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OraQuick

Demonstration of the OraQuick rapid HIV test
Owner	OraSure Technologies
Introduced	2002
Website	oraquick.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]

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]

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]

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]

• Official website