Medicine:OraQuick

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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

On November 7, 2002, the FDA approved the OraQuick test as the first rapid point-of-care 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

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

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

  1. ↑ 1.0 1.1 Centers for Disease Control and Prevention (CDC) (November 2002). "Approval of a new rapid test for HIV antibody". Morbidity and Mortality Weekly Report 51 (46): 1051–2. PMID 12487529. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5146a5.htm. 
  2. ↑ 2.0 2.1 "Rapid fingerstick testing: a new era in HIV diagnostics". AIDS Clinical Care 15 (3): 19–23, 30. March 2003. PMID 12685418. https://www.jwatch.org/ac200303010000001/2003/03/01/rapid-fingerstick-testing-new-era-hiv. 
  3. ↑ 3.0 3.1 McNeil, Donald G. Jr. (3 July 2012). "OraQuick At-Home H.I.V. Test Wins F.D.A. Approval". https://www.nytimes.com/2012/07/04/health/oraquick-at-home-hiv-test-wins-fda-approval.html. 
  4. ↑ 4.0 4.1 4.2 4.3 Research, Center for Biologics Evaluation and. "Consumer Updates - First Rapid Home-Use HIV Kit Approved for Self-Testing" (in en). https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm310545.htm. 
  5. ↑ "Home Tests | HIV Testing | HIV/AIDS | CDC" (in en-us). 2017-03-21. https://www.cdc.gov/hiv/testing/hometests.html. 
  6. ↑ "Where to Buy OraQuick In Home HIV Test Kits". http://www.oraquick.com/where-to-buy. 
  7. ↑ 7.0 7.1 "HIV Testing | HIV/AIDS | CDC" (in en-us). 2018-06-26. https://www.cdc.gov/hiv/testing/index.html. 
  8. ↑ 8.0 8.1 8.2 "How Oral HIV Testing Works | OraQuick In Home HIV Test". http://www.oraquick.com/What-is-OraQuick/How-Oral-Testing-Works. 
  9. ↑ "OraQuick Video for In Home HIV Test Kit". http://www.oraquick.com/Taking-the-Test/How-To-Video. 
  10. ↑ 10.0 10.1 10.2 10.3 "OraQuick Results for In Home HIV Testing". http://www.oraquick.com/Taking-the-Test/Understanding-Your-Results. 
  11. ↑ "FDA Approves First Oral Fluid Based Rapid HIV Test Kit". 4 March 2004. https://www.sciencedaily.com/releases/2004/03/040329073624.htm. 
  12. ↑ 12.0 12.1 "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. ↑ 14.0 14.1 14.2 14.3 "HIV FAQ | OraQuick Home HIV Test". http://www.oraquick.com/FAQs. 



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