OraQuick

OraQuick is an at-home HIV test manufactured by Orasure Technologies and approved by the United States Food and Drug Administration in 2012.[1] It is one of the two at-home HIV tests available with the other one named Home Access HIV-1 Test System.[2] OraQuick can be purchased by anyone above aged 17 over-the-counter at any major retail stores, like CVS or Target, or online.[1][3] 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
Demonstration of the OraQuick rapid HIV test
OwnerOraSure Technologies
Introduced2012
Websiteoraquick.com

Unlike other HIV tests that measures HIV virus or HIV antigens from blood, OraQuick measures the HIV antibodies in oral fluid, (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 into a test tube and is 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]

Test procedures

The test is performed as follows:[6]

  1. After opening the kit, run the oral swab across the upper and lower gums once.
  2. Insert the swab into the fluid-filled test tube and mark the time.
  3. After 20 minutes, the results will appear as "lines" on the reader, which the user can then begin reading. Results are inaccurate if 40 minutes have passed since the start time.

Results

Reading results

The test stick has two letters: "C" and "T", and lines would appear as the test is running.[6][7]

  • 0 line - Invalid: A line next to "C" indicates the test is working. If there is no line next to the "C", the test kit is defective and the result is invalid.
  • 1 line - Negative: A line next to "C" but not "T" indicates a negative result.
  • 2 lines - Positive: A line next to "C" and "T" indicate a positive result.

Interpretation
  • 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] All OraQuick In-Home HIV testing that is reported positive should be followed-up with more specific confirmatory testing such as Western blot. Western blot can distinguish between HIV antibodies and other antibodies that may also lead to false positive results.

Negative OraQuick In-Home HIV test results does not confirm individuals are not infected by HIV. There is a window period of approximately 3 months where individuals are still 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 from the time of exposure, low antibody levels, antiviral therapy, and testing within 30 minutes from eating or drinking can all contribute to false negative results.[10]

Comparison with Home Access HIV-1 Test System

The HIV-1 Test System is the other at-home HIV test. Both OraQuick and HIV-1 Test System provide confidential counseling and treatment referrals. The main differences are that OraQuick does not require blood and presents results within 40 minutes, whereas Home Access HIV-1 Test System requires mailing a blood sample to a laboratory which would then have results available anonymously via telephone within 3 to 7 business days.[11] The laboratory would also do an automatic follow-up test if the initial result was positive, also included in the reports.

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".
  11. Research, Center for Biologics Evaluation and. "Premarket Approvals (PMAs) - Information regarding the Home Access HIV-1 Test System". www.fda.gov. Retrieved 2018-11-08.
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