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

Blood Products Advisory Committee Meeting

March 10, 2006

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OraQuickOraQuick®® ADVANCEADVANCE™ ™ HIV 1/2 Test HIV 1/2 Test Oral Fluid ApplicationOral Fluid Application

Swab upper and lower gums once each with flat pad of test device

Insert device in developer vial. Read resultbetween 20 and 40 minutes

SIMPLE 2 STEP PROCEDURE:

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Negative

Reactive Control

Line

SIMPLE RESULT INTERPRETATION:

One line = NEGATIVE

Two lines= PRELIMINARYPOSITIVE

Preliminary Positive

Reactive HIV-1/2

Test Line

OraQuickOraQuick®® ADVANCEADVANCE™ ™ HIV 1/2 Test HIV 1/2 Test Oral Fluid ApplicationOral Fluid Application

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Sensitivity: Sensitivity: 99.3%99.3% (95% CIs: 98.4%-99.9%) (95% CIs: 98.4%-99.9%)

Specificity:Specificity: 99.8%99.8% (95% CIs: 99.6%- 99.9%)(95% CIs: 99.6%- 99.9%)

OraQuickOraQuick®® ADVANCEADVANCE™™ FDA FDA Approved Performance Claims Approved Performance Claims with Oral Fluidwith Oral Fluid

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Surveillance of Post-Launch Surveillance of Post-Launch Performance of OraQuickPerformance of OraQuick®® ADVANCEADVANCE™™ with Oral Fluid 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

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Investigation of Reports of False Investigation of Reports of False Positive Results at Particular SitesPositive 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

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Suitability of Oral Fluid as a Suitability of Oral Fluid as a Specimen for HIV Self-Testing 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)