FDA Approves New Rapid HIV Test Delivering Results in 60 Seconds

Richard Klein

Richard Klein, FDA

Earlier this week the Food and Drug Administration (FDA) announced the approval of the INSTI™ HIV-1 Antibody Test, a new, single use rapid test for the detection of HIV antibodies developed by bioLytical Laboratories of Canada. The newly approved test provides results in as little as 60 seconds, in contrast to the six previously approved rapid HIV tests, which typically deliver results in about 10 – 20 minutes.

The new test contributes to the tools available to us as we work toward the National HIV/AIDS Strategy’s goal of increasing the number of people living with HIV who know their serostatus, a critical step in our efforts to curb the spread of HIV/AIDS. Rapid HIV tests allow people to learn their HIV status in a single visit to a testing site, instead of returning days later for results, dramatically increasing the number of people who ultimately learn their serostatus after taking an HIV test.

Rapid testing also helps increase access to HIV testing because testing can be performed outside of the traditional laboratory setting. Individuals who undergo testing can be counseled immediately concerning their HIV status and, if they are positive, given the opportunity to enter medical care.

Read more about FDA’s approval of the INSTI™ HIV-1 Antibody Test.


  1. Dr. Thant Zin says:

    I really appreciated the Global Strategies for the convenience of HIV Patients and improvement of screening, prevention and spread of disease etc.

  2. rohan kapur says:

    sir is this test really effective or to be done in a specific manner
    or just any other diabetic check since it will be faster than any glucometer machine
    so how will this be provided to the public just like any other handheld machine
    or like
    to be done through a route of chain
    diagnostic lab
    please reply
    since there are many who
    are waiting for your answer and if in machine than how will it be availble to the public

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