OraQuick in Home HIV Test: Correct Usage, False Negatives, & Accuracy

This week, the U.S. Food and Drug Administration (FDA) approved OraQuick in-Home HIV Test, the first ever over-the-counter test that allows people to determine whether they are infected with the Human Immunodeficiency Virus in the privacy of their own home. This will make it easy for you and me to know whether we are infected with the deadly HIV, but how reliable is this test?

OraQuick is extremely accurate when conducted by professionals but it does become less reliable when done by do-it-yourselfers who are the main target of the OraQuick in-Home HIV test. According to the New York Times, researchers have found that the home test is “accurate 99.98 percent of the time for people who do not have the virus”. This means that about one in 5,000 people would have a false positive test. In other words, OraQuick in-Home test will say that said person is positive for HIV even when s/he in fact does not have the disease.

The accuracy of the Oraquick in-Home test drops to only 92% among people who actually have HIV. Ninety two percent still sounds pretty accurate, no? Actually, not really. This means that about “one person in 12 could get a false negative”. Yup, you read that right. About one in 12 people who have HIV will be told that s/he does not have the virus even when s/he, in fact, is HIV positive.

OraQuick will be available starting October this year in some 30,000 pharmacies, grocery stores and online retailers.

How much is the OraQuick in-home test kit? The manufacturers have yet to set a price but it will reportedly cost higher than the price charged medical professionals (which is currently pegged at $17.50) as the company has to do a more complicated packaging and maintain a 24-hour hotline.

Some DO’s and DON’Ts you should remember when you take the OraQuick at-home test. [Source: OraSure]

  • Make sure you are taking the test in a place with good lighting.
  • If you have participated in a HIV vaccine clinical trial, you may get a positive result using this test, but it may not mean that you are infected with HIV. You should seek followup with the research group.
  • If the tamper evident seal has been broken or if any of the package contents are missing, broken, or have been opened, do not use this test.
  • If the expiration date of the test is past the date printed on the outside of the box, do not use this test.
  • Do not open any of the packets until you are ready to begin your test.
  • Do not eat, drink or use oral care products (such as mouthwash, toothpaste or whitening strips) 30 minutes before starting the test.
  • Remove dental products such as dentures or any other products that cover your gums prior to the oral collection.
  • Do not use the test if it has been exposed to household cleaning products.
  • Do not use this test if it has been stored outside the acceptable temperature of 36°80°F (2°27°C).

By the way, it is also important to remember that you must be at least 17 years old to use the test. More notes from OraSure:

  • A positive result does not mean that you are definitely infected with HIV, but rather that additional testing should be done in a medical setting.
  • A negative result does not mean that you are definitely not infected with HIV, particularly when exposure may have been within the previous 3 months.
  • If your test is negative and you engage in activities that put you at risk for HIV on a regular basis, you should test regularly.

Finally, some Frequently Asked Questions are clarified below by the drug manufacturer:

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