Source : Medtech Insight
Diagnostics companies working on tests for the novel coronavirus that could be distributed over the counter got fresh guidance on 29 July, as the US Food and Drug Administration released a new template that shows what emergency use authorization (EUA) submissions for these tests might look like.
The template addresses the design and development of COVID-19 diagnostic tests that can be performed entirely at home or in other non-lab settings, such as offices or schools, as well as those that won’t require a physician’s prescription. It makes recommendations about validation procedures, clinical trial designs and test performance evaluation strategies, among other topics.
The FDA has already authorized some COVID-19 diagnostics that allow for home sample collection, with the first arriving in April. However, those tests still must be physician-prescribed and shipped to a lab for analysis. ("First US Home Collection COVID19 Test Gets Green Light" "Medtech Insight" )
“The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test,” FDA commissioner Stephen Hahn said in a statement. “We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available.”
The template makes several specific recommendations intended to reduce the risks associated with performing a test at home. For example, sponsors are directed to use either anterior nasal swabs, mid-turbinate swabs or saliva as the sample type, because collection of nasopharyngeal or oropharyngeal swabs requires training and can cause patient harm such as choking or nosebleeds if performed incorrectly.
The template also specifies that test kits should include two sets of instructions, one for self-testing and one for testing somebody else. The instructions should be written in Quick Reference Instruction (QRI) format and limited to one or two pages in length, the agency said.
The template also recommends that test results displayed to the user be simple: positive, negative or invalid. Users should be instructed to consult a physician if they still have concerns after getting a negative result, the FDA says.
This is the seventh EUA template the FDA has released in the fight against COVID-19. In addition to molecular diagnostic and serology templates for commercial and lab use, the agency has also created templates for antigen tests and home specimen collection. The templates are updated as additional information becomes available. ("First US Home Collection COVID19 Test Gets Green Light" "Medtech Insight" )
By Elizabeth Orr