FDA Recommended HIV Test Kits

Food and Drug Administration (FDA) also abbreviated as USFDA is a United State Federal regulatory body from the US Department of Health and Human services and one the US Federal Executive Departments. Amongst other responsibilities, FDA is responsible for protection and promotion of public health through regulation and supervision of medications, vaccines, biopharmaceuticals, blood transfusions and medical devices. Having this in mind, it’s easier to understand about the FDA and HIV and the recommended HIV Test Kits.

Home HIV TEST Chuck Zovko June 21, 2012 Zovko Photographic llc

FDA regulates the tests that detect the Human Immunodeficiency Virus (HIV) infection. This it does in an attempt to promote public health: HIV causes AIDs (Acquired Immune Deficiency Syndrome) which weakens the body system that fights diseases leading to a group of health problems that make a disease. As such, the FDA approves a number of test options through which people can know their HIV status:

  • In their home, individuals can collect a sample, run the test and obtain their own test results
  • In their home, individuals can collect a sample and forward it to a medical laboratory for trained health professionals to run the test. They could then obtain the test results from the medical laboratory.
  • Trained medical professionals can collect samples from an individual(s), test it in a professional medical setting. Individuals could then obtain the test results from a trained health professional.

FDA Recommended HIV Test Kits

  • OralQuick In-Home HIV Test

This a home-use rapid HIV test that was approved by the FDA on July 3, 2012. It is a self-test that provides result in just a few minutes, approximately 20-40 minute. The test does not require laboratory analysis because it is simple to perform and besides, it only requires a fluid from your mouth as a sample. This kit is thus approved for sale both in stores and online for persons not below 17 years of age.

Despite of the approval, the FDA created awareness of a few concerns on the results of the OralQuick In-Home HIV Test. One of the concerns is false negativity. According to FDA, the test result could test negative if the test is conducted within the three months of infection. Secondly, Positive test results using the OralQuick test must be confirmed through laboratory-based testing. FDA also required those who engage in behaviors that increase risks of contacting the virus – such as engaging in unprotected sex with new partners, injecting drugs, sharing shape objects amongst others – should regularly be re-tested. FDA warned people from misinterpreting a negative result to indicate that engaging in risky behavior is safe because that is not always the case.

  • Home Access HIV-1 Test System

The Home Access HIV-1 Test System is a home-use test just like the OralQuick test. The test involves piercing your finger to collect a blood sample. That sample is sent to a licensed medical laboratory for analysis. The results are collected on the following business day. Because of the anonymity of the Home Access HIV-1 Test System, a follow-up test is part of the results and especially if those results were positive. Home Access HIV-1 Test System finds infection faster after infection than OralQuick but definitely not as first as laboratory based tests that uses blood directly from a vein.

  • HIV RNA Early Detection Test

This test is FDA approved offered by an online STD Testing service (STDcheck.com). The test is RNA based and the STDcheck.com testing centers (more than4000 of them) are conveniently located nationwide. All you do is forward a blood sample and collect your results within 48 hrs. The test aims at detecting presence of HIV RNA in the patient’s plasma. It is considered more accurate and super-sensitive by the providers as it is capable of detecting acute HIV infection without the presence of antibodies- Antibodies are the proteins produced by the body to fight against antigens and in this case, the HIV virus. Studies have shown that the HIV RNA detection test can be taken as early as 9-11 days after a possible exposure to HIV. If the test results turn out to be positive, then a follow up testing is recommended together with the necessary guidance and counseling.

  • HIV 4th Generation Antibody Test

This is an FDA approved test that evaluates the blood for HIV Type 1 and 2 by detecting both the antibodies and antigens to the HIV. This test is very similar to the HIV RNA Early Detection Test. HIV 4th Generation Antibody Test looks for the antibodies in the blood and also searches for the antigens on the surface of the Human Immunodeficiency Virus. If any of either the antibody or the antigen to HIV is found, then a supplemental differentiation assay is performed to confirm the presence of HIV. According to the experts, this text can be performed 14-21 days after a possible exposure to HIV. The argument is that most people tend to develop antibodies within 2-3 weeks of HIV exposure except in the rare cases where the antibodies will take up to 3 months to develop. In any case, it is always recommendable that a re-test be undertaken after 3 months in order to obtain conclusive results.

Other than these individual-centered FDA recommended HIV test kits, this federal regulatory body has significantly raised its oversight of the blood industry in the effort to protect patients from exposure to HIV through blood transfusion. As such, FDA requires blood centers to maintain lists of the unsuitable donors (those found to be positive or to whom risk factors have been acknowledged) in order to prevent further donations from them. FDA also requires that after donation, blood be rigorous screened to confirm its safety. Additionally, the agency performs an inspection on all blood facilities at least every two years. FDA recommendation on HIV test was influenced by research results that show that a good number of people in the US (about 1.2 million people) live with HIV and about 156,300 of that population do not know they are infected. Almost 45,000 people are diagnosed annually and 30% of the new infections are transmitted by people who have no idea whether they are infected. As such, FDA takes HIV testing to be the first step in reducing spread of the virus as well as maintaining a healthy life.



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