinall, biomedical diagnostics professor at Arizona State University, President and CEO of the Health Catalysts Group, an investment and advisory firm, and former President/CEO of Ventana Medical Systems (now Roche Tissue Diagnostics), a billion-dollar division of Swiss pharmaceutical and diagnostics manufacturer Roche, told the Washington Post.

—Dava Stewart

Related Information:

‘Swap Frequent-Flyer Miles for COVID Test’ Says Airline

Negative COVID-19 Test Result Required Prior to Departure to Avoid 14-Day Quarantine in Hawaii. Tests ONLY Accepted from TRUSTED TESTING AND TRAVEL PARTNERS

JetBlue to Give Passengers At-Home Covid-19 Testing Access

JetBlue to Offer At-Home Pre-Travel COVID-19 Tests

JetBlue and Vault Health Partner to Make At-Home COVID-19 Tests More Widely Available to Customers

Coronavirus Testing Before Flying Could Become the Norm as Airlines Try to Boost Confidence and Woo Travelers

TPA Launches First in the Nation COVID-19 Testing for All Departing and Arriving Passengers

Domestic U.S. Travel Advisories

American Airlines Expands At-Home Coronavirus Testing

COVID: Passenger Infected Four Others on Flight After Testing Negative, Report Says

A Case Study of Extended In-Flight Transmission of SARS-Cov-2 En Route to Aotearoa New Zealand

Costco Begins Selling an At-Home Self-Collection COVID-19 Test Kit; One of 12 Kits That Have Received FDA Emergency Use Authorization

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