On March 26, 2004, the U.S. Food and Drug Administration (FDA) approved the first rapid diagnostic test for HIV, the virus that causes AIDS, that uses oral fluid samples rather than blood. Manufactured by OraSure Technologies, Inc., it is the same test method as their recently approved OraQuick Rapid HIV-1/2 Antibody Blood Test, but uses oral fluid (saliva) rather than blood from a fingerstick. It is estimated to be 99% accurate.
The test is simple to perform. Oral fluid is collected using an absorbent pad, which is used to wipe the outer gums. The pad is then inserted into a device and is treated with a solution that can detect antibodies to the virus. Colored bands appear in a window. One line indicates the test system is working properly. A second line indicates that HIV-1 antibodies are detected. Results can be available in 20 minutes.
This rapid turnaround time may improve the awareness of people’s HIV status since many people who are screened by traditional tests never return for follow-up visits to get their results. (These traditional tests may take days or weeks to get results.) Although the new test using oral fluid is currently approved for use only in laboratories, it is expected to receive a CLIA (Clinical Laboratory Improvements Amendments of 1988) waiver, like the fingerstick rapid test has, so that it can be used in other health care settings, such as clinics, which will increase its availability.
The oral fluid rapid screening test has slightly lower sensitivity and specificity than the fingerstick blood test, and it has been approved for use in detecting HIV-1 antibodies only, not HIV-2 antibodies. (HIV-2 is rare in the U.S. where most people infected by HIV are infected with the HIV-1 type of virus). Nevertheless, it offers several distinct advantages. The oral fluid rapid test provides a more appealing option to those test takers who do not like to have their blood drawn or finger stuck with a lancet. In addition, this test will help to reduce the risk of transmission of the virus to health care workers since HIV can be contracted through handling blood, but no cases of transmission through handling saliva have been documented.
As is the case with the fingerstick method, results using the oral fluid method should be confirmed by another, more specific method.
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