OraQuick

OraQuick is an at-home HIV test manufactured by Orasure Technologies that was approved by the United States Food and Drug Administration in 2012.[1] It is one of only two at-home HIV tests available.[2] OraQuick can be purchased by anyone above aged 17 over-the-counter at any major retail stores or online.[1][3]

OraQuick
Demonstration of the OraQuick rapid HIV test
OwnerOraSure Technologies
Introduced2012
Websiteoraquick.com

As of November 2018, the testing kit costs on average about $40-45. The United States Food and Drug Administration states that even though an individual can use the HIV test kit as a primary test measure, it is still important to see a medical professional for secondary testing.[1]

OraQuick measures the HIV antibodies in oral fluid, but not saliva.[4][5] The test kit contains an oral swab attached to the reader, and a fluid-filled test tube. The test results can either be invalid, positive, or negative.[6][7]

Principle

The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay that can be purchased over-the-counter (OTC). The test kit contains a test swab that collects oral fluid containing antibodies for HIV-1 and HIV-2 from the user’s gums. The specimen is collected in a test tube and mixed with buffered developer solution. The mixture travels up the test strip, and results appear after 20-40 minutes. The C-Line indicates that the mixture is migrating up the test strip adequately and the test is properly working. The T-Line contains antigens immobilized on a nitrocellulose membrane that HIV antibodies can react to. [8]

If a dark C-Line appears, then the test is working. The results are negative if only a C-Line is present. The results are positive if both a C-Line and T-Line appear.[5][8] Since a positive result does not necessarily indicate HIV-positive status, a follow-up test should be done in a medical setting to confirm the test results.[9] An initial positive result is not a definitive HIV diagnosis, but rather it should prompt the user to seek immediate medical attention for HIV blood tests and follow-ups.[4][5] A negative result indicates no HIV infection, but the test cannot accurately detect HIV levels when exposure was within the past 3 months. Even then, there can still be false negatives.[1]

Accuracy

Testing performance

In a clinical study, trained professionals compared HIV test results of OraQuick In-Home HIV Test with results from laboratory testing. The study was conducted on 4,999 participants and found OraQuick testing correctly generated a negative result 4,902 times out of the 4,903 times laboratory testing generated a negative result (99.9%).[7] OraQuick testing generated a positive result 88 times out of 96 times that laboratory testing generated a positive result (91.7%). [7] Researchers saw subjects failed to obtain any test result 56 times in 5,055 instances (1.1%).[7] OraQuick In-Home HIV Testing is expected to provide accurate results at 3 months from exposure since this is the amount of time it takes for people to develop antibodies to HIV.[10] A negative test result does not confirm individuals are not infected by HIV. There is a window period of approximately 3 months when individuals are still not producing enough antibodies to generate a positive result, thus it is recommended to test regularly. [10]

False positives

Lyme disease, syphilis, lupus, and other conditions can contribute to false positive results.[10]

False negatives

Testing too soon after exposure, low antibody levels, antiviral therapy, and testing within 30 minutes of eating or drinking can all contribute to false negative results.[10]

References
  1. Research, Center for Biologics Evaluation and. "Consumer Updates - First Rapid Home-Use HIV Kit Approved for Self-Testing". www.fda.gov. Retrieved 2018-11-01.
  2. "Home Tests | HIV Testing | HIV/AIDS | CDC". www.cdc.gov. 2017-03-21. Retrieved 2018-11-08.
  3. "Where to Buy OraQuick In Home HIV Test Kits". www.oraquick.com. Retrieved 2018-10-29.
  4. "HIV Testing | HIV/AIDS | CDC". www.cdc.gov. 2018-06-26. Retrieved 2018-10-28.
  5. "How Oral HIV Testing Works | OraQuick In Home HIV Test". www.oraquick.com. Retrieved 2018-10-28.
  6. "OraQuick Video for In Home HIV Test Kit". www.oraquick.com. Retrieved 2018-10-29.
  7. "OraQuick Results for In Home HIV Testing". www.oraquick.com. Retrieved 2018-10-29.
  8. "Package Insert - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, OraSure Technologies", "US Food and Drug Administration", Retrieved 2018-11-01
  9. "Information regarding the OraQuick In-Home HIV Test", US Food and Drug Administration, Retrieved 2018-11-01
  10. "HIV FAQ | OraQuick Home HIV Test".
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