All at-home COVID-19 tests are not equal, so says a new report out from ECRI.
The patient safety and quality not-for-profit evaluated seven antigen tests available in pharmacies and online for ease of use, which can determine both how accurate results are.
"If an at-home test is complicated, if it's cumbersome, it can dramatically increase the error rate, which is of course of concern," said Marcus Schabacker, president and CEO of ECRI. "If you mix up how to do the test, you might get a false positive or more importantly, a false negative test and then you have a degree of comfort that you probably shouldn't have."
The findings are especially relevant as the spread of COVID and its variants causes another surge that's putting pressure on the healthcare system. Having patients test themselves and have results be inaccurate could further affect the course of the pandemic.
The On/Go, CareStart, Flowflex test kits were rates as 'very good,' because of various factors, including clearly printed instructions, providing cases that decrease the chance of interfering with test strip results and helpful apps. QuickVue, BinaxNOW, and InteliSwab were rated as the mid-road 'good,' and present some usability challenges for some users with vision impairment or poor motor control.
BD Veritor ranked at the very bottom, with a 'marginally acceptable' rating, mainly because users have to rely upon the test's accompanying phone app for instructions and results, which ECRI said was time consuming and could prove challenging for people with motor skill impairments.
Schabacker said it's important to also note that none of the seven tests had directions in languages outside of English or Spanish, important factors in considering health equity.
In a statement to Modern Healthcare medical technology company BD said that it invested significant time and resources through focus groups and usability studies to develop the BD Veritor test. The company said the use of smartphone technology with the test is actually a strength.
"BD is the only at-home COVID-19 test to use a smartphone's camera and mobile app to interpret and provide a definitive 'positive' or 'negative' digital display of the result, which eliminates the human subjectivity of a visually read test," wrote Brooke Houston, a BD spokesperson. "We look forward to further reviewing the feedback from the volunteers who participated in the ECRI analysis to determine how we can improve usability even further to increase customer satisfaction for our at-home tests."
Twelve engineers from ECRI's headquarters, comprised mostly of engineers and scientists, conducted the usability tests in Dec. 2021.
The first U.S. over-the-counter at-home test was authorized by the Food and Drug Administration in Dec. 2020. Nearly a year later, President Joe Biden announced that the federal government will purchase and distribute rapid at-home tests to people who request them through a government website. That website will launch after test makers deliver the products through a ramped-up manufacturing capacity. Starting Jan. 15, private insurers will also be required to cover the cost of at-home testing, through a reimbursement process.
