ECRI Evaluates Seven Home-Based COVID-19 Antigen Tests For Usability

All home tests for COVID-19 are not the same, according to a new ECRI report.

The non-profit organization for patient safety and cost has evaluated seven antigen tests available in pharmacies and online for ease of use, which can determine both the accuracy of the results and the accuracy of the results.

“If a home test is complex, cumbersome, it can dramatically increase the number of errors, which is of course a concern,” said Markus Schabaker, President and CEO of ECRI. “If you mix up how to run the test, you can get a false positive or, more importantly, a false negative test, and then you get a degree of comfort that you probably shouldn’t have.”

The findings are especially relevant as the spread of COVID and its variants is causing another surge that is putting pressure on the healthcare system. Patients testing themselves and getting inaccurate results could further affect the course of a pandemic.

On / Go, CareStart, Flowflex test kits were rated “very good” due to a variety of factors, including clearly printed instructions, sheaths that reduce the likelihood of false test strips, and helpful attachments. QuickVue, BinaxNOW and InteliSwab were rated “good” for an intermediate level and present some usability issues for some users with visual impairments or poor motor control.

BD Veritor ended up at the bottom with a “marginally acceptable” rating, mainly because users have to rely on the phone app that came with the test for instructions and results, which ECRI says is time consuming and can be difficult for people with disabilities. motor skills.

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Shabaker said it is also important to note that none of the seven tests had directions in languages ​​other than English or Spanish, an important factor when considering health equity.

In a statement to Modern Healthcare, medical technology company BD said it spent significant time and resources in focus groups and usability studies to develop the BD Veritor test. The company said that the use of smartphone technology in the test is in fact a strong point.

“BD is the only home test for COVID-19 that uses a smartphone camera and mobile app to interpret and provide a final ‘positive’ or ‘negative’ digital display of the result, eliminating the human subjectivity of a visually readable test. “- wrote Brooke Houston, spokesman for BD.” We look forward to further examining the feedback from volunteers who participated in the ECRI analysis to determine how we can further improve usability to improve customer satisfaction with our home tests. “

Twelve engineers from ECRI headquarters, mainly engineers and scientists, conducted usability tests in December 2021.

The first OTC home test in the United States was approved by the FDA in December 2020. Almost a year later, President Joe Biden announced that the federal government would purchase and distribute rapid home tests to people who request them through the government website. This website will be launched after the test makers deliver products through the capacity ramp. Beginning January 15, private insurance companies will also have to cover the costs of home testing as part of the reimbursement process.

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