FAQ's for Blood Borne Virus Screening

Q. What is OraSure^® and how does Orasure^® Work?

A. The OraSure^® oral specimen collection device is an FDA validated non-invasive antibody test. This test extracts antibodies from the blood vessels in the mucous membranes in the mouth and IS NOT a saliva test. Like a blood test, OraSure^® looks for antibodies, not the virus itself. The OraSure^® ELISA test was FDA approved in December of 1994, and the Western blot confirmatory test was approved in June of 1996 for HIV. Both the OraSure^® ELISA and Western blot tests are approved for physician, medical center, or public health use; it is not licensed for at-home use.


Q. Is this test as good as the blood tests that have been in use for years?

A. A correctly performed OraSure^® Oral Fluid Antibody Test is an accurate alternative to blood testing for infection screening in public health and clinical settings.


Q. How can the OraSure^® test look for HIV in the mouth if HIV can't be transmitted through saliva and kissing?

A. OraSure^® looks for antibodies for HIV, not the virus itself. A blood test works the same way. OraSure^® does not use saliva, but rather collects antibodies directly from the blood vessels in the mucous membranes.

The OraSure^® test is not a saliva test. OraSure^® draws out HIV antibodies, if they are present, from the tissues of the cheek and gum. The mucous membranes contain much higher amount of antibodies than saliva.


Q. Do any medications or mouth conditions affect the test?

A. No. Oral conditions, disease, medications, and non related medical conditions will not affect the accuracy of the OraSure^® test.


Q. Are there any toxic chemicals in the collection pad device?

A. No. The collection device is not considered to be or contain hazardous chemicals based on evaluations made by OraSure^® Technologies, Inc. under OSHA Hazard Communications Standard, 29 C.F.R. 1910.1200. The specific ingredients are:

	Collection Pad:		Preservative Fluid:
	sodium chloride		chlorhexidine digluconate
	citric acid		Flag Blue dye
	sodium benzoate		Tween 20
	potassium sorbate		deionized water
	gelatin
	sodium hydroxide to pH to 6.5
	deionized water
	cotton pad

Q. How is OraSure^® different from viral load tests?

A. Viral load tests are blood-based tests that measure the level of virus in the bloodstream. They are used once someone knows he/she has the virus. OraSure^® accurately tests for the presence of antibodies without blood or needles.


Q. What special conditions are needed for the storage and transport of OraSure^® samples?

A. None. Once collected the sample is stable at room temperature for upto 3 weeks prior to testing. OraSure^® collection devices (both unused and collected samples) should never be stored at temperatures exceeding 98 degrees Fahrenheit. If you are using the mail to send a specimen, do not leave it in a hot mailbox for extended periods of time (i.e., over the weekend).