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OraQuick
OraQuick is an at-home HIV test manufactured by OraSure Technologies, Orasure Technologies that was approved by the United States Food and Drug Administration in 2012. It is one of only two at-home HIV tests available. OraQuick can be purchased by anyone above aged 17 over-the-counter at any major retail stores or online. 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. OraQuick measures the HIV antibodies in oral fluid, but not saliva. 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. Principle The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay that can be purchased Over-the-counter drug, over-the-counter (O ...
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Oraquick
OraQuick is an at-home HIV test manufactured by OraSure Technologies, Orasure Technologies that was approved by the United States Food and Drug Administration in 2012. It is one of only two at-home HIV tests available. OraQuick can be purchased by anyone above aged 17 over-the-counter at any major retail stores or online. 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. OraQuick measures the HIV antibodies in oral fluid, but not saliva. 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. Principle The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay that can be purchased Over-the-counter drug, over-the-counter (O ...
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OraSure Technologies
OraSure Technologies 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. History OraSure was founded in 1988 by Sam Niedbala, Mike Gausling and two others as SolarCare Technologies Corp. In 2000, the company merged with Epitope, a company that had developed a way of testing for HIV. After the merger, the company became OraSure. In 2004, founder Sam Niedbala retired from the company. In response to the COVID-19 pandemic, OraSure expanded the company by creating over 150 jobs in Bethlehem to work on creating a rapid, at-home coronavirus test. The company had previously developed products to rapidly check for Hepatitis C and Ebola. Products OraSure created the OraQuick test, which can detect the presence of HIV from a mouth swab within 20 minutes. In 2004, the company began marketing OraQuick to health care ...
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HIV Test
HIV tests are used to detect the presence of the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), in serum, saliva, or urine. Such tests may detect antibodies, antigens, or RNA. AIDS diagnosis AIDS is diagnosed separately from HIV. Terminology The window period is the time from infection until a test can detect any change. The average window period with HIV-1 antibody tests is 25 days for subtype B. Antigen testing cuts the window period to approximately 16 days and nucleic acid testing (NAT) further reduces this period to 12 days. Performance of medical tests is often described in terms of: * Sensitivity: The percentage of the results that will be positive when HIV is present * Specificity: The percentage of the results that will be negative when HIV is not present. All diagnostic tests have limitations, and sometimes their use may produce erroneous or questionable results. * False positive: The test incorrectly i ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ...
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Over-the-counter Drug
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The rea ..., which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures. The term ...
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Lyme Disease
Lyme disease, also known as Lyme borreliosis, is a vector-borne disease caused by the ''Borrelia'' bacterium, which is spread by ticks in the genus ''Ixodes''. The most common sign of infection is an expanding red rash, known as erythema migrans (EM), which appears at the site of the tick bite about a week afterwards. The rash is typically neither itchy nor painful. Approximately 70–80% of infected people develop a rash. Early diagnosis can be difficult. Other early symptoms may include fever, headaches and tiredness. If untreated, symptoms may include loss of the ability to move one or both sides of the face, joint pains, severe headaches with neck stiffness or heart palpitations. Months to years later repeated episodes of joint pain and swelling may occur. Occasionally shooting pains or tingling in the arms and legs may develop. Despite appropriate treatment about 10 to 20% of those affected develop joint pains, memory problems and tiredness for at least six months. Lym ...
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Syphilis
Syphilis () is a sexually transmitted infection caused by the bacterium ''Treponema pallidum'' subspecies ''pallidum''. The signs and symptoms of syphilis vary depending in which of the four stages it presents (primary, secondary, latent, and tertiary). The primary stage classically presents with a single chancre (a firm, painless, non-itchy skin ulceration usually between 1 cm and 2 cm in diameter) though there may be multiple sores. In secondary syphilis, a diffuse rash occurs, which frequently involves the palms of the hands and soles of the feet. There may also be sores in the mouth or vagina. In latent syphilis, which can last for years, there are few or no symptoms. In tertiary syphilis, there are gummas (soft, non-cancerous growths), neurological problems, or heart symptoms. Syphilis has been known as "the great imitator" as it may cause symptoms similar to many other diseases. Syphilis is most commonly spread through sexual activity. It may also be transmi ...
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Lupus
Lupus, technically known as systemic lupus erythematosus (SLE), is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body. Symptoms vary among people and may be mild to severe. Common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission during which there are few symptoms. The cause of SLE is not clear. It is thought to involve a mixture of genetics combined with environmental factors. Among identical twins, if one is affected there is a 24% chance the other one will also develop the disease. Female sex hormones, sunlight, smoking, vitamin D deficiency, and certain infections are also believed to increase a person's risk. The mechanism involves an immune response by autoantibodies against a person's own tissues. T ...
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Medical Tests
A medical test is a medical procedure performed to detect, diagnose, or monitor diseases, disease processes, susceptibility, or to determine a course of treatment. Medical tests such as, physical and visual exams, diagnostic imaging, genetic testing, chemical and cellular analysis, relating to clinical chemistry and molecular diagnostics, are typically performed in a medical setting. Types of tests By purpose Medical tests can be classified by their purposes, the most common of which are diagnosis, screening and evaluation. Diagnostic A diagnostic test is a procedure performed to confirm or determine the presence of disease in an individual suspected of having a disease, usually following the report of symptoms, or based on other medical test results. This includes posthumous diagnosis. Examples of such tests are: * Using nuclear medicine to examine a patient suspected of having a lymphoma. * Measuring the blood sugar in a person suspected of having diabetes mellitus after ...
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HIV/AIDS
Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual may not notice any symptoms, or may experience a brief period of influenza-like illness. Typically, this is followed by a prolonged incubation period with no symptoms. If the infection progresses, it interferes more with the immune system, increasing the risk of developing common infections such as tuberculosis, as well as other opportunistic infections, and tumors which are rare in people who have normal immune function. These late symptoms of infection are referred to as acquired immunodeficiency syndrome (AIDS). This stage is often also associated with unintended weight loss. HIV is spread primarily by unprotected sex (including anal and vaginal sex), contaminated blood transfusions, hypodermic needles, and from mother to ch ...
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