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

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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
11/11/2009
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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

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HIV Testing in New Jersey
Rapid HIV Testing Introduced
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Specificity

• Blood gt99.9
• Oral gt99.6
• No increase last Fall (as SF and NY)
• Not an issue, with 138 counselors at 117 sites

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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

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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

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Counseling

• Target should be substantial equivalence to
  actual current practices, not an artificial
  higher standard

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Phase I professional vs OTC?

• False positives due to over sampling
• Dont mention to consumers, or theyll do it
• So dont repeat Phase I studies
• False positives due to high storage temperature
• Repeat flex studies with higher stress?

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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