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Oraquick Rapid HIV-1 Antibody Test (on-the-spot HIV test)

Indications: - HIV1 infection 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

Related

Orasure Rapid HIV-1 Antibody Test (on-the-spot HIV test)

General

rapid HIV test (point of care HIV test)

References

  1. Prescriber's Letter 10(3):15 2003
  2. Prescriber's Letter 11(8): 2004 CLIA Waiver Granted to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Detail-Document#: 200805 (subscription needed) http://www.prescribersletter.com
  3. 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. 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. Prescriber's Letter 19(9): 2012 OraQuick In-Home HIV Test Detail-Document#: 280906 (subscription needed) http://www.prescribersletter.com