FDA Approves First Home Use Rapid Test for COVID-19 and Influenza A/B

FDA Authorization of Home Use Rapid Antigen Test

The U.S. Food and Drug Administration (FDA) has authorized the marketing of the first rapid antigen test designed for home use to detect both COVID-19 and influenza A/B, developed by Healgen. This groundbreaking test, which does not require a prescription, delivers results in approximately 15 minutes using a nasal swab sample.

While the test is a valuable tool for early detection, users should be aware of the risk of false negatives. It is advised to seek medical attention if symptoms persist, and individuals who receive positive results should take precautions to prevent virus transmission.

To ensure the test's safety and effectiveness, the FDA has established rigorous criteria for labeling and performance testing. This authorization creates a new regulatory classification, streamlining the process for future similar devices to gain marketing approval.

Key Features of the Test

• Detection: It identifies proteins from SARS-CoV-2 (COVID-19) as well as influenza A and B viruses.
• Target Users: Suitable for individuals aged 14 and older who can self-administer, and for those 2 years and older when samples are collected by an adult.
• Rapid Results: Facilitates timely health decisions by providing results quickly at home.

FDA Accuracy Rates

The FDA's review demonstrated high accuracy rates:

• COVID-19: 99% accuracy for negative samples, 92% for positive samples.
• Flu A: 99.9% accuracy for negative samples, 92.5% for positive samples.
• Flu B: 99.9% accuracy for negative samples, 90.5% for positive samples.

Validation data was sourced through the Independent Test Assessment Program (ITAP), a collaboration between the National Institutes of Health (NIH) and the FDA.

This landmark approval represents the first over-the-counter test authorized for detecting both influenza and COVID-19 without an emergency use declaration. It significantly enhances public health responses, particularly during flu season, by allowing individuals to assess their health from home.

Link to Source

Link to Source - https://www.fda.gov/news-events/press-announcements/la-fda-autoriza-la-comercializacion-de-la-primera-prueba-combinada-de-deteccion-de-la-gripe-y-el