FAQ: FDA Approval of the 1-Minute INSTI® HIV Self Test
Summary
The FDA has approved the INSTI® HIV Self Test, the first one-minute HIV self-test available in the U.S. This represents a major advancement in HIV prevention by providing fast, private testing that helps overcome barriers to traditional healthcare and supports national goals to reduce HIV infections.
What is the INSTI® HIV Self Test?
The INSTI® HIV Self Test is the first FDA-approved one-minute HIV self-test that delivers highly accurate results in 60 seconds or less, providing a private and reliable way for people to learn their HIV status at home.
Why is this FDA approval significant for HIV prevention?
This approval is significant because it makes HIV testing faster, easier, and more accessible, helping address critical gaps in screening and supporting the U.S. public health goal of reducing HIV infections by 90% by 2030 through the Ending the HIV Epidemic initiative.
How does the INSTI® HIV Self Test work?
The test requires just a single drop of blood from a fingertip and provides highly accurate results in just one minute, offering immediate answers and reducing the anxiety of waiting for test results.
What are the key benefits of this HIV self-test?
Key benefits include ultra-fast results in 60 seconds or less (the fastest available), high accuracy, convenience as it’s shelf-stable and portable, and privacy since it can be used at home without appointments.
Who developed and manufactures the INSTI® HIV Self Test?
The test was developed and is manufactured by bioLytical Laboratories Inc. (bioLytical), with the FDA approval reflecting the scientific integrity of their work and commitment to expanding access to rapid, reliable diagnostics.
When will the INSTI® HIV Self Test be available to consumers?
The test will be available soon at major retailers and online, according to the announcement made on October 14, 2025.
Where can people get the INSTI® HIV Self Test?
The test will be available at major retailers and online, and consumers can visit bioLytical’s website for updates and purchasing details.
Why is rapid HIV testing important in the United States?
Rapid HIV testing is crucial because an estimated 1.2 million Americans are living with HIV, approximately 13% don’t know they have it, and most new infections come from individuals unaware of their status, with over 30,000 new infections occurring each year.
How does this self-test help overcome barriers to HIV testing?
The test helps overcome barriers by providing a portable, discreet option that eliminates the need for clinic appointments, addressing challenges related to stigma, cost, or location that prevent people from accessing traditional healthcare.
What should people do if they want more information about the INSTI® HIV Self Test?
People should visit bioLytical’s website for updates and purchasing details about the INSTI® HIV Self Test.
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