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Oral HIV Self-Testing Information for Health Care Providers

Information for Health Care Providers

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Testing — General Recommendations
The Centers for Disease Control and Prevention (CDC) recommends that every person aged 13 to 64 test at least once for HIV regardless of risk factors. For those with increased risk for contracting HIV, testing should be done as often as every six months depending on the number and type of risk factors. Identifying a person's risk factors is important in determining an appropriate schedule for HIV testing. Persons at increased risk of HIV infection include:

  • Men who have sex with men (MSM).
  • Injection drug users (IDUs).
  • Women who have sex with MSM or IDUs.
  • Individuals with recurrent sexually transmitted infections.

It is preferable that persons at increased risk seek HIV testing from clinics and medical providers so that additional support can be provided, including information and tools for risk reduction and services for linking individuals to care and follow-up.

OraQuick In-Home Test
The U.S. Food and Drug Administration approved the OraQuick In-Home HIV Test in July 2012. It is the first over-the-counter home-use rapid HIV test kit to detect the presence of antibodies to HIV-1 and HIV-2. The In-Home HIV Test kit allows individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. A positive result with this test is preliminary and requires additional confirmatory testing in a health care setting.

Test Performance
Test performance data for the OraQuick In-Home HIV Test is summarized in the following table.

Results from OraQuick InHome HIV Test
Phase III Clinical Studies

Criteria

Value

95% CI

  Sensitivity

92.98%

86.6496.92%

  False Negative : True Positive Ratio

1 : 13

 

  Specificity

99.98%

99.90100.0%

  False Positive : True Negative Ratio

1 : 3,750

 

  Accuracy

99.84%

99.6999.93%

  Positive-predictive value

99.07%

94.9099.98%

  Negative-predictive value

99.85%

99.7199.94%

Additional information regarding test performance for the OraQuick In-Home HIV Test is available from the FDA website.

How does the test performance of the in-home test compare to the professional version?
The OraQuick In-Home HIV Test is identical to the professional OraQuick Advance HIV1/2 Antibody Test that was approved by the Food and Drug Administration (FDA) in 2004 for use on oral fluid. However, test performance for the professional test exceeds that of the self-test due to user error. The sensitivity and specificity for the professional test are 99.3% and 99.8%, respectively, resulting in a false negative (FN) to true positive (TP) ratio of 1:140 and a false positive (FP) to true negative (TN) ratio of 1:460.

Where do I direct someone for further support and services?

Back to consumer information page

 Last Revised: August 11, 2014