Downloaded 13 times
Uploaded byHIVScotland
Self testing meeting glasgow reid3
This document discusses the development and use of a rapid, non-invasive at-home HIV self-test called OraQuick. It describes: 1) The need for novel testing approaches to reach more individuals who have never been tested for HIV. 2) Details of the OraQuick test, including its accuracy (>99%), ease of use involving a oral fluid sample, and 30 month shelf life. 3) Clinical trial results showing the test had a 99.8% accuracy rate when used unsupervised and identified previously undiagnosed HIV-positive individuals, though some reported incorrect negative results. 4) Support resources like a 24/7 support center to help individuals interpret results and get linked to care
More Related Content
Similar to Self testing meeting glasgow reid3
Self testing meeting glasgow reid3
- 1. Diagnosing the Undiagnosed.The development of a non invasive, rapid HIV self test Brian Reid Vice President, International OraSure Technologies Inc.
- 2. Reaching the unreachable– novel testing means •Despite widespread availability of blood tests, significant number of individuals have never had an HIV test Laboratory testing Provider based HCT Community testing Provider based In Pharmacy Home testing testing Self sampling Supervised Anonymous self self testing testing 2
- 3. OraQuick ADVANCE® RapidHIV-1/2 Antibody Test • Highly accurate (>99%) test results in 20 minutes • • • • Sensitivity: 100%* Specificity: 99.8%* Over 25 million units sold worldwide 30 month shelf life Used in diverse settings Rapid-format test that detects HIV antibodies in oral mucosal transudate (OMT) OMT contains high concentration of IgG antibodies. Confidential & Proprietary 3
- 4. Oral Fluid –Specimen Collection 4
- 5. OraQuick® In-Home HIVTestResult Interpretation SIMPLE RESULT INTERPRETATION: One line = NEGATIVE Two lines = POSITIVE* Reactive Control Line Reactive HIV-1/2 Test Line Negative Positive * Labeling describes positive result as ”you may have HIV” 5 Confidential & Proprietary
- 6. OraQuick In HomeHIV Test History Confidential & Proprietary
- 7. Challenges Maximizing Diagnostic Efficiencyof Home Tests • Bastian LA et al. (1998). Meta-analysis of home pregnancy tests: – Sixteen home pregnancy tests (5 studies) – Aggregate sensitivity in laboratory studies: 91% (84%-96%) – Aggregate sensitivity in self-test studies: 75% (0.64-0.85) • De La Fuente et al. (2012). Self-test study using fingerstick HIV test: – Only 92% of users obtained a valid result 7
- 8. OraQuick® In-Home HIVTest System – Outer Box Confidential & Proprietary 8
- 9. Label Comprehension StudyResults 98.8% Product use (self-selection) Time test can detect HIV (window period) What to do if anxious about taking the test Not okay to use under 14 years of age Okay to use if pregnant Not okay if previously diagnosed with HIV Wait 30 minutes after eating / drinking Not okay to expose to cleaning reagents Last step before timing test Minimum time test result can be read (>20 minutes) Time when test result is no longer valid (>40 minutes) What to do if test result is Positive What to do if you are not sure of your result What to do if your test result is Negative What to do if you have any questions 98.6% 97.2% 92.8% 91.8% 88.4% 96.2% 91.4% 84.6% 96.4% 98.2% 97.0% 97.4% 82.2% 99.2% Questions on self-selection Questions on performing the test Questions on interpretation of the test results Confidential & Proprietary 9
- 10. OraQuick® In-Home HIVTest System – Kit Contents Test stand Stepwise Instructions Package Insert Pre & Post-Test Informational Booklet Pouched Confidential & Proprietary Device Test Device Pouched Developer Vial 10
- 11. Phase III Trial:Unobserved Self-Testing Study • Visit 1: Subject enrolled and blood drawn for lab testing • Visit 2: Subject self selected (or de-selected) and took possession of OraQuick In-Home HIV Test kit • Visit 3: Subject returned to site and provided self-test result according to standard script – Site staff provided laboratory results to the subject – Appropriate counseling was provided based on laboratory results – Additional information collected on subject intent • Visit 4: Scheduled if required based on follow-up testing • Cross sectional demographics Confidential & Proprietary 11
- 12. Performance of theIn-Home HIV test in the Hands of the Consumer (Phase III Study of Unobserved Self-Testing) Accuracy (4990/4999) Test System Failure Rate* (56/5055) Sensitivity (88/96)** Specificity (4902/4903) NPV (4902/4910) PPV (88/89) 99.82% (95% CI: 99.66% - 99.92%) 1.11% (95% CI: 0.84% - 1.44%) 91.67% (95% CI: 84.24% - 96.33%) 99.98% (95% CI: 99.89% - 100.0%) 99.84% (95% CI: 99.68% – 99.93%) 98.88% (95% CI: 93.90% - 99.97%) *Proportion of tests that user failed to get a positive or negative result ** Eight HIV positive individuals reported their HIV self-test result as negative 12 Confidential & Proprietary
- 13. Percentage Intention Responses: HIVPositive Subjects 100 90 80 70 60 50 40 30 20 10 0 0 Not at all likely 1 2 3 4 Definitely Scale of 0 to 4 Likelihood to get post-test counseling (N=101) Likelihood to follow-up with doctor or clinic for treatment Likelihood to Recommend Source: Phase III study (N=100) Confidential & Proprietary 13 (N=101)
- 14. Intention Responses: HIVNegative Subjects from High Prevalence Sites 100 90 Percentage 80 70 60 50 40 30 20 10 0 0 Not at all likely 1 2 3 4 Definitely Scale of 0 to 4 Likelihood to get tested again for HIV (N=3903) Likelihood to use a rapid HIV home test (N=3902) Likelihood to use HIV home test to screen new sexual partners Source: Phase III study Confidential & Proprietary 14 (N=3901)
- 15. Low Levels ofAnxiety Reported Among HIV Positive Subjects Identified During Unobserved Self-test Study • Of the HIV positive subjects, most (68.6%) were described as “calm” by site staff during counseling and discussion of HIV positive results • Among HIV-positive subjects, there were no anxiety-related adverse events that required intervention by site staff when HIV positive results were discussed Source: Phase III study Confidential & Proprietary 15
- 16. Key Findings fromClinical Trial of Unobserved Self-Testing (n= 5055) • • Ninety nine percent (99%) of users successfully obtained a test result (positive or negative) Eighty eight (88) subjects of previously unknown status self-identified as HIV positive through use of the in-home test (1.7%) – • • • • Eight HIV positive subjects reported their self-test result as negative to the clinical sites (calculated sensitivity = 88/96= 92%) Predictive value of the test was very high (NPV= 99.8%; PPV=98.9%) Excellent observed specificity (4,902/4,903; >99.9%) Excellent overall accuracy* (4,990/4999; >99%) Strong benefit/risk for product approval: – – Predicted number of individuals identified (who otherwise wouldn’t have tested) Estimated number of forward transmissions prevented * Not an FDA approved label claim Source: Phase III study Confidential & Proprietary 16
- 17. OraQuick® HIV In-HomeSupport Center • Designed and developed specifically for use with the OraQuick® In-Home HIV Test • Operational 24/7/365 • Information management system for consistent responses, referral to care & complaint intake • Designed to allow the caller to remain anonymous • Scripts and materials were developed in conjunction with representatives with practical counseling experience OraQuick Phone Queue Queue 1 Test Results Queue 2 Test Usage Queue 3 Orders/Inquiries Confidential & Proprietary Goal 100% answered immediately 100% within 20 seconds 80% within 30 seconds 17
- 18. Reported Positive TestResults, Referrals and Consumer Complaints • ~400 calls per week • 212 callers reported a positive result after using the OraQuick In Home HIV test • 677 callers received referrals • Reasons for declining a referral include following up with their own HCP or testing facility • Other reasons for referrals (outside of confirmatory test) include inquiries for free testing, clinics, HIV Specialists, state hotline referrals, additional STD information Referrals 576 101 111 Positives • <0.1% complaint rate launch to date Data is sourced from OraQuick Inquiry System and is through September 30,2013 18 Confidential & Proprietary
- 19. Projection of PositivesIdentified • We believe the prevalence rate with the OTC consumer is between 1-2% • This is consistent with the data generated in the clinical study of a 1.7% prevalence rate Theoretical Projection of Total Number of Positives Identified Based on Consumer Support Center Activity 212 Positives* Identified via Consumer Support Center % of Positives Calling Support Center** 1% 5% 10% Projected Total Number of Positives 21,200 4,240 2,120 Positives as Percent of Units Sold to date 10% 2% 1% *Positives captured launch through 9/30/13** Based on prelaunch research indicating that most (96%) consumers receiving positive result will contact their healthcare professional; ~200K units sold launch through September 2013 19 Confidential & Proprietary
- 20. Web Site Support:www.OraQuick.com 2 • Engage • Learn about the OraQuick Self-Test • Education • Video tutorials • Warnings and precautions • Support • Find Counseling and Care • 2 Sales • Access to Purchase OraQuick® In-Home HIV Test 1 3 5 2 4 Confidential & Proprietary 20
- 21. National Campaign • Designedto de-stigmatize testing and drive product awareness • Launched via Advertising, Public Relations and retail promotion. “Testing for HIV is Everyone’s Thing” “Knowing is the Best Thing” Confidential & Proprietary 21
- 22. OraQuick® Retail SalesTrend +9% 20000 18000 Avg Units per Week 16000 +51% +1% 5000 -9% +4% -6% 4500 4000 +27% 14000 Units +11% Total US +2% 3500 +48% 12000 10000 3000 2500 -2% 8000 2000 6000 1500 4000 1000 2000 500 0 0 4 wk 4 wk 4 wk ending ending ending 10/27/12 11/24/12 12/22/12 • • 4 wk ending 1/19/13 4 wk ending 2/16/13 4 wk ending 3/16/13 4 wk ending 4/13/13 4 wk ending 5/11/13 4 wk ending 6/8/13 4 wk ending 7/6/13 Over 200K units sold launch to date E-Commerce accounts for an additional 9% in units Source: Nielsen data, Oct 2012-Aug 31, 2013 Confidential & Proprietary 22 4 wk ending 8/3/13 4 wk ending 08/31/13
- 23. Core Buyers Emerging • Consistentwith Expected Source of Volume by Consumer Segment – MSM and AA Estimated to contribute 86% of Volume MSM AA Urban Secondary Single Confidential & Proprietary College Towns Source: Spectra & Experian research data Hispanic American Asian American 23
- 24. Public Health Programs •Several Public Health and Advocacy groups have purchased OraQuick® In-Home HIV Test kits • Primary uses in Public Health settings relate to: – Social Networking: Provide tests to high risk individual to give to other individuals living in high risk communities – Prevention for Positives: Provide tests to individuals who have tested positive to give to partner(s) – Missed Testing Opportunities: Provide test to individuals who have declined a test at a clinic, mobile site, event, etc., giving them an opportunity to test at home Confidential & Proprietary 24
- 25. Overall Summary • OraQuickIn Home HIV Test approved in July 2012 – Approval driven by strong risk/benefit argument • Consumer support resources to maximize linkage to health services and providers; system functioning extremely well • Product up take continuing to build, as awareness builds among high risk populations • Believed to be providing substantial public health benefit in terms of number of positives identified 25
Editor's Notes
- #23 Total units sold to date Total US=170005 Total US = EComm: 185509