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Julia R. Cummiskey, MPH 1

Increasing the predictive value of clinic-based rapid HIV antibody screening using oral fluid and whole blood testing in 10 NYC STD clinics, New York City, 2006-2007. Julia R. Cummiskey, MPH 1

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Julia R. Cummiskey, MPH 1

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  1. Increasing the predictive value of clinic-based rapid HIV antibody screening using oral fluid and whole blood testing in 10 NYC STD clinics, New York City, 2006-2007 Julia R. Cummiskey, MPH1 Maushumi Mavinkurve, MPH1, Rachel Paneth-Pollak, MPH1, Jessica Borrelli, MPH1, Alexis V. Kowalski, MPH1, Susan Blank, MD MPH1,2 1New York City Department of Health & Mental Hygiene 2Centers for Disease Control & Prevention

  2. NYC STD Clinics • The Bureau of STD Control operates 10 clinics across the five boroughs of New York City • Services are free and confidential

  3. NYC STD Clinics Services include: • Testing and treatment for Syphilis, Gonorrhea, and Chlamydia • HIV counseling and testing • Hepatitis screening and vaccination • PAP smears • Emergency contraception

  4. Rapid Testing, NYC STD Clinics Jan. ’04 – Introduced rapid testing via finger-stick (FS) Mar. ’05 – Replaced FS w/oral fluid (OF) rapid testing Nov. ’05 – Documented cluster of false pos. OF tests Dec. ’05 – Introduced FS as back-up for OF+* * OF+ : preliminary positive OF results throughout

  5. Consequences of False Positive Cluster, Nov./Dec. 2005 Patients: undue emotional stress Staff: loss of time and resources to locate and notify non-cases Patients & staff: loss of confidence in testing services

  6. Response to Cluster of False Positives, NYC, Dec. 2005 • Revised testing algorithm to include FS rapid test for OF+ samples (same assay) • Revised patient management algorithm accordingly

  7. HIV Testing Algorithm, NYC STD Clinics, Dec. 2005 Conventional (EIA / WB) Rapid Oral Fluid HIV Antibody Test or Whole-Blood (finger-stick) Oral-Fluid + Oral-Fluid - Finger-Stick Rapid HIV Test Whole-Blood (finger-stick)+ Finger-Stick + Finger-Stick - Confirmatory Testing (EIA / WB)

  8. Rapid HIV Testing, NYC STD Clinics (2006) 53,169 OF rapid HIV antibody tests 497 (0.9%) OF+

  9. Evaluation of Revised HIV Rapid Testing Algorithm Objective: Evaluate predictive value of using FS results to guide patient management

  10. Evaluation of Revised HIV Rapid Testing Algorithm Methods: Compared results of FS rapid tests and Western Blot (WB) tests for patients with OF+ test results

  11. OF Rapid HIV Testing, NYC STD Clinics, December 2005 – September 2007 • 97,653 OF rapid tests performed. • 1,171 (1.2%) were OF+ • 815 (67%) followed by FS rapid HIV test

  12. FS Rapid HIV Testing, NYC STD Clinics, December 2005 – September 2007 • 815 FS tests performed • 678 (83.2%) + • 137 (16.8%) - • All OF+ samples subjected to WB irrespective of FS results

  13. Results of WB Tests, NYC STD Clinics, December 2005 – September 2007 • 678 Finger-Stick + • 654 (98.1%) WB+ • 13 (1.9%) WB –

  14. Results of WB Tests, NYC STD Clinics, December 2005 – September 2007 • 137 Finger-Stick – • 128 (99.2%) WB – • 1 (0.8%) WB +

  15. Positive Predictive Values • PPV of OF test alone • 920/(920+146) = 86.3% • PPV of Finger-Stick following OF+ • 654/(654+13) = 98.1%

  16. Confirmatory WB Results for OF+ Tests With and Without FS Tests • 795 OF+ tests, w/ FS • 655 (82.4%) WB+ • 271 OF+ tests w/out FS • 265 (97.8%) WB+

  17. HIV Testing Algorithm in Practice, December 2005 – September 2007 OF = Oral Fluid FS = Finger-Stick WB = Western Blot

  18. Comparing FS Done & FS Not Done by Clinic December 2005 – September 2007

  19. Comparing FS Done & FS Not Done by Gender and BehaviorDecember 2005 – September 2007

  20. Comparing FS Done & FS Not Done by Testing History December 2005 – September 2007

  21. Lessons Learned • Intro. of less invasive rapid HIV testing correlates with increased demand for testing. • FS rapid HIV testing has applications for rapid OF HIV test quality assurance.

  22. Lessons Learned • Patient mgmt. can be guided by combined outcomes of 2 rapid tests. • Significant differences appear between the individuals that got a 2nd rapid test and those who did not.

  23. Post-Script • Late 2007, revised algorithm permitted rapid detection of another cluster of OF false positives. • We investigated and removed affected test lots from our clinics. • We notified other recipients of agency-purchased test kits.

  24. Acknowledgments • Julia A. Schillinger, M.D., MSc. • Preeti Pathela, DrPH • Ellen J. Klingler, MPH • Bernard M. Branson, M.D. • Thomas A. Peterman, M.D., MSc. • Special thanks to Jessica Borrelli, MPH!

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