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OraQuick ® ADVANCE ™ HIV 1/2 Antibody Test (Oral Fluid Specimen Type)

OraQuick ® ADVANCE ™ HIV 1/2 Antibody Test (Oral Fluid Specimen Type). Blood Products Advisory Committee Meeting March 10, 2006. OraQuick ® ADVANCE ™ HIV 1/2 Test Oral Fluid Application. SIMPLE 2 STEP PROCEDURE:. Swab upper and lower gums once each with flat pad of test device .

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OraQuick ® ADVANCE ™ HIV 1/2 Antibody Test (Oral Fluid Specimen Type)

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  1. OraQuick® ADVANCE™ HIV 1/2 Antibody Test(Oral Fluid Specimen Type) Blood Products Advisory Committee Meeting March 10, 2006

  2. OraQuick®ADVANCE™ HIV 1/2 Test Oral Fluid Application SIMPLE 2 STEP PROCEDURE: Swab upper and lower gums once each with flat pad of test device Insert device in developer vial. Read result between 20 and 40 minutes

  3. OraQuick®ADVANCE™ HIV 1/2 Test Oral Fluid Application • SIMPLE RESULT • INTERPRETATION: • One line = NEGATIVE • Two lines= PRELIMINARY • POSITIVE Reactive Control Line Reactive HIV-1/2 Test Line Preliminary Positive Negative

  4. Sensitivity: 99.3% (95% CIs: 98.4%-99.9%) OraQuick®ADVANCE™ FDA Approved Performance Claims with Oral Fluid Specificity:99.8%(95% CIs: 99.6%- 99.9%)

  5. Surveillance of Post-Launch Performance of OraQuick®ADVANCE™ with Oral Fluid Two Data Sources: • Aggregate national performance in 2005 assessed using data provided by state, city health agencies, HIV/AIDS service organizations: • Data from states representing 127,323 oral fluid tests • Overall specificity: 99.8% (99.77-99.82%) • OraSure customer site survey of product performance in 2005: Data obtained from 90 customer testing sites – 43,321 oral fluid tests Overall specificity = 99.8% (99.75%-99.84%) Overall, actual field performance corresponded to product claim

  6. Investigation of Reports of False Positive Results at Particular Sites • Statistical Process Control (SPC) charting of 2005 data at 130 customer sites including those reporting high rates of false positives • Almost all 130 sites studied (96%) had specificity within expected range (95% confidence interval) • Elevated false positive rates were confined to a small number of sites • Analysis indicated a special cause operating at those sites • Product lots that were used at affected sites were also used by other sites in the same region and in other parts of the country with satisfactory performance Data suggested that site- specific factor(s) were affecting product performance at a small number of sites

  7. Suitability of Oral Fluid as a Specimen for HIV Self-Testing • Simple, non-invasive sample collection • Established clinical performance- comparable to blood/plasma testing (JAMA 2002; 288: 2960) • Published studies have indicated a preference of clients for being tested for HIV by oral fluid. (J Acquir. Immune Syndr. 2005 38: 348-355) • Independent survey of potential users indicated greater willingness to self-test with oral fluid (100%) compared to blood (64%). (OraSure Market Research; 2004)

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