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Oral HIV Self-Testing
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Information for Health Care Providers
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your information and for the benefit of the general public. The Department
of Health Services does not testify to, sponsor, or endorse the
accuracy of the information provided on externally linked pages.
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.
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Results from OraQuick®
InHome HIV Test
Phase III Clinical Studies |
|
Criteria |
Value |
95% CI |
|
Sensitivity |
92.98% |
86.64–96.92% |
|
False Negative : True Positive Ratio |
1
: 13 |
|
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Specificity |
99.98% |
99.90–100.0% |
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False Positive : True Negative Ratio |
1
: 3,750 |
|
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Accuracy |
99.84% |
99.69–99.93% |
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Positive-predictive value |
99.07% |
94.90–99.98% |
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Negative-predictive value |
99.85% |
99.71–99.94% |
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
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Last Revised:
October 04, 2012
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