1997 Consensus Conference

1. 1997 Consensus Conference • Recommendations: • Change PHS regulations, allow rapid test results • SUDS test unacceptable • Mandate to CDC: • Make more rapid tests available • Develop diagnostic algorithms using rapid tests • 587,429 reported cases of • AIDS in the United States

2. CDC Efforts and the Availability of Rapid Tests • Based on identified public health need: • Encourage manufacturers to commercialize rapid tests in the United States. • Conduct clinical trials to establish test performance in settings of intended use. • Provide data for PMA applications to speed FDA approval. • Evaluate use of specific combinations of rapid tests to increase predictive value.

4. Walter Reed Army Institute of Research HIV Diagnostic Laboratory 5

5. Results: Retrospective Study Walter Reed Army Institute of Research HIV Diagnostic Laboratory APHL Mar’ 2000

6. Seroconversion Panels 9th CROI, 2002

7. June 2001 BPAC: CLIA Waiver • Should HIV rapid tests be eligible under standard CLIA criteria for waiver? • In favor: • CDC, NASTAD, CA Office of AIDS Prevention Programs • Opposed: • CLIAC, ASCP, ASM, AACC, ASCLS • Concerns: • Accuracy with untrained users; positive predictive value; confirmatory testing; quality control; counseling http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3760t1_01.pdf

8. Methods 1: Untrained Users • 130 participants from staff at HIV testing sites: • 93 from Los Angeles testing site, 37 from Arizona STD clinic • 129 hospital personnel: • from Atlanta, Chicago, Miami, New Orleans, and New York

9. Results: Outcomes of 427 Tests Performed by 130 Untrained Users at HIV Testing Sites Invalid results were recorded for 37 (8.6% ) tests False Negative Correct 7 (1.8%) 379 (97.2%) False Positive 4 (1.0%)

10. Results: Outcomes of 516 Tests Performed by 129 Untrained Health Care Workers Invalid results were recorded for 50 (9.6% ) tests Correct False Negative 9 (1.9%) 448 (96.1%) False Positive 9 (1.9%)*

11. Results: after Training: 5325 Tests Performed by 213 Health Care Workers Invalid 3 (0.06%) Correct False Negative 5305 (99.7%) 14 (0.26%) False Positive 3 (0.06%)

12. Positive Predictive Value: Remember the tradeoffs… • Good News: More HIV-positive people receive their test results. • Bad News: Some people will receive a false-positive result before confirmatory testing.

13. Positive Predictive Value: Newborn Screening Newborn Screening results , 1993 Arch Pediatr Adolesc Med, July 2000

14. Overall, no statistically significant difference in STD incidence in HIV-negative persons after rapid HIV counseling vs standard 2-session counseling • Behavior was similar in both groups • Incidence of new STD 17-19% within 1 year

16. Role of the AD for Lab Diagnostics

18. The argument that less-than-perfect waived testing is better than none in some cases carries special weight when battling HIV. “If you have a population where 30 percent of people don’t come back to get their results, as the CDC says is true for people testing for HIV in certain settings, then you can never have a senxitivity [for any test] tat’s greater than 70 percent.” • - Sheldon Campbell, MD, PhD • CAP Point-of-Care Testing Committee

19. Collect oral fluid specimens by swabbing gums with test device. Reduce hazards, facilitate testing in field settings

20. Positive Negative Read results in 10 minutes

22. Reactive Control Recombinant HIV-1 Peptide HIV-2 Peptide HIV-1 HIV-1 & HIV-2 Positive Negative