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Rapid HIV Testing in NJ. Evan M. Cadoff, M.D. Professor of Pathology and Laboratory Medicine UMDNJ – Robert Wood Johnson Medical School Lab Director, NJHIV rapid testing program. New Jersey Rapid HIV testing Subset of State funded CTS sites 23 agencies (grantees) 117 licensed testing sites
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Rapid HIV Testing in NJ Evan M. Cadoff, M.D. Professor of Pathology and Laboratory Medicine UMDNJ – Robert Wood Johnson Medical School Lab Director, NJHIV rapid testing program
New Jersey Rapid HIV testing • Subset of State funded CTS sites • 23 agencies (grantees) • 117 licensed testing sites • 138 trained counselors • 25,000 tests a year (60% oral) • OraQuick since November 2003 10/3/2014
New Jersey rapid HIV testing • 23 agencies (grantees) • 117 licensed testing sites • 138 trained counselors • 25,000 tests a year (60% oral) • OraQuick since November 2003
HIV Testing in New Jersey Rapid HIV Testing Introduced
Specificity • Blood: >99.9 % • Oral: >99.6% • No increase last Fall (as SF and NY) • Not an issue, with 138 counselors at 117 sites
Counseling • FDA proposal does not include a target • Our sites: 99.9% get pre and post test counseling • But funding depends on documenting counseling • Pre rapid testing, and preliminary positive rapid testing: • 66% get post test counseling • Non-scientific review of Obstetric practices: • Virtually no counseling
Counseling false positives • Rare event for trained counselors • Trained counselors uncomfortable and often incorrect • Clinicians may need assistance • Clinicians may need assistance to follow preliminary positives
Counseling • Target should be substantial equivalence to actual current practices, not an artificial higher standard
Phase I professional vs OTC? • False positives due to over sampling • Don’t mention to consumers, or they’ll do it • So don’t repeat Phase I studies • False positives due to high storage temperature • Repeat “flex studies” with higher stress?
Summary • OTC increases knowledge of HIV status • Specificity is not an issue • Evaluation of OTC counseling should be equivalence to typical, not ideal current practice • Re-evaluate “flex studies” for temperature sensitivity