Rapid HIV Testing in NJ
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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
Rapid HIV Testing in NJ
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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