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          Information regarding the OraQuick In-Home HIV TestApproved Blood Products Information regarding the OraQuick In-Home HIV Test
  
  	
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How the OraQuick In-Home HIV Test Works
	Results
	Comparison
	More Information**How the OraQuick In-Home HIV Test Works**

**What is the OraQuick In-Home HIV Test and how does it work?**

The OraQuick In-Home HIV Test is a rapid self-administered over-the-counter (OTC) test. The OraQuick In-Home HIV Test kit consists of a test stick (device) to collect the specimen, a test tube (vial) to insert the test stick (device) and complete the test, testing directions, two information booklets (“HIV, Testing and Me” and “What your results mean to you”), a disposal bag and phone numbers for consumer support.

This approved test uses oral fluid to check for antibodies to HIV Type 1 and HIV Type 2, the viruses that cause AIDS. The kit is designed to allow you to take the HIV test anonymously and in private with the collection of an oral fluid sample by swabbing your upper and lower gums with the test device. After collecting the sample you insert the device into the kit’s vial which contains a developer solution, wait 20-40 minutes, and read the test result. A positive result with this test does not mean that an individual is definitely infected with HIV but rather that additional testing should be done in a medical setting to confirm the test result. Additionally, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months. Again an individual should obtain a confirmatory test in a medical setting.

**When should I take a test for HIV?**

If you actively engage in behavior that puts you at risk for HIV infection, or your partner engages in such behavior, then you should consider testing on a regular basis. It can take some time for the immune system to produce enough antibodies for the test to detect, and this time period can vary from person to person. This timeframe is commonly referred to as the “window period,” when a person is infected with HIV but antibodies to the virus can not be detected, however, the person may be able to infect others. According to the Centers for Disease Control and Prevention, although it can take up to 6 months to develop antibodies for HIV, most people (97%) will develop detectable antibodies in the first 3 months following the time of their infection.

**How reliable is the OraQuick In-Home HIV Test?**

As noted in the package insert, clinical studies have shown that the OraQuick In-Home HIV Test has an expected performance of approximately 92% for test sensitivity (i.e., the percentage of results that will be positive when HIV is present). This means that one false negative result would be expected out of every 12 test results in HIV infected individuals. The clinical studies also showed that the OraQuick In-Home HIV Test has an expected performance of 99.98% for test specificity (i.e., the percentage of results that will be negative when HIV is not present). This means that one false positive result would be expected out of every 5,000 test results in uninfected individuals.

It is extremely important for those who self-test using the OraQuick In-Home HIV Test to carefully read and follow all labeled directions. Even when used according to the labeled directions, there will be some false negative results and a small number of false positive results. The OraQuick test package contains step-by-step instructions, and there is also an OraQuick Consumer Support Center to assist users in the testing process.

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OraQuick In-Home HIV Test Fact Sheet



**Results**

**If the test says I’m HIV positive, what should I do?**

A positive test result does not necessarily mean that you are infected with HIV. If you test positive for HIV using the OraQuick In-Home Test, you should see your healthcare provider or call the OraQuick Consumer Support Center, which has support center representatives available 24 hours a day/7 days a week to answer your questions and provide referrals to local healthcare providers for follow-up care. You will be advised to obtain confirmatory testing to confirm a positive result or inform you that the initial result was a false positive result. The test kit also contains an information booklet, “What your results mean to You,” which is designed to instruct individuals on what to do once they have obtained their test results.

**Do I need a confirmatory test?**

A positive test result on the OraQuick In-Home HIV Test indicates that you may be infected with HIV. Additional testing in a medical setting will either confirm a positive test result or inform you that the initial result was a false positive result.

**What is a “false positive” result?**

A “false positive” result occurs when an individual not infected with the HIV virus receives a test result that indicates that he or she is infected with HIV.

**If the test says I’m HIV negative, what should I do?**

A negative result on this test does not necessarily mean that you are not infected with HIV. The OraQuick test kit contains an information booklet, “What your results mean to You,” which is designed to instruct individuals on what to do once they have obtained their test results. The test is relatively reliable if there has been sufficient time for HIV antibodies to develop in the infected person. For the OraQuick In-Home HIV Test, that period of time, called the window period, is about three months. If you have recently been engaging in behavior that puts you at high risk for HIV infection, you should take the test again at a later time. Alternatively, you should see your health care provider who can discuss other options for HIV testing.

**What is a “false negative” result?**

A “false negative” result occurs when an HIV-infected individual receives a test result that incorrectly indicates that he or she is not infected with HIV.

**How quickly will I get the results of the OraQuick Test?**

You can read the results of the OraQuick In-Home HIV Test within 20 to 40 minutes

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**Comparison**

**How are unapproved test systems different?**

The manufacturers of unapproved test systems have not submitted data to FDA in order for FDA to review and determine whether their test systems can reliably detect HIV infection. Therefore, FDA cannot give the public any assurance that the results obtained using an unapproved test system are accurate.

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**More Information**

**How can I obtain additional information about the test?**

Information on the OraQuick In-Home HIV Test can be found on FDA’s website.

Additionally, information can be obtained from the manufacturer, OraSure Technologies.

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Resources For You

OraQuick In-Home HIV Test

                                                                                  Content current as of:
      06/03/2020
              
              
Regulated Product(s)
		 BiologicsApproved Blood Products

          
                        Licensed Products (BLAs)
          New Drug Applications (NDAs)
          Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)


                        Substantially Equivalent 510(k) Device Information
 
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