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OraQuick

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OraQuick
Demonstration of the OraQuick rapid HIV test
OwnerOraSure Technologies
Introduced2002
Websiteoraquick.com

OraQuick is an at-home HIV test manufactured by Orasure Technologies that was approved by the United States Food and Drug Administration for use by medical professionals in 2002[1][2] and for at-home use in 2012.[3][4] It is one of only two at-home HIV tests available.[5] OraQuick can be purchased by anyone above aged 17 over-the-counter at any major retail stores or online.[4][6]

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.[4]

OraQuick measures the HIV antibodies in oral fluid, but not saliva.[7][8] 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.[9][10]

History

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On November 7, 2002, the FDA approved the OraQuick test as the first rapid HIV test, providing results in as little as 20 minutes using whole-blood specimens obtained from a fingerstick or venipuncture. Prior to this approval, HIV tests required blood samples to be sent to a laboratory, resulting in longer wait times for results.[1][2] In 2004, the FDA expanded its use to include oral fluid samples, improving accessibility for individuals hesitant to undergo blood testing.[11] In July 2012, the test received approval for over-the-counter use, allowing individuals to perform it at home with a mouth swab.[3]

Principle

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The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay that can be purchased over-the-counter (OTC). This test kit contains a test swab that collects oral fluid containing antibodies for HIV-1 and HIV-2 from the user’s gums. The material is gathered and combined with buffered developer solution in a test tube. After 20 to 40 minutes, the mixture moves up the test strip, and the findings are visible. 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. [12]

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.[8][12] 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.[13] 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.[7][8] 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.[4]

Accuracy

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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%).[10] OraQuick testing generated a positive result 88 times out of 96 times that laboratory testing generated a positive result (91.7%).[10] Researchers saw subjects failed to obtain any test result 56 times in 5,055 instances (1.1%).[10] 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.[14] 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.[14]

False positives

Lyme disease, syphilis, lupus, and other conditions can contribute to false positive results.[14]

False negatives

Testing too soon after exposure (window period), low antibody levels, antiviral therapy, and testing within 30 minutes of eating or drinking can all contribute to false negative results.[14]

References

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  1. ^ a b "Approval of a new rapid test for HIV antibody". Morbidity and Mortality Weekly Report. 51 (46): 1051–2. November 2002. PMID 12487529.
  2. ^ a b O'Rourke M, Branson B, del Rio C, Larrabee S, Sax PE (March 2003). "Rapid fingerstick testing: a new era in HIV diagnostics". AIDS Clinical Care. 15 (3): 19–23, 30. PMID 12685418.
  3. ^ a b McNeil, Donald G. Jr. (3 July 2012). "OraQuick At-Home H.I.V. Test Wins F.D.A. Approval". The New York Times. Retrieved 14 November 2024.
  4. ^ a b c d 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.
  5. ^ "Home Tests | HIV Testing | HIV/AIDS | CDC". www.cdc.gov. 2017-03-21. Retrieved 2018-11-08.
  6. ^ "Where to Buy OraQuick In Home HIV Test Kits". www.oraquick.com. Retrieved 2018-10-29.
  7. ^ a b "HIV Testing | HIV/AIDS | CDC". www.cdc.gov. 2018-06-26. Retrieved 2018-10-28.
  8. ^ a b c "How Oral HIV Testing Works | OraQuick In Home HIV Test". www.oraquick.com. Retrieved 2018-10-28.
  9. ^ "OraQuick Video for In Home HIV Test Kit". www.oraquick.com. Retrieved 2018-10-29.
  10. ^ a b c d "OraQuick Results for In Home HIV Testing". www.oraquick.com. Archived from the original on 2018-10-11. Retrieved 2018-10-29.
  11. ^ "FDA Approves First Oral Fluid Based Rapid HIV Test Kit". ScienceDaily. 4 March 2004. Retrieved 14 November 2024.
  12. ^ a b "Package Insert - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, OraSure Technologies", "US Food and Drug Administration", Retrieved 2018-11-01
  13. ^ "Information regarding the OraQuick In-Home HIV Test", US Food and Drug Administration, Retrieved 2018-11-01
  14. ^ a b c d "HIV FAQ | OraQuick Home HIV Test". Archived from the original on 2019-07-30. Retrieved 2018-11-21.
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