The following are frequently asked questions about OraSure Technologies' OraQuick ADVANCE ®, Rapid HIV-1/2 Antibody Test. For additional information, please contact Customer Care .
When correctly performed, the OraQuick ADVANCE ®, Rapid HIV-1/2 Antibody Test provides an accurate alternative to lab-based testing for HIV infection in public health and clinical settings.
CLIA stands for Clinical Laboratory Improvement Amendments of 1988. Under CLIA, the FDA categorizes HIV tests as waived, moderate or high complexity. Tests classified as moderate or high complexity are subject to certain regulatory requirements and are performed predominantly in hospital or reference laboratories. In contrast, a CLIA-waived product is deemed so simple that an error is unlikely, so testing may be performed outside of a laboratory setting. Waived tests are conducted in many point-of-care settings including physician offices and outreach settings.
This is critically important for several reasons, including the fact that it enables paraprofessionals and nurses to administer the test, and it also enables testing in non-traditional settings, such as mobile testing vans and door-to-door outreach campaigns.
All rapid assays as well as lab-based EIA tests are used as screening tests. In the US, all preliminary positive screening tests must be confirmed with a more sensitive confirmatory assay, usually a Western blot.
A Reactive test result means that HIV antibodies may have been detected in the specimen. The test is interpreted as preliminary positive. As with all screening tests, the results must be confirmed by another method, known as a confirmatory test.
A Non-Reactive test means that anti-HIV antibodies were not detected in the specimen. This test result is interpreted as Negative.
A Non-Reactive (negative) test means that anti-HIV antibodies were not detected in the specimen. This test result is interpreted as Negative.
It is possible to get a negative screening test if the infection is very recent. This may be because there is a window period of several weeks when a person may be infected but antibodies to the virus have not reached a concentration that is visible. Therefore, if a person has certain risk factors, or thinks they may have been exposed to HIV, they should be retested in three months to be certain of a negative result.
A false-positive is when a test returns a preliminary positive result that is later determined (through a confirmatory test) to be inaccurate. False-positives are rare, but are a natural and expected occurrence with all diagnostic products, including pregnancy tests, cholesterol tests and cancer tests.
The CDC has determined, and multiple supporting studies confirm, that HIV transmission does not occur through saliva. However, the OraQuick ADVANCE ®, HIV-1/2 Test does not use saliva, but rather absorbs antibodies directly from the blood vessels in the mucous membranes of the mouth. OraQuick ADVANCE ®, detects antibodies for HIV, not the virus itself.
The test draws out HIV antibodies, if they are present, from the tissues of the cheek and gum. The mucous membranes have a much higher amount of antibodies than saliva.
Viral load tests are blood-based tests that measure the level of HIV virus in the bloodstream. They are used once someone already knows he/she has the virus. OraQuick ADVANCE ®, HIV-1/2 Test accurately detects the presence of HIV antibodies and is used to identify infected persons.
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.
Yes. The OraQuick ADVANCE ®, Rapid HIV-1/2 Antibody Test should never be stored at temperatures exceeding 80°,F.
The information provided on this website is intended only for the residents of the United States. The products discussed herein may have different labeling in different countries and may not be for sale in all other countries.
Page last updated:November 21, 2012
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