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Evaluation of Rapid Screening Methods for Emergency Blood Collections

Evaluation of Rapid Screening Methods for Emergency Blood Collections. CPT Robert Gates, USA Armed Services Blood Program Update 12 February 2008. Agenda. Goal and Objectives Background Biokit evaluation Conclusion Other Tests-preliminary results (RV 236). Goal.

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Evaluation of Rapid Screening Methods for Emergency Blood Collections

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  1. Evaluation of Rapid Screening Methods for Emergency Blood Collections CPT Robert Gates, USA Armed Services Blood Program Update 12 February 2008

  2. Agenda • Goal and Objectives • Background • Biokit evaluation • Conclusion • Other Tests-preliminary results (RV 236)

  3. Goal Minimize TTD risk related to transfusion of freshly collected blood products in theatre

  4. Objectives Rigorously evaluate the HCV and HBsAg rapid tests currently in use in theatre Assess all other candidate tests for future use

  5. Background >250 freshly collected blood products are transfused into patients at US medical installations in OIF/OEF monthly Questionnaires and screening are either not performed or conducted in substandard fashion HIV, HCV, and HBV are rare but present in donors Rapid testing offers opportunity to mitigate risk

  6. Biorapid Evaluation

  7. Biorapid Evaluation

  8. Biorapid Evaluation Aggregate data from: WWHV301 PHV106 PHW804 Sensitivity = .281 (.138-.468) Negative Likelihood Ratio (LR-) = .719 Specificity = 13/13 = 1.00 (.794-1.00)

  9. Biorapid Evaluation Aggregate data from: PHA106 PHA206 PHA808 Sensitivity = .157 (.070-.286) Negative Likelihood Ratio (LR-) = .843 Specificity = 8/8 = 1.00 (.688-1.00)

  10. HBV HCV

  11. Biorapid Evaluation Sensitivity = .84 (.709-.928) Negative Likelihood Ratio (LR-) = .16 Specificity = 13/13 = 1.00 (.929-1.00) Aggregate data from: American Red Cross samples Roberson Donor Center samples

  12. Biorapid Evaluation Sensitivity = .875 (.730-.889) Negative Likelihood Ratio (LR-) = .125 Specificity = 8/8 = 1.00 (.916-1.00) *18 Invalid tests Aggregate data from: American Red Cross samples Roberson Donor Center samples

  13. Conclusions Biorapid Evaluation Biorapid preformed poorly against panel specimens, but had no invalid results Also poor against clinical samples (84% sensitivity for HCV, 87.5% sensitivity for HBsAg) and had an 18% invalid rate with the HBsAg test Conclusion: Biorapid hepatitis rapid tests should be replaced by tests that perform better

  14. RV 236 • Seeks to identify best rapid assays for HCV and HBsAg • Tests selected based on published material, paring down from 30 HBsAg, and 29 HCV to 6 HCV and 4 HBsAg • Positive plasma down selection (N=50 per test) complete • Selected tests will be challenged in three stages: • -commercial panels (N = 54) • -clinical samples (N = 672) • -whole blood spiked with reactive plasma (N = 168) • Ease of Use Survey

  15. * * * * * Sensitivity statistically superior Compared to Biorapid

  16. HCV Test Invalid Rate

  17. EOU Breakdown (HCV)

  18. EOU Breakdown (HCV)

  19. EOU Breakdown (HCV)

  20. EOU Breakdown (HCV)

  21. DOWN SELECTION TEST DATA (HCV) *Sensitivity based on small sample group (n=50),** 7/50 invalids (14%)

  22. HBsAg Test Invalid Rate

  23. EOU Breakdown (HBsAg)

  24. EOU Breakdown (HBsAg)

  25. EOU Breakdown (HBsAg)

  26. EOU Breakdown (HBsAg)

  27. PRELIMINARY DOWN SELECTION TEST DATA (HBsAg) *Sensitivity based on small sample group (n=50),** 1/50 invalid (2%),***3/50 invalid (6%),****18/100 invalid (18% based on n=100)

  28. Questions

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