By Ken Alltucker, USA Today
An independent patient safety group Monday unveiled the first public ranking of the most widely used quick and cheap at-home COVID-19 tests based on how easy the products are for consumers to use.
ECRI, a nonprofit also focused on health care quality and cost-effectiveness, evaluated seven no-prescription rapid antigen tests sold via Amazon and chain retailers. The over-the-counter tests were assessed on measures a consumer might find useful such as ease of handling, reading and following instructions and interpreting results.
The purpose is to give consumers a guide when choosing among the confusing array of tests used by millions of Americans who want convenient and reliable options.
"We have no horse in this race – we want to make sure consumers have the best possible access," said ECRI CEO Marcus Schabacker. "Some of them are very easy to use, some are very difficult, and some are in between."
ECRI assigned 12 staff engineers who ranked tests using a decades-old, industry-standard scale to rate designs of a broad range of products and services.
Intrivo's On/Go antigen test garnered the top score of 82.9 on a 100-point scale; BD Veritor ranked the lowest at 51.8. The judges didn't find any test to be excellent nor unacceptable.
CareStart and FlowFlex rapid antigen tests joined On/Go as top-tier kits for ease of use and handling. The nation's most widely used rapid antigen test, Abbott Laboratories' BinaxNow, ranked as a middle-tier test; Quidel's QuickVue and InteliSwab received similar scores.
A person who is disabled or has tremors might have trouble performing functions such as removing a cap or adding drops to the testing strip, and results might be difficult to read for the visually impaired, the report said.
Since the beginning of the COVID-19 pandemic, the Food and Drug Administration has authorized dozens of coronavirus tests for use in labs, doctors offices and even in homes. Some home tests allow consumers to collect a saliva or nasal sample in a container and ship the sample to a lab for testing. The telehealth company eMed overnights tests to consumers' homes, remotely monitors the person as they take the test, and certifies results that might be required by an airline or an employer.
The FDA has granted emergency use authorization to a dozen companies to sell rapid antigen home tests at retail stores. Consumers can buy these non-prescription tests online or at retailers such as CVS, Walgreens and Amazon.
But kits have been hard to find for many consumers as the highly contagious omicron variant drives demand to unprecedented levels. ECRI chose seven tests available for purchase via Amazon or other retailers – the same tests consumers shopping for a retail test would most likely be able to purchase.
ECRI's review didn't gauge other factors such as accuracy, affordability and whether they included apps that automatically reported results to federal and state public health agencies. Prices listed on Amazon range from $17 for FlowFlex to $34 for BD Veritor.
President Joe Biden seeks to ease the shortage and supply 500 million free home testing kits to Americans. The administration plans to set up a website where consumers can request the kits, which would be mailed to the homes of those who want them, possibly starting in the coming weeks. The United Kingdom and Germany, among other countries, have already made massive purchases and provided free tests to their citizens.
Testing experts not involved with the survey said clear and easy-to-understand instructions are crucial to avoid missteps. A person who misses the mark with a nasal swab might not get enough sample to accurately test. Or a person might skip a step such as adding chemical drops to the test card.
"I have a tendency, as a consumer, to want to just open up the package and start swabbing," said Dr. Emily Volk, president of the College of American Pathologists. "To minimize the chance that you get a false negative or false positive result, you've got to follow the directions to the letter."
Even though the category of home tests evaluated by ECRI don't require medical oversight, Volk said it's a good idea for consumers who test positive to notify a doctor. A doctor could advise and connect a person at risk for complications to more advanced COVID-19 treatments such as antivirals or monoclonal antibodies.
Volk said doctors and other medical professionals also will report positive tests to state and local health departments because consumers are unlikely to do that on their own.
"I don't imagine most people are going to want to take the trouble to call their public health department and tell them that they're positive for COVID from a home test," Volk said.
Reviewers dinged BD Veritor because it did not include written instructions, instead directing users to an app with videos for each test step. The reviewers said repeating these steps for multiple tests "would be frustrating and makes the test take longer than necessary."
Two-thirds of the reviewers said the test was the most difficult to use.
Becton Dickinson, the company that makes BD Veritor, gathered input from focus groups and studies to fix limitations common with these types of tests, spokesman Troy Kirkpatrick said in an email.
Kirkpatrick said the test uses a smartphone's camera and app to interpret and display test results, provides step-by-step video instructions and automatically reports results to federal and state public health agencies. Many home tests don't have such a feature, so consumers must report results on their own.
On/Go received high marks for its simple design, good printed instructions and the optional app. The app also allows users to skip ahead if they know how to perform a step.
Intrivo CEO Ron Gutman said designers tried to make the On/Go test simple with lighthearted touches such as an animated instruction video because consumers are stressed when checking for infection.
"People who are not familiar with medical devices are scared and concerned" when testing, Gutman said. "You need to simplify it to the nth degree."