CBER OraQuick Rapid HIV-1 Antibody Test, OraSure Technologies, Inc
... OraQuick Rapid HIV-1 Antibody Test PMA number: BP010047 Indication for Use: Detection of HIV-1 antibodies in fingerstick whole blood specimens Approval Date: 11/7/2002 Letter (Text) Label (PDF) Summary ...
- www.fda.gov/cber/pma/p010047.htm
- 9/15/2005
CBER MedMira Reveal Rapid HIV-1 Antibody Test, MedMira Laboratories ...
... MedMira Reveal Rapid HIV-1 Antibody Test PMA number: BP000023/0 Indication for Use: Detection of antibodies to HIV-1 in human serum or plasma specimens Approval Date: 4/16/2003 Letter - (Text) Label - ...
- www.fda.gov/cber/pma/p000023.htm
Appendix: Quality Assurance Guidelines for Testing Using the ...
Appendix: Quality Assurance Guidelines for Testing Using the OraQuick Rapid HIV-1 Antibody Test Overview This appendix includes several items to facilitate conducting testing and ...
- www.cdc.gov/hiv/rapid_testing/materials/QA_Guidelines_OraQuick_Appendix.pdf
- PDF file
Notice to Readers: Approval of a New Rapid Test for HIV Antibody
... 2002, the Food and Drug Administration announced approval of the OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies, Inc., Bethlehem, Pennsylvania) for use by trained personnel as a point-of ...
- www.cdc.gov/mmwr/preview/mmwrhtml/mm5146a5.htm
- 9/15/2005
National HIV Testing Resources
... up to 20 minutes. In comparison, results from the commonly used HIV-antibody screening test, the EIA, are not available for 1-2 weeks. There are currently four rapid HIV tests licensed for use in ...
- www.hivtest.org/subindex.cfm?FuseAction=FAQ
HIV Antibody Test: The Test
... 1 Antitrypsin ALT Ammonia Amylase ANA ... AIDS test, AIDS screen, HIV serology Formal name: Human immunodeficiency ... immunodeficiency virus (HIV) antibody test email this page print this ...
- www.labtestsonline.org/understanding/analytes/hiv_antibody/test.html
HIV Antibody Test: Common Questions
... else of my test results? 5. Can you use the HIV antibody test to detect HIV in newborns? 6. Are there HIV testing methods other than a blood test? 1. What are the symptoms of HIV infection? The only ...
- www.labtestsonline.org/understanding/analytes/hiv_antibody/faq.html
HIV Antibody Assays
... infection is weak because low avidity HIV-1 antibody comprises the majority of antibodies ... the FDA licensed the first combination HIV-1/HIV-2 screening test and recommended that blood banks start ...
- hivinsite.ucsf.edu/InSite?page=kb-02-02-01
How Accurate is the HIV Antibody Test
... be used alone to report a positive final result. Q. Do the HIV antibody ELISA and HIV antibody Western blot test for HIV-1 and HIV-2? A. There are two types of HIV (HIV-1 and HIV-2). Both HIV-1 and ...
- www.managingdesire.org/hivtaccu.html
HIV & AIDS - Factors Known to Cause False Positive HIV Antibody Test ...
... HIV Antibody Test Results By ... HIV] antibody test. J. Clin. Micro. 23:381. 25. Kashala O, Marlink R, Ilunga M. et al. 1994. Infection with human immunodeficiency virus type 1 (HIV-1) and human T ...
- www.virusmyth.net/aids/data/cjtestfp.htm
- 9/15/2005