Oral Fluid Collection Training
We use a specially treated cotton fiber pad attached to a nylon stick which is placed between the lower cheek and gum and left for 2-5 minutes. The collection pad draws IgG antibodies out of the tissues of the cheek and gum. This sample, called oral mucosal transudate, contains far fewer contaminants than typically found in saliva. If present, antibodies to the HIV-1 virus will be collected in this sample.
The pad is then placed in the transport vial. This vial contains preservative which will keep the sample stable for up to 21 days at 39° F to 98° F. The sample is then sent to ExamOne for analysis.
The tests performed at the laboratory test for antibodies to the HIV-1 virus, not the virus itself. This is why we can test for HIV-1, but the virus is not known to be transmittable through oral fluids.
Our oral fluid collection device is intended for use in the collection of oral fluid specimens for testing for antibodies to the Human Immunodeficiency Virus – Type 1 (HIV-1) in subjects 13 years of age and older.
Restrictions: The administration of this device is restricted to individuals who have been trained on the use of this device. The device is not to be provided to subjects for home use. Subjects must be provided with the “Testing for HIV Antibodies” pamphlet.
Testing of oral fluid specimens is restricted to testing with the Avioq HIV-1 Microelisa System manufactured by Avioq Inc. and the OraSure HIV-1 Western Blot Kit manufactured by OraSure Technologies, Inc. The OraSure HIV-1 device is restricted to use for diagnostic purposes and must not be used to screen blood donors.
Important Notes: If a specimen test is repeatedly reactive with the Oral Fluid Avioq HIV-1 Microelisa System, that specimen should be further tested for HIV-1. Specimens should be properly handled, shipped and stored. See package insert for complete information.