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Owner | OraSure Technologies |
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Introduced | 2002 |
Website | oraquick |
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]
Chlamydia, or more specifically a chlamydia infection, is a sexually transmitted infection caused by the bacterium Chlamydia trachomatis. Most people who are infected have no symptoms. When symptoms do appear they may occur only several weeks after infection; the incubation period between exposure and being able to infect others is thought to be on the order of two to six weeks. Symptoms in women may include vaginal discharge or burning with urination. Symptoms in men may include discharge from the penis, burning with urination, or pain and swelling of one or both testicles. The infection can spread to the upper genital tract in women, causing pelvic inflammatory disease, which may result in future infertility or ectopic pregnancy.
The Mantoux test or Mendel–Mantoux test is a tool for screening for tuberculosis (TB) and for tuberculosis diagnosis. It is one of the major tuberculin skin tests used around the world, largely replacing multiple-puncture tests such as the tine test. The Heaf test, a form of tine test, was used until 2005 in the UK, when it was replaced by the Mantoux test. The Mantoux test is endorsed by the American Thoracic Society and Centers for Disease Control and Prevention. It was also used in the USSR and is now prevalent in most of the post-Soviet states, although Soviet mantoux produced many false positives due to children's allergic reaction.
HIV tests are used to detect the presence of the human immunodeficiency virus (HIV), the virus that causes HIV/AIDS, in serum, saliva, or urine. Such tests may detect antibodies, antigens, or RNA.
In immunology, seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization, including vaccination. During infection or immunization, antigens enter the blood, and the immune system begins to produce antibodies in response. Before seroconversion, the antigen itself may or may not be detectable, but the antibody is absent. During seroconversion, the antibody is present but not yet detectable. After seroconversion, the antibody is detectable by standard techniques and remains detectable unless the individual seroreverts, in a phenomenon called seroreversion, or loss of antibody detectability, which can occur due to weakening of the immune system or decreasing antibody concentrations over time. Seroconversion refers the production of specific antibodies against specific antigens, meaning that a single infection could cause multiple waves of seroconversion against different antigens. Similarly, a single antigen could cause multiple waves of seroconversion with different classes of antibodies. For example, most antigens prompt seroconversion for the IgM class of antibodies first, and subsequently the IgG class.
Post-exposure prophylaxis, also known as post-exposure prevention (PEP), is any preventive medical treatment started after exposure to a pathogen in order to prevent the infection from occurring.
Tuberculosis is diagnosed by finding Mycobacterium tuberculosis bacteria in a clinical specimen taken from the patient. While other investigations may strongly suggest tuberculosis as the diagnosis, they cannot confirm it.
Genital herpes is a herpes infection of the genitals caused by the herpes simplex virus (HSV). Most people either have no or mild symptoms and thus do not know they are infected. When symptoms do occur, they typically include small blisters that break open to form painful ulcers. Flu-like symptoms, such as fever, aching, or swollen lymph nodes, may also occur. Onset is typically around 4 days after exposure with symptoms lasting up to 4 weeks. Once infected further outbreaks may occur but are generally milder.
Rapid Stain Identification Series (RSID) is designed for fast, easy and reliable detection of human fluids from a variety of samples encountered by forensic laboratories.
The mononuclear spot test or monospot test, a form of the heterophile antibody test, is a rapid test for infectious mononucleosis due to Epstein–Barr virus (EBV). It is an improvement on the Paul–Bunnell test. The test is specific for heterophile antibodies produced by the human immune system in response to EBV infection. Commercially available test kits are 70–92% sensitive and 96–100% specific, with a lower sensitivity in the first two weeks after clinical symptoms begin.
A nontreponemal test (NTT) is a blood test for diagnosis of infection with syphilis. Nontreponemal tests are an indirect method in that they detect biomarkers that are released during cellular damage that occurs from the syphilis spirochete. In contrast, treponemal tests look for antibodies that are a direct result of the infection thus, anti-treponeme IgG, IgM and to a lesser degree IgA. Nontreponemal tests are screening tests, very rapid and relatively simple, but need to be confirmed by treponemal tests. Centers for Disease Control and Prevention (CDC)-approved standard tests include the VDRL test, the rapid plasma reagin (RPR) test, the unheated serum reagin (USR) test, and the toluidine red unheated serum test (TRUST). These have mostly replaced the first nontreponemal test, the Wassermann test.
OraSure Technologies, Inc. is a Bethlehem, Pennsylvania–based company in the medical device industry. Their products include diagnostic testing kits. The company had recently developed OraQuick testing kit, the first over-the-counter home HIV test.
DiaSorin S.p.A. is an Italian multinational biotechnology company that produces and markets in vitro diagnostics reagent kits used in immunodiagnostics and molecular diagnostics and since July 2021, it is also active in the Life Science business. The group was founded in 2000 and is headquartered in Saluggia, Italy. Its production is at several plants located in Europe and the United States: Saluggia and Gerenzano (Italy), Dietzenbach (Germany), Stillwater, Minnesota (US), Dartford (UK). Following the acquisition of Luminex, the company acquired five additional production plants located in the United States and in Canada (Toronto). The company is a constituent of the FTSE MIB index.
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