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FDA approves first over-the-counter HIV test kit for home use

Robin Wulffson MD's picture
HIV, AIDS, test, over-the-counter, FDA, OraSure Technologies. OraQuick

On July 3, the Food and Drug Administration (FDA) announced the approval of an over-the-counter test kit for human immunodeficiency virus (HIV).The kit will allow anyone concerned about the possibility of acquiring the infection a simple means to check for the virus without presenting to a healthcare facility.

The OraQuick In-Home HIV Test can detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). The test kit, manufactured by OraSure Technologies, Inc. (Bethlehem, Pensylvania), is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths. The swab is then placed into a developer vial; the results appear within 20 to 40 minutes.

A positive result with this test does not mean that an individual is definitely infected with HIV; however, it indicates that additional testing should be done in a medical setting to confirm the test result. Also of note, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months. Despite the foregoing, the FDA asserts that the test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.

The Centers for Disease Control and Prevention (CDC) estimates that 1.2 million people in the United States are living with HIV infection. About one in five are not aware they are infected. There are about 50,000 new HIV infections every year. Many of these new infections are transmitted from people who are unaware of their HIV status. “Knowing your status is an important factor in the effort to prevent the spread of HIV,” noted Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”

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Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92% for test sensitivity, the percentage of results that will be positive when HIV is present. This means that one false negative result would be expected out of every 12 test results in HIV-infected individuals. Clinical studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98% for test specificity, the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in uninfected individuals.

OraSure Technologies will have a consumer support center that is available via phone and will be open 24 hours a day, seven days a week. The center will be operational and available to educate users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained once the manufacturer makes the product available for sale to the public. Information about the consumer support center and contact information is included in the test kit.

HIV has spread throughout the US. The disease is more prevalent in urban areas, especially in inner cities. The virus can be spread by the following:

  • Contaminated blood transfusions and blood products
  • Intimate sexual contact
  • The use of contaminated needles and syringes

The virus may also spread from a mother to her infant, either at birth or through breastfeeding. Individuals who become infected with HIV may have no symptoms for up to 10 years; however, they can still pass the infection to others. After being exposed to the virus, it usually takes about three months for the HIV ELISA blood test to change from HIV negative to HIV positive.

Symptoms related to HIV are usually due to an infection in part of the body. Some symptoms related to HIV infection include:

  • Diarrhea
  • Fatigue
  • Fever
  • Frequent vaginal yeast infections
  • Headache
  • Mouth sores, including fungal (candida) infection
  • Muscular stiffness or aching
  • Rash of various types, including seborrheic dermatitis
  • Sore throat
  • Swollen lymph glands

Reference: FDA