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COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document

COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document

Source : Medtech Insight

The US Food and Drug Administration has issued two new templates for developers to use in drafting emergency use authorization (EUA) requests for serology tests for COVID-19, reflecting the growing role the tests play in tracking and managing the pandemic.

The first new template is the serology template for test developers, which replaces previous separate documents for commercial manufacturers and laboratories. The template has also been updated to incorporate new recommendations on presenting clinical agreement data stratified by time from symptom onset, as well as recommendations for tests with semi-quantitative claims.

The other new template is for serology tests intended for home use, in which an individual uses a fingerstick device to collect a blood spot specimen that can then be sent to a lab and analyzed for COVID-19 antibodies. The document includes separate suggestions depending on whether the test is new, or has already been authorized for use in clinical settings. In all cases, sponsors are directed to explain how they are qualifying patients for at-home testing – such as through a questionnaire, or in-person or telehealth appointment. The template also directs sponsors to detail how the blood spot specimen will be collected, stabilized and shipped to the testing lab, and includes a section to list lab partners.

A total of 10 templates are now available, including templates on antigen testing and molecular diagnostics intended for various audiences. The FDA notes that while the documents reflect the agency’s recommended approach to the EUA, sponsors are still welcome to use different tactics, if appropriate.

Serology tests detect the presence of antibodies to the coronavirus in a patient’s blood. This can help identify asymptomatic patients and those who have recovered from the virus. In total, FDA resources show that 58 serology tests currently hold EUA status. However, some tests have been pulled from the market due to accuracy concerns. ()

By Elizabeth Orr