OraSure® HIV-1 Oral Specimen Collection Device

OraSure® HIV-1 Oral Specimen Collection Device enables the collection of an oral fluid sample for use with a lab-based screening test that is used for detecting the HIV-1 virus.

Oral fluid testing provides samples that are easier to deal with than blood collections. With oral testing, insurance companies can identify HIV-1 status, providing assessment to the behavior and health status of applicants. The benefits that insurance companies see with oral fluid testing include: faster test results, less underwriting time, significant cost savings, reduction of "not takens" and an applicant- and agent-friendly experience.

  • Easy-to-Administer
    Provides a fast and easy method for sample collection, enabling non-medical professionals, such as insurance agents, to collect samples for laboratory processing.
  • Fast and Simple Collection
    The patient places the OraSure® device between the lower cheek and gum for 2-5 minutes. The pad draws oral fluid, which is rich in antibodies and contains far fewer contaminants than typically found in saliva. The pad is transported to a lab in a vial that contains preservatives, which stabilize the sample for up to 21 days at 39° F to 98° F.
  • Patient-Preferred
    Offers patients accurate testing without the need for blood samples or needles, providing more comfortable testing.

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Collection Procedure

Please see package insert for complete instructions.

Step 1 - Collect Sample

Step 1: Collect sample

Place the pad between the cheek and gum for 2-5 minutes.

Step 2 - Insert the device into the buffer

Step 2: Insert the device into the buffer

Snap off the wand. Replace the cap and send to the lab via regular mail with the completed Laboratory Informed Consent Form.

Step 3: Lab Testing

The lab processes the sample and runs a screening enzyme immunoassay (EIA) test. Results presented in one day after sample is received by lab.

OraSure® HIV-1 Oral Specimen Collection Device FAQs

The following are frequently asked questions about OraSure Technologies' OraSure® HIV-1 Oral Specimen Collection Device. For additional information, please contact Customer Care.

  1. What is OraSure® HIV-1 and how does it work?
  2. Is this test as good as the blood tests that have been in use for years?
  3. Is HIV transmitted through saliva? How can you test for HIV using oral fluid if HIV cannot be transmitted through saliva and kissing?
  4. Do any medications or mouth conditions affect the test?
  5. Are there any toxic chemicals in the collection pad device?
  6. How is OraSure® HIV-1 different from viral load tests?
  7. Is there any thing related to temperature that I should know about storing OraSure® HIV tests?
  1. What is OraSure® HIV-1 and how does it work?
    The OraSure® HIV-1 Oral Specimen Collection Device is an FDA approved non-invasive collector of oral fluid specimens for the detection of HIV-1 antibodies. This device is restricted for trained individuals (e.g. insurance agents, public health counselors, etc.) and not licensed for at-home use.

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  2. Is this test as good as the blood tests that have been in use for years?
    When correctly performed, OraSure® Oral Fluid HIV-1 Antibody Test is an accurate alternative to blood testing for HIV-1 infection in the insurance industry.

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  3. Is HIV transmitted through saliva? How can you test for HIV using oral fluid if HIV cannot be transmitted through saliva and kissing?
    The CDC has determined, and multiple supporting studies confirm, that HIV transmission does not occur through saliva. However, the OraSure® HIV-1 Oral Collection Device does not use saliva, but rather absorbs antibodies directly from the blood vessels in the mucous membranes of the mouth. OraSure® HIV-1 Oral Collection Device detects antibodies for HIV, not the virus itself.

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  4. Do any medications or mouth conditions affect the test?
    No. Oral conditions, disease, medications, and non-HIV related medical conditions will not affect the accuracy of the OraSure® HIV-1 oral specimen or the enzyme immunoassay (EIA) performed with the collected specimen.

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  5. Are there any toxic chemicals in the collection pad device?
    No. The collection device is not considered to be hazardous and does not contain hazardous chemicals, based on evaluations made by OraSure Technologies, Inc. under OSHA Hazard Communications Standard, 29 C.F.R. 1910.1200.

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  6. How is OraSure® HIV-1 different from viral load tests?
    Viral load tests are blood-based tests that measure the level of HIV virus in the bloodstream. They are used once someone knows he/she has the virus. OraSure® HIV-1 accurately detects the presence of HIV antibodies and is used to identify infected persons.

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  7. Is there any thing related to temperature that I should know about storing OraSure® HIV tests?
    Yes. OraSure® collection devices (both unused and collected samples) should never be stored at temperatures exceeding 98°F. Use insulated coolers or cold packs if you anticipate temperatures to be higher than 98°F.

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OraSure® HIV-1 Oral Specimen Collection Device Resources

OraSure® HIV-1 Oral Specimen Collection Device Subject Information Pamphlet

OraSure® HIV-1 Oral Specimen Collection Device Material Safety Data Sheets (MSDS)

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