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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:

What does the test do?
The OraQuick® InHome HIV Test is an invitro diagnostic home use test for HIV (HIV1 and HIV2) in oral fluid. This test works by looking for your body’s response (antibodies) to fighting the HIV virus. A positive result is preliminary and followup confirmatory testing is needed.

What kinds of events put me at risk for HIV?
• Sex (vaginal, oral or anal) with multiple sex partners
• Sex with someone who is HIV positive or whose HIV status you don’t know
• Sex between a man and another man
• Using illegal injected drugs or steroids
• Shared needles or syringes
• Exchanged sex for money
• Having been diagnosed or treated for hepatitis, tuberculosis or a sexually transmitted disease like syphilis

How soon after a risk event can I test myself?
This test detects HIV infection if used 3 months after a risk event. If you want to be tested before 3 months, you should go to your doctor or local healthcare provider. If you do not know where to get tested, you can call the OraQuick® Support Center toll free at 18664366527 and a Support Center representative can provide you with the name of a healthcare provider or a clinic in your area.

Why shouldn’t I use this test right after a risk event?
When you have been infected with the HIV virus, your body tries to defend against the HIV virus by producing antibodies to it. These antibodies can be found in your blood or oral fluid. It takes your body up to 3 months to produce these antibodies at levels that can be detected by this test.

Can someone help me with directions on how to take the test correctly?
Yes, the OraQuick® Support Center is available 24 hours a day, 7 days a week, toll free at 18664366527.

A Support Center representative will assist you with any questions you may have on performing the test or connecting you with a healthcare provider in your area. Additionally you can go to www.oraquick.com to view a video on how to take the test. All calls are completely confidential.

Can someone help me read my results?
The OraQuick® Support Center is available 24 hours a day, 7 days a week, toll free at 18664366527.

A Support Center representative will assist you with any questions. Since this is a visually read test, they cannot actually read your results; however, they can help you to understand your test result.

How often should someone test for HIV?
How often you should get tested for HIV depends on your circumstances. If you have never been tested for HIV, you should be tested at least once.

The Centers for Disease Control and Prevention (CDC) recommends being tested at least once a year
if you do things that can result in HIV infection. These include:
• Sex (vaginal, oral or anal) with multiple sex partners
• Sex with someone who is HIV positive or whose HIV status you don’t know
• Sex between a man and another man
• Using illegal injected drugs or steroids
• Shared needles or syringes
• Exchanged sex for money
• Having been diagnosed or treated for hepatitis, tuberculosis or a sexually transmitted disease like syphilis

If you have been exposed to events that could result in HIV infection, you should test 3 months after the event. If you feel you are at risk of being infected with HIV, it is a good idea to test regularly.

What does a negative result mean?
A negative result means that the test has not detected HIV antibodies (your body’s way of fighting the virus). If it has been at least 3 months since you have had a risk event and you followed the directions carefully, you likely do not have HIV. However, as with any test, there is a chance for false results. For this test 8 out of 96 people who actually were infected with HIV reported a negative test result even though they had HIV. This is called a “false negative.” To reduce the chance of false results, be sure to use the test correctly. If it has been less than 3 months since you have had a risk event, wait until the full 3 months have passed to take the test. If you did not follow the directions carefully, you should take the test again to be sure your result is accurate.

What is a false negative?
When a person reads his/her test result as negative, but the true HIV status of the person is positive (infected with HIV).

What can cause a false negative result?
A false negative result can occur for the following reasons:
• If you have had a risk event less than 3 months prior to taking the test
• Incorrectly reading test result as negative
• Not following the test directions carefully
• If you wore dental products such as dentures or any other products that cover your gums while swiping your gums

What does a positive result mean?
A positive result means that you may have HIV. A doctor, clinic or healthcare professional must confirm your OraQuick® InHome HIV Test result.

What should I do if I get a positive result?
You need to follow up with a doctor or healthcare provider to get a confirmatory test. At that time your doctor or healthcare provider will discuss the next steps that need to be taken. You should read the booklet “What your results mean to You!”
If you need help locating a healthcare provider in your area, please call the OraQuick® Support Center toll free at 18664366527.

What is a false positive result?
When a person reads his/her test result as positive and the true HIV status of the person is negative (not infected with HIV).

What can cause a false positive result?

A false positive result can occur for any of the following reasons:
• Incorrectly reading test result as positive
• Not following the test directions carefully
• Not waiting 30 minutes after eating, drinking, or using oral care products before taking the test
• If you have participated in a HIV vaccine clinical trial
• Swiping each gum more than once during oral collection

Is there a way to find out where I can get additional help or care?

You can call the OraQuick® Support Center toll free at 18664366527 and a Support Center representative will be able to provide you with a list of healthcare providers in your area. You may also go to www.oraquick.com.

How can I tell that my test is working correctly?
If your test is working correctly you will see a line next to the “C” on your test stick. If there is no line next to the “C” your test did not work.

What should I do if my test is not working?
If you believe your test may not be working correctly, please call the OraQuick® Support Center toll free at 18664366527 and a Support Center representative will assist you.

Do any drugs or medications affect the test?
To date there is no evidence that the use of antibiotics or medications (not HIV related) affect the test results; however, individuals on treatment for HIV should not use this test.




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