Oraquick Rapid HIV-1 Antibody Test (on-the-spot HIV test)
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Indications
Clinical significance
- HIV screening test
- results need to be confirmed by more specific test (i.e. HIV1 Western Blot)
- FDA approved for use in hospitals & clinics
- FDA approved for in home use[4][5]
Procedure
- the test uses fingerstick blood sample
- takes about 20 minutes
- a lancet draws a blood droplet which is transferred to a plastic specimen loop
- the sample is mixed with a developing solution
- a test reading device is dipped into a vial & incubated for 20 minutes
- a single pink line at the control area means the test is negative; two pink lines is a positive test (i.e. indication of HIV infection).
- the test uses a strip of HIV proteins to detect antibody
- accuracy of test is 99.6%
- anyone with simple training can administer the test
Notes
- cost $12 (2003)
- Abbott & Orasure Technologies
More general terms
Additional terms
References
- ↑ Prescriber's Letter 10(3):15 2003
- ↑ Prescriber's Letter 11(8): 2004 CLIA Waiver Granted to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200805&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Morgan D FDA panel backs OraSure's In-Home HIV test Reuters, May 15, 2012 http://news.yahoo.com/fda-panel-backs-orasures-home-hiv-test-204010520--finance.html
Federal Panel Backs Easier Home Test for H.I.V. Associated Press, May 15, 2012 http://www.nytimes.com/2012/05/16/health/research/fda-panel-backs-easier-home-hiv-test.html?_r=1
Blood Products Advisory Committee, 102nd Meeting, May 15, 2012 The Hilton Washington DC North/Gaithersburg 620 Perry Parkway Gaithersburg, Maryland, 20877 Issue Summary Topic: Safety and effectiveness of the proposed OraQuick In-Home HIV Test http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM303657.pdf - ↑ 4.0 4.1 FDA News Release: July 3, 2012 FDA approves first over-the-counter home use HIV test kit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310542.htm
- ↑ 5.0 5.1 Prescriber's Letter 19(9): 2012 OraQuick In-Home HIV Test Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=280906&pb=PRL (subscription needed) http://www.prescribersletter.com